Bristol myers squibb to highlight diversified approaches and commitment to improving outcomes for patients with cancer and serious blood disorders at asco, eha and icml 2023
Princeton, n.j.--(business wire)--bristol myers squibb (nyse: bmy) today announced the presentation of data at the 2023 american society of clinical oncology (asco) annual meeting, the european hematology association (eha) congress, and the international conference on malignant lymphoma (icml), underscoring the company’s momentum towards delivering treatment options with the hope to transform clinical outcomes for patients. data from more than 160 company-sponsored studies, investigator-sponsored studies and collaborations evaluating compounds spanning 20 cancer types and serious blood disorders will be featured across the three meetings, including the commands study, which has been selected for the official asco press program (abstract #7003) and eha plenary session (abstract #s102). “we look forward to sharing our research during asco, eha and icml, demonstrating the diversity of our assets, cutting-edge pipeline, and science-driven strategy focused on shaping the next generation of cancer care,” said samit hirawat, m.d., executive vice president, chief medical officer, global drug development, bristol myers squibb. “the breadth of data and results illustrate how we are leveraging novel technologies to develop therapies that disrupt the course of disease for patients with solid tumors, blood cancers, and blood disorders. positive study outcomes are critical, and so is ensuring those results represent and can benefit a diverse population of patients. our health equity commitments are enabling inclusive innovation, better science and greater reach of our medicines to the patients who need them most.” key data being presented by bristol myers squibb at asco, eha and icml 2023 include: hematology first disclosure of data from the phase 3 commands study of reblozyl (luspatercept-aamt) versus epoetin alfa, an erythropoiesis-stimulating agent (esa), demonstrated highly statistically significant and clinically meaningful improvement in patients with anemia associated with very low- to intermediate-risk myelodysplastic syndromes, who require red blood cell (rbc) transfusions and are esa-naÏve. (asco/eha) preliminary results from the dose-escalation and expansion components of the phase 1 cc-93269-mm-001 study demonstrate subcutaneous administration of bispecific t-cell engager alnuctamab exhibited promising dose-dependent anti-tumor activity in heavily pretreated multiple myeloma, with a high proportion of responders achieving minimal residual disease negativity. (eha) results from the dose-escalation components of a phase 1/2 study evaluating bet inhibitor bms-986158 as monotherapy and in combination with ruxolitinib or inrebic (fedratinib), show generally manageable safety and robust spleen volume reduction in patients with intermediate- or high-risk myelofibrosis. (eha) first disclosure of clinical data from a phase 1b study evaluating golcadomide (cc-99282), a novel celmodtm agent, in combination with r-chop in patients with previously untreated aggressive b-cell lymphoma will be presented. (icml) results from a dose-expansion cohort of the phase 1/2 cc-92480-mm-001 study, evaluating novel celmod agent, mezigdomide, with dexamethasone in patients with relapsed/refractory multiple myeloma, showed the combination’s safety profile and promising efficacy in patients with triple-class refractory multiple myeloma. (eha) cell therapy first disclosure of data from the primary analysis of the transcend cll 004 study of breyanzi (lisocabtagene maraleucel) demonstrated deep and durable responses and a manageable safety profile, with no new safety signals, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. (asco) multiple analyses from the karmma-3 study showed improved health-related quality of life (hrqol) and patient-reported outcomes, in addition to lower risk of disease progression, with abecma (idecabtagene vicleucel), regardless of baseline high-risk disease or number of prior lines of therapy, in patients with triple-class exposed relapsed and refractory multiple myeloma. (asco/eha) interim results from phase 1 study of gprc5d car t (bms-986393/cc-95266) demonstrated durable responses with an overall generally manageable safety profile, including in patients with prior bcma-directed therapy. (eha) solid tumor results from the registrational trident-1 trial showed durable clinical activity with repotrectinib in ros1 tyrosine kinase inhibitor (tki)-naÏve and tki-pretreated patients with locally advanced or metastatic ros1-positive nsclc with or without baseline central nervous system metastases, including robust intracranial responses. (asco) four-year data from the phase 3 checkmate -9la trial reinforce durable, long-term survival with opdivo (nivolumab) plus yervoy (ipilimumab) with two cycles of chemotherapy for patients with metastatic nsclc, including subgroups with higher unmet needs. (asco) three-year results demonstrated long-term clinical benefit of neoadjuvant opdivo with chemotherapy in patients with resectable nsclc who received definitive surgery in the phase 3 checkmate -816 trial. (asco) biomarker analyses from the phase 3 checkmate -76k trial support a potential clinical benefit of opdivo for the adjuvant treatment of patients with stage iib/c melanoma, across all biomarker sub-groups. (asco) three-year data from the phase 3 checkmate -649 trial evaluating opdivo plus chemotherapy continue to demonstrate durable long-term survival and hrqol benefits in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. (asco) two-year data from the phase 2/3 relativity-047 trial showed consistent benefit with the company’s third distinct checkpoint inhibitor opdualag (nivolumab and relatlimab-rmbw) in patients with previously untreated metastatic or unresectable melanoma. (asco) please see below for important safety information and full prescribing information for reblozyl, opdualag, opdivo, and opdivo+yervoy. please see below for important safety information and full prescribing information, including boxed warnings, for abecma, breyanzi and inrebic. investor event bristol myers squibb will host a virtual investor event on tuesday, june 6, 2023, from 7:00-8:00 a.m. ct/8:00-9:00 a.m. et to discuss data presented at asco. company executives will provide an overview of data presented and address questions from investors and analysts. investors and the general public are invited to listen to a live webcast of the event at http://investor.bms.com. an archived edition of the session will be available later that day. summary of presentations select bristol myers squibb studies at the 2023 asco annual meeting include: abstract title author presentation type/# session title session date/time (edt) acute myeloid leukemia implications for acute myeloid leukemia (aml) treatment and care during the covid-19 pandemic: a connect myeloid registry study. bart l. scott poster abstract #7021 hematologic malignancies—leukemia, myelodysplastic syndromes, and allotransplant monday, june 5, 2023 9:00 am – 12:00 pm gastrointestinal first-line (1l) nivolumab (nivo) + ipilimumab (ipi) in patients (pts) with microsatellite instability-high/mismatch repair deficient (msi-h/dmmr) metastatic colorectal cancer (mcrc): 64-month (mo) follow-up from checkmate 142. heinz-josef lenz poster abstract #3550 gastrointestinal cancer—colorectal and anal monday, june 5, 2023 9:00 am – 12:00 pm predictive value of tumor-infiltrating lymphocyte (til) dynamics in the tumor microenvironment (tme) during preoperative chemoradiotherapy (crt) on pathologic complete response (pcr) in microsatellite-stable (mss) locally advanced rectal cancer (larc). mitsuho imai poster abstract #3608 gastrointestinal cancer—colorectal and anal monday, june 5, 2023 9:00 am – 12:00 pm nivolumab (nivo) plus chemotherapy (chemo) vs chemo as first-line (1l) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (gc/gejc/eac): 3-year follow-up from checkmate 649. yelena y. janjigian poster abstract #4025 gastrointestinal cancer—gastroesophageal, pancreatic, and hepatobiliary monday, june 5, 2023 9:00 am – 12:00 pm health-related quality of life (hrqol) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (gc/gejc) or esophageal adenocarcinoma (eac): 36-month results of nivolumab plus chemotherapy (n+c) versus (c) from checkmate 649. elena elimova poster abstract #4038 gastrointestinal cancer—gastroesophageal, pancreatic, and hepatobiliary monday, june 5, 2023 9:00 am – 12:00 pm genitourinary health-related quality of life (hrqol) of risk-based patient subgroups with advanced renal cell cancer (arcc) treated with nivolumab plus cabozantinib (nivo+cabo) vs sunitinib (sun) in the checkmate 9er trial. david cella poster abstract #4527 genitourinary cancer—kidney and bladder saturday, june 3, 2023 9:00 am – 12:00 pm adjuvant nivolumab plus ipilimumab vs placebo for patients with localized renal cell carcinoma at high risk of relapse after nephrectomy: subgroup analyses from the phase 3 checkmate 914 (part a) trial. robert j. motzer oral abstract #4506 genitourinary cancer—kidney and bladder monday, june 5, 2023 12:30 pm – 3:30pm gynecologic preliminary antitumor activity of the combination of com701 + bms-986207 + nivolumab in patients with recurrent, metastatic mss endometrial cancer. drew w. rasco poster abstract #5595 gynecologic cancer monday, june 5, 2023 2:15 pm – 5:15 pm efficacy and final safety analysis of pre- and co-administration of nivolumab (nivo) with concurrent chemoradiation (ccrt) followed by nivo maintenance therapy in patients (pts) with locally advanced cervical carcinoma (lacvca): results from the phase i trial, gotic-018. kazuto nakamura poster abstract #5519 gynecologic cancer monday, june 5, 2023 5:30 pm – 7:00 pm preclinical testing of farletuzumab ecteribulin (fzec [morab-202]) and morab-109, folate receptor Α and mesothelin targeting antibody-drug conjugates (adcs), in rare gynecologic cancers. cassandra vandenberg publication only abstract #e17634 gynecologic cancer n/a head & neck a phase 2, open-label, multicenter study investigating efficacy and safety of rp3 oncolytic immunotherapy combined with other therapies in patients with locoregionally advanced or recurrent squamous cell carcinoma of the head and neck. kevin joseph harrington poster abstract #tps6106 head and neck cancer monday, june 5, 2023 2:15 pm – 5:15 pm lymphoma longitudinal, prospective cardiovascular and metabolic risk in treatment-naive patients with chronic myeloid leukemia in chronic phase (cml-cp) starting tyrosine kinase inhibitor (tki) therapy in a real-world setting. javid j. moslehi poster abstract #7053 hematologic malignancies—leukemia, myelodysplastic syndromes, and allotransplant monday, june 5, 2023 9:00 am – 12:00 pm subgroup analyses of primary refractory (refr) vs early relapsed (rel) large b-cell lymphoma (lbcl) from the transform study of lisocabtagene maraleucel (liso-cel) vs standard of care (soc) as second-line (2l) therapy. loretta j. nastoupil poster abstract #7526 hematologic malignancies—lymphoma and chronic lymphocytic leukemia monday, june 5, 2023 9:00 am – 12:00 pm response-adapted therapy (tx) with nivolumab plus brentuximab vedotin (nivo + bv) without autologous hematopoietic cell transplantation (auto-hct) in children, adolescents, and young adults (caya) with low-risk relapsed/refractory (r/r) classic hodgkin lymphoma (chl): checkmate 744. paul david harker-murray poster abstract #7515 hematologic malignancies—lymphoma and chronic lymphocytic leukemia monday, june 5, 2023 2:15 pm – 3:45 pm lisocabtagene maraleucel (liso-cel) in r/r chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll): primary analysis of transcend cll 004. tanya siddiqi oral abstract #7501 hematologic malignancies—lymphoma and chronic lymphocytic leukemia tuesday, june 6, 2023 10:45 am – 1:45 pm melanoma the validity of a machine learning algorithm in predicting response to immune checkpoint inhibitors in melanoma. faisal fa’ak poster abstract #9523 melanoma/skin cancers saturday, june 3, 2023 2:15 pm – 5:15 pm preliminary safety and efficacy results from an open-label, multicenter, phase 1 study of rp2 as a single agent and in combination with nivolumab in a cohort of patients with uveal melanoma. joseph j. sacco poster abstract #9527 melanoma/skin cancers saturday, june 3, 2023 2:15 pm – 5:15 pm durable clinical outcomes in patients (pts) with advanced melanoma and progression-free survival (pfs) ≥3y on nivolumab (nivo) ± ipilimumab (ipi) or ipi in checkmate 067. f. hodi poster abstract #9542 melanoma/skin cancers saturday, june 3, 2023 2:15 pm – 5:15 pm efficacy and safety of first-line (1l) nivolumab plus relatlimab (nivo + rela) versus nivo plus ipilimumab (nivo + ipi) in advanced melanoma: an indirect treatment comparison (itc) using patient-level data (pld). dirk schadendorf poster abstract #9552 melanoma/skin cancers saturday, june 3, 2023 2:15 pm – 5:15 pm association of circulating tumor dna kinetics with disease recurrence in patients with stage iib/c/iv melanoma treated with adjuvant immunotherapy in checkmate 238. mahrukh m. syeda poster abstract #9577 melanoma/skin cancers saturday, june 3, 2023 2:15 pm – 5:15 pm nivolumab (nivo) plus relatlimab (rela) vs nivo in previously untreated metastatic or unresectable melanoma: 2-year results from relativity-047. hussein a. tawbi oral abstract #9502 melanoma/skin cancers monday, june 5, 2023 4:00 pm – 7:00 pm association of biomarkers (bms) with efficacy of adjuvant nivolumab (nivo) vs placebo (pbo) in patients with resected stage iib/c melanoma (ca209 -76k). georgina v. long oral abstract #9504 melanoma/skin cancers monday, june 5, 2023 4:00 pm – 7:00 pm merkel cell carcinoma non-comparative, open-label, international, multicenter phase i/ii study of nivolumab (nivo) ± ipilimumab (ipi) in patients (pts) with recurrent/metastatic merkel cell carcinoma (mcc) (checkmate 358). shailender bhatia oral abstract #9506 melanoma/skin cancers monday, june 5, 2023 4:00 pm – 7:00 pm multiple myeloma baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the karmma-3 study of triple-class–exposed (tce) relapsed and refractory multiple myeloma (rrmm). julia piasecki poster abstract #8031 hematologic malignancies—plasma cell dyscrasia monday, june 5, 2023 9:00 am – 12:00 pm health related quality of life (hrqol) in patients with triple-class-exposed relapsed/refractory multiple myeloma (tce rrmm) treated with idecabtagene vicleucel (ide-cel) versus standard regimens: patient-reported outcomes (pros) from karmma-3 phase 3 randomized controlled trial (rct). michel delforge poster abstract #8032 hematologic malignancies—plasma cell dyscrasia monday, june 5, 2023 9:00 am – 12:00 pm tumor-intrinsic features associated with progression-free survival (pfs) in patients (pts) with relapsed and refractory multiple myeloma (rrmm) treated with idecabtagene vicleucel (ide-cel). nicholas strong poster abstract #8035 hematologic malignancies—plasma cell dyscrasia monday, june 5, 2023 9:00 am – 12:00 pm excaliber-rrmm: a phase 3, two-stage study of iberdomide, daratumumab, and dexamethasone (iberdd) versus daratumumab, bortezomib, and dexamethasone (dvd) in patients (pts) with relapsed/refractory multiple myeloma (rrmm). sagar lonial poster abstract #tps8069 hematologic malignancies—plasma cell dyscrasia monday, june 5, 2023 9:00 am – 12:00 pm a phase 3, two-stage, randomized study of mezigdomide, carfilzomib, and dexamethasone (mezikd) versus carfilzomib and dexamethasone (kd) in relapsed/refractory multiple myeloma (rrmm): successor-2. paul g. richardson poster abstract #tps8070 hematologic malignancies—plasma cell dyscrasia monday, june 5, 2023 9:00 am – 12:00 pm myelodysplastic syndrome efficacy and safety results from the commands trial: a phase 3 study evaluating luspatercept vs epoetin alfa in erythropoiesis-stimulating agent (esa)-‑naive transfusion-dependent (td) patients (pts) with lower-‑risk myelodysplastic syndromes (lr-mds). guillermo garcia-manero oral abstract #7003 hematologic malignancies—leukemia, myelodysplastic syndromes, and allotransplant friday, june 2, 2023 2:00 pm – 5:00 pm hematologic and transfusion outcomes in patients (pts) with lower-risk myelodysplastic syndromes (lr-mds) receiving luspatercept: real-world assessment in the community practice setting. sudipto mukherjee poster abstract #7057 hematologic malignancies—leukemia, myelodysplastic syndromes, and allotransplant monday, june 5, 2023 9:00 am – 12:00 pm clinical outcomes by sf3b1 mutation status in patients (pts) with lower-risk myelodysplastic syndrome (lr-mds) retreated with erythropoiesis-stimulating agents (esas). adeola y. makinde poster abstract #7071 hematologic malignancies—leukemia, myelodysplastic syndromes, and allotransplant monday, june 5, 2023 9:00 am – 12:00 pm a phase 2/3 trial of oral azacitidine (oral-aza) in patients (pts) with low- or intermediate-risk myelodysplastic syndromes (mds). guillermo garcia-manero poster abstract #tps7083 hematologic malignancies—leukemia, myelodysplastic syndromes, and allotransplant monday, june 5, 2023 9:00 am – 12:00 pm myelofibrosis safety and efficacy of luspatercept for the treatment of anemia in patients with myelofibrosis: results from the ace-536-mf-001 study. aaron thomas gerds poster abstract #7016 hematologic malignancies—leukemia, myelodysplastic syndromes, and allotransplant monday, june 5, 2023 12:30 pm – 2:00 pm thoracic phase 2 small cell lung cancer (sclc) cohort of a phase 1b/2 trial of a liposomal formulation of eribulin in combination with nivolumab. koichi azuma poster abstract #8593 lung cancer—non-small cell local-regional/small cell/other thoracic cancers sunday, june 4, 2023 9:00 am – 12:00 pm clinical outcomes with neoadjuvant nivolumab (n) + chemotherapy (c) vs c by definitive surgery in patients (pts) with resectable nsclc: 3-y results from the phase 3 checkmate 816 trial. jonathan spicer poster abstract #8521 lung cancer—non-small cell local-regional/small cell/other thoracic cancers sunday, june 4, 2023 12:30 pm – 2:00 pm intracranial and systemic efficacy of repotrectinib in advanced ros1 fusion-positive (ros1+) non-small cell lung cancer (nsclc) and central nervous system metastases (cns mets) in the phase 1/2 trident-1. jessica jiyeong lin poster abstract #9017 lung cancer—non-small cell metastatic sunday, june 4, 2023 5:30 pm – 7:00 pm first-line (1l) nivolumab (n) + ipilimumab (i) + chemotherapy (c) vs c alone in patients (pts) with metastatic nsclc (mnsclc) from checkmate 9la: 4‑y clinical update and outcomes by tumor histologic subtype (ths). david paul carbone poster abstract #lba9023 lung cancer—non-small cell metastatic sunday, june 4, 2023 5:30 pm – 7:00 pm all abstracts except late-breaking abstracts will be available on the asco website at 5:00 pm edt on thursday, may 25. all late-breaking abstracts will be available on the asco website at 8:00 am edt on the day of the scientific session for the abstract presentation. select bristol myers squibb studies at the 2023 eha congress include: abstract title author presentation type/# session date/ time (edt) acute myeloid leukemia longitudinal characterization of molecular variants at remission and relapse: subanalyisis of the quazar aml-001 trial. andrew wei poster abstract #p411 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) disease monitoring of npm1-mutant (mut) acute myeloid leukemia (aml) using measurable residual disease (mrd) assessments during oral azacitidine (oral-aza) treatment (tx): a quazar aml-001 subanalysis. gail roboz poster abstract #p459 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) a real-world evaluation of treatment patterns and outcomes of acute myeloid leukemia induction therapies in the community setting. keri maher poster abstract #p515 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) phase 1b omniverse trial: safety and tolerability of oral azacitidine in combination with venetoclax for treatment of acute myeloid leukemia. shaun fleming poster abstract #p567 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) real-world characteristics and use of antiemetic therapies among patients with acute myeloid leukemia treated with oral azacitidine maintenance therapy. ying qui poster abstract #p587 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) implications of registry data for acute myeloid leukemia (aml) treatment and care during the covid-19 pandemic. john kelly poster abstract #p589 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) beta thalassemia effect of luspatercept on bone mineral density in patients with beta-thalassemia enrolled in the phase 3 believe trial. thomas d. coates poster abstract #p1466 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) long-term erythroid response data from patients (pts) with non-transfusion-dependent beta-thalassemia (ntdt) receiving luspatercept in the beyond trial. ali t. taher oral abstract #s273 sunday, june 11, 2023 5:30 – 6:45 am (11:30 am – 12:45 pm cest) alpha thalassemia trial in progress: a phase 2, double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of luspatercept to treat anemia in adults with alpha-thalassemia. vip viprakasit abstract only publication abstract #pb2535 n/a lymphoma economic burden in chronic lymphocytic leukemia (cll) for patients with ≥2 prior lines of therapy including a bruton tyrosine kinase inhibitor (btki) and/or b-cell lymphoma 2 inhibitor (bcl2i). farrukh awan poster abstract #p1696 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) qualitative interviews to describe burden in patients (pt) with third-line or later cll/sll with prior exposure to bruton tyrosine kinase inhibitor (btki) and/or b-cell lymphoma 2 inhibitor (bcl2i). mona l martin abstract only publication abstract #pb2696 n/a multiple myeloma synergistic antitumor activity of the bcma 2+1 t cell engager (tce) alnuctamab (alnuc; bms-986349; cc-93269) and celmod agents in multiple myeloma (mm) preclinical models. bruno paiva poster abstract #p799 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) baseline and early post-infusion biomarkers associated with optimal response to idecabtagene vicleucel (ide-cel) in the karmma-3 study of triple-class-exposed relapsed and refractory multiple myeloma. marc s. raab poster abstract #p801 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) baseline characteristics identifying patients with multiple myeloma treated with idecabtagene vicleucel (ide-cel; bb2121) who are at risk for severe/refractory inflammatory adverse events. yi lin poster abstract #p809 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) soluble factors correlated with cytokine release syndrome (crs) with iv vs subcutaneous (sc) alnuctamab (alnuc; bms-986349; cc-93269) in patients with relapsed/refractory multiple myeloma (rrmm). luciano costa poster abstract #p825 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) saloman manier poster abstract #p866 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) mezigdomide (mezi) plus dexamethasone (dex) in patients (pts) with relapsed/refractory multiple myeloma (rrmm): results from the dose-expansion phase of the cc-92480-mm-001 trial. nizar j. bahlis poster abstract #p868 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) idecabtagene vicleucel (ide-cel) in patients with an inadequate response to frontline autologous stem cell transplantation (asct): results from karmma-2 cohort 2c. melissa alsina poster abstract #p871 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) pomalidomide, daratumumab, and dexamethasone after lenalidomide treatment in patients with relapsed or refractory multiple myeloma (rrmm): final overall survival analysis of the phase 2 mm-014 study. nizar j. bahlis poster abstract #p882 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) alnuctamab (alnuc; bms-986349; cc-93269), a bcma × cd3 t-cell engager, in patients (pts) with relapsed/refractory multiple myeloma (rrmm): latest results from a phase 1 first-in-human clinical study. sandy w. wong poster abstract #p883 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) patient reported outcomes in triple class exposed, relapsed/refractory multiple myeloma (tce rrmm) patients in karmma-3 trial (phase 3 rct): idecabtagene vicleucel (ide-cel) versus standard regimens. michel delforge poster abstract #p905 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) treatment patterns and clinical outcomes of patients with multiple myeloma previously treated with lenalidomide and an anti-cd38 monoclonal antibody: findings from the connect® mm disease registry. rafat abonour poster abstract #p915 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) real-world clinical outcomes among triple-class exposed relapsed refractory multiple myeloma patients in us and europe: preamble registry study. hartmut goldschmidt poster abstract #p945 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) bms-986393 (cc-95266), a g protein–coupled receptor class c group five member d (gprc5d)–targeted car t-cell therapy for relapsed/refractory multiple myeloma (rrmm): results from a phase 1 study. susan bal oral abstract #s193 saturday, june 10, 2023 5:30 – 6:45 am (11:30 am – 12:45 pm cest) idecabtagene vicleucel (ide-cel) vs standard regimens in patients with triple-class–exposed (tce) relapsed and refractory multiple myeloma (rrmm): a karmma-3 analysis in high-risk subgroups. krina patel oral abstract #s195 saturday, june 10, 2023 10:30 – 11:45 am (4:30 – 5:45 pm cest) elotuzumab or daratumumab in combination with pomalidomide and dexamethasone (epd and dpd) in relapsed refractory multiple myeloma (rrmm): a network meta-analysis. adriana cury abstract only publication abstract #pb2095 n/a myelodysplastic syndromes luspatercept versus epoetin alfa for treatment (tx) of anemia in esa-naÏve patients with lower-risk myelodysplastic syndromes(lr-mds) patients (pts) requiring rbc transfusions: data from the commands study. matteo giovanni della porta oral plenary and special session abstract #s102 saturday, june 10, 2023 8:45 – 10:15 am (2:45 – 4:15 pm cest) luspatercept restores effective erythropoiesis and provides superior and sustained benefit vs epoetin alfa: biomarker analysis from the phase 3 commands study. uwe platzbecker poster abstract #p693 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) distinct splicing alternations associated with clinical response to luspatercept in patients with lower-risk myelodysplastic syndromes from the medalist study. amit verma poster abstract #p697 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) treatment patterns and outcomes among patients with lower-risk myelodysplastic syndromes receiving luspatercept in routine clinical practice in the united states. sudipto mukherjee poster abstract #p733 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) first-line treatment patterns and outcomes among patients with the newly diagnosed myelodysplastic syndromes: a global, retrospective observational cohort study. amer m. zeidan abstract only publication abstract #pb2010 n/a myelofibrosis efficacy and safety of luspatercept for the treatment of anemia in patients with myelofibrosis: results from the ace-536-mf-001 study. francesco passamonti oral abstract #s167 friday, june 9, 2023 8:45 – 10:00 am (2:45 – 4:00 pm cest) fedratinib is effective in ruxolitinib-resistant cells: clinical and preclinical correlations. vikas gupta poster abstract #p997 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) real-world treatment patterns and healthcare resource utilization in myelofibrosis patients with anemia. john mascarenhas poster abstract #p1059 friday, june 9, 2023 12:00 – 1:00 pm (6:00 – 7:00 pm cest) bms-986158, a potent bet inhibitor, as monotherapy and in combination with ruxolitinib or fedratinib in intermediate- or high-risk myelofibrosis (mf): results from a phase 1/2 study. haifa kathrin al-ali oral abstract #s213 saturday, june 10, 2023 all eha abstracts except late-breaking abstracts will be available on may 11. all late-breaking abstracts will be available on june 1. select bristol myers squibb studies at the 2023 icml annual meeting include: abstract title author presentation type/# session title session date/ time (edt) non-hodgkin lymphoma cc-99282 plus r-chop in patients (pts) with previously untreated aggressive b-cell lymphoma (abcl): early safety and efficacy results from a phase 1b study. javier munoz poster abstract #438 phase i-ii wednesday, june 14, 2023 6:00am – 12:00 pm (12:00 – 6:00 pm cest) thursday, june 15 – friday, june 16, 2023 4:00 am – 12:00 pm (10:00 am – 6:00 pm cest) open-label phase 1/2 study of cc-99282, a cereblon e3 ligase modulator (celmod) agent ± rituximab, in patients with relapsed/refractory (r/r) non-hodgkin lymphoma (nhl). jean-marie michot oral abstract #90 session 14 novel agents saturday, june 17, 2023 2:45 – 4:15 am (9:45 – 10:15 am cest) chronic lymphocytic leukemia health-related quality of life in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with liso-cel in transcend cll 004. s.s. kenderian poster abstract #400 car-t (cellular therapies) wednesday, june 14, 2023 6:00am – 12:00 pm (12:00 – 6:00 pm cest) thursday, june 15 – friday, june 16, 2023 4:00 am – 12:00 pm (10:00 am ‒ 6:00 pm cest) lisocabtagene maraleucel (liso-cel) in r/r chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll): primary analysis of transcend cll 004. tanya siddiqi oral abstract #26 session 4 cll and richter syndrome thursday, june 15, 2023 7:45 – 9:15 am (1:45 – 3:15 pm cest) large b cell lymphoma comparison of overall survival of lisocabtagene maraleucel (liso-cel) versus standard of care (soc) adjusting for crossover in second-line (2l) r/r large b-cell lymphoma. franck morschhauser poster abstract #332 dlbcl wednesday, june 14, 2023 6:00am – 12:00 pm (12:00 – 6:00 pm cest) thursday, june 15 – friday, june 16, 2023 4:00 am – 12:00 pm (10:00 am – 6:00 pm cest) lisocabtagene maraleucel (liso-cel) vs standard of care (soc) as second-line therapy in large b-cell lymphoma (transform study): subgroup analyses by prior therapy response. loretta j. nastoupil oral abstract #138 session 8 “focus on...” large b-cell and double hit lymphomas thursday, june 15 11:00 am – 12:00 pm (5:00 ‒ 6:00 pm cest) all icml accepted abstracts (except encore abstracts) will be available on june 9. bristol myers squibb: creating a better future for people with cancer bristol myers squibb is inspired by a single vision — transforming patients’ lives through science. the goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. building on a legacy across a broad range of cancers that have changed survival expectations for many, bristol myers squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. cancer can have a relentless grasp on many parts of a patient’s life, and bristol myers squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. because as a leader in cancer care, bristol myers squibb is working to empower all people with cancer to have a better future. learn more about the science behind cell therapy and ongoing research at bristol myers squibb here. reblozyl indications reblozyl is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (rbc) transfusions. reblozyl is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate- risk myelodysplastic syndromes with ring sideroblasts (mds-rs) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (mds/mpn- rs-t). reblozyl is not indicated for use as a substitute for rbc transfusions in patients who require immediate correction of anemia. important safety information warnings and precautions thrombosis/thromboembolism in adult patients with beta thalassemia, thromboembolic events (tee) were reported in 8/223 (3.6%) of reblozyl-treated patients. tees included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. consider thromboprophylaxis in patients at increased risk of tee. monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly. hypertension hypertension was reported in 10.7% (61/571) of reblozyl-treated patients. across clinical studies, the incidence of grade 3 to 4 hypertension ranged from 1.8% to 8.6%. in patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (sbp) ≥130 mm hg and 33 (16.6%) patients developed diastolic blood pressure (dbp) ≥80 mm hg. in adult patients with mds with normal baseline blood pressure, 26 (29.9%) patients developed sbp ≥130 mm hg and 23 (16.4%) patients developed dbp ≥80 mm hg. monitor blood pressure prior to each administration. manage new or exacerbations of preexisting hypertension using anti-hypertensive agents. extramedullary hematopoietic masses in adult patients with transfusion-dependent beta thalassemia, emh masses were observed in 3.2% of reblozyl-treated patients, with spinal cord compression symptoms due to emh masses occurring in 1.9% of patients (believe and reblozyl long-term follow-up study). in a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of emh masses was observed in 6.3% of reblozyl-treated patients vs. 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to emh masses occurring in 1 patient with a prior history of emh. reblozyl is not indicated for use in patients with non-transfusion-dependent beta thalassemia. possible risk factors for the development of emh masses in patients with beta thalassemia include history of emh masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (2% included pneumonia and vomiting. no fatal adverse reactions occurred in patients who received opdivo in combination with platinum-doublet chemotherapy. in checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). the most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. in checkmate 9la, serious adverse reactions occurred in 57% of patients (n=358). the most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. in checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving opdivo (n=418). the most frequent serious adverse reactions reported in ≥2% of patients receiving opdivo were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. in checkmate 057, fatal adverse reactions occurred; these included events of infection (7 patients, including one case of pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient). in checkmate 743, serious adverse reactions occurred in 54% of patients receiving opdivo plus yervoy. the most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. in checkmate 214, serious adverse reactions occurred in 59% of patients receiving opdivo plus yervoy (n=547). the most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. in checkmate 9er, serious adverse reactions occurred in 48% of patients receiving opdivo and cabozantinib (n=320). the most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection, and hyponatremia. fatal intestinal perforations occurred in 3 (0.9%) patients. in checkmate 025, serious adverse reactions occurred in 47% of patients receiving opdivo (n=406). the most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. in checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). serious adverse reactions occurred in 26% of patients. the most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion- related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last opdivo dose, 2 from infection 8 to 9 months after completing opdivo, and 6 from complications of allogeneic hsct. in checkmate 141, serious adverse reactions occurred in 49% of patients receiving opdivo (n=236). the most frequent serious adverse reactions reported in ≥2% of patients receiving opdivo were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. in checkmate 275, serious adverse reactions occurred in 54% of patients receiving opdivo (n=270). the most frequent serious adverse reactions reported in ≥2% of patients receiving opdivo were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. in checkmate 274, serious adverse reactions occurred in 30% of patients receiving opdivo (n=351). the most frequent serious adverse reaction reported in ≥2% of patients receiving opdivo was urinary tract infection. fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%). in checkmate 142 in msi-h/dmmr mcrc patients receiving opdivo with yervoy (n=119), serious adverse reactions occurred in 47% of patients. the most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. in checkmate 040, serious adverse reactions occurred in 59% of patients receiving opdivo with yervoy (n=49). serious adverse reactions reported in ≥4% of patients were pyrexia, diarrhea, anemia, increased ast, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. in attraction-3, serious adverse reactions occurred in 38% of patients receiving opdivo (n=209). serious adverse reactions reported in ≥2% of patients who received opdivo were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia. the following fatal adverse reactions occurred in patients who received opdivo: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%). in checkmate 577, serious adverse reactions occurred in 33% of patients receiving opdivo (n=532). a serious adverse reaction reported in ≥2% of patients who received opdivo was pneumonitis. a fatal reaction of myocardial infarction occurred in one patient who received opdivo. in checkmate 648, serious adverse reactions occurred in 62% of patients receiving opdivo in combination with chemotherapy (n=310). the most frequent serious adverse reactions reported in ≥2% of patients who received opdivo with chemotherapy were pneumonia (11%), dysphagia (7%), esophageal stenosis (2.9%), acute kidney injury (2.9%), and pyrexia (2.3%). fatal adverse reactions occurred in 5 (1.6%) patients who received opdivo in combination with chemotherapy; these included pneumonitis, pneumatosis intestinalis, pneumonia, and acute kidney injury. in checkmate 648, serious adverse reactions occurred in 69% of patients receiving opdivo in combination with yervoy (n=322). the most frequent serious adverse reactions reported in ≥2% who received opdivo in combination with yervoy were pneumonia (10%), pyrexia (4.3%), pneumonitis (4.0%), aspiration pneumonia (3.7%), dysphagia (3.7%), hepatic function abnormal (2.8%), decreased appetite (2.8%), adrenal insufficiency (2.5%), and dehydration (2.5%). fatal adverse reactions occurred in 5 (1.6%) patients who received opdivo in combination with yervoy; these included pneumonitis, interstitial lung disease, pulmonary embolism, and acute respiratory distress syndrome. in checkmate 649, serious adverse reactions occurred in 52% of patients treated with opdivo in combination with chemotherapy (n=782). the most frequent serious adverse reactions reported in ≥2% of patients treated with opdivo in combination with chemotherapy were vomiting (3.7%), pneumonia (3.6%), anemia (3.6%), pyrexia (2.8%), diarrhea (2.7%), febrile neutropenia (2.6%), and pneumonitis (2.4%). fatal adverse reactions occurred in 16 (2.0%) patients who were treated with opdivo in combination with chemotherapy; these included pneumonitis (4 patients), febrile neutropenia (2 patients), stroke (2 patients), gastrointestinal toxicity, intestinal mucositis, septic shock, pneumonia, infection, gastrointestinal bleeding, mesenteric vessel thrombosis, and disseminated intravascular coagulation. common adverse reactions in checkmate 037, the most common adverse reaction (≥20%) reported with opdivo (n=268) was rash (21%). in checkmate 066, the most common adverse reactions (≥20%) reported with opdivo (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). in checkmate 067, the most common (≥20%) adverse reactions in the opdivo plus yervoy arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). in checkmate 067, the most common (≥20%) adverse reactions in the opdivo arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). in checkmate 238, the most common adverse reactions (≥20%) reported in opdivo-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). the most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). in checkmate 816, the most common (>20%) adverse reactions in the opdivo plus chemotherapy arm (n=176) were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%). in checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). in checkmate 9la, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). in checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving opdivo (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. in checkmate 743, the most common adverse reactions (≥20%) in patients receiving opdivo plus yervoy were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%), and pruritus (21%). in checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with opdivo plus yervoy (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). in checkmate 9er, the most common adverse reactions (≥20%) in patients receiving opdivo and cabozantinib (n=320) were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%). in checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving opdivo (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). in checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving opdivo (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). in checkmate 141, the most common adverse reactions (≥10%) in patients receiving opdivo (n=236) were cough (14%) and dyspnea (14%) at a higher incidence than investigator’s choice. in checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving opdivo (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). in checkmate 274, the most common adverse reactions (≥20%) reported in patients receiving opdivo (n=351) were rash (36%), fatigue (36%), diarrhea (30%), pruritus (30%), musculoskeletal pain (28%), and urinary tract infection (22%). in checkmate 142 in msi-h/dmmr mcrc patients receiving opdivo as a single agent (n=74), the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). in checkmate 142 in msi-h/dmmr mcrc patients receiving opdivo with yervoy (n=119), the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). in checkmate 040, the most common adverse reactions (≥20%) in patients receiving opdivo with yervoy (n=49), were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%),decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%). in attraction-3, the most common adverse reactions (≥20%) in opdivo-treated patients (n=209) were rash (22%) and decreased appetite (21%). in checkmate 577, the most common adverse reactions (≥20%) in patients receiving opdivo (n=532) were fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%), and cough (20%). in checkmate 648, the most common adverse reactions (≥20%) in patients treated with opdivo in combination with chemotherapy (n=310) were nausea (65%), decreased appetite (51%), fatigue (47%), constipation (44%), stomatitis (44%), diarrhea (29%), and vomiting (23%). in checkmate 648, the most common adverse reactions reported in ≥20% of patients treated with opdivo in combination with yervoy were rash (31%), fatigue (28%), pyrexia (23%), nausea (22%), diarrhea (22%), and constipation (20%). in checkmate 649, the most common adverse reactions (≥20%) in patients treated with opdivo in combination with chemotherapy (n=782) were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%). please see us full prescribing information for opdivo and yervoy. inrebic indication inrebic® (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (mf). important safety information boxed warning: encephalopathy including wernicke’s serious and fatal encephalopathy, including wernicke’s, has occurred in patients treated with inrebic. wernicke’s encephalopathy is a neurologic emergency. assess thiamine levels in all patients prior to starting inrebic, periodically during treatment, and as clinically indicated. do not start inrebic in patients with thiamine deficiency; replete thiamine prior to treatment initiation. if encephalopathy is suspected, immediately discontinue inrebic and initiate parenteral thiamine. monitor until symptoms resolve or improve and thiamine levels normalize. warnings and precautions encephalopathy, including wernicke’s: serious and fatal encephalopathy, including wernicke’s encephalopathy, has occurred in inrebic-treated patients. serious cases were reported in 1.3% (8/608) of patients treated with inrebic in clinical trials and 0.16% (1/608) of cases were fatal. wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (vitamin b1) deficiency. signs and symptoms of wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. assess thiamine levels in all patients prior to starting inrebic, periodically during treatment, and as clinically indicated. do not start inrebic in patients with thiamine deficiency; replete thiamine prior to treatment initiation. if encephalopathy is suspected, immediately discontinue inrebic and initiate parenteral thiamine. monitor until symptoms resolve or improve and thiamine levels normalize. anemia: new or worsening grade 3 anemia occurred in 34% of inrebic-treated patients. the median time to onset of the first grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. mean hemoglobin levels reached nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. red blood cell transfusions were received by 51% of inrebic-treated patients and permanent discontinuation of inrebic occurred due to anemia in 1% of patients. consider dose reduction for patients who become red blood cell transfusion dependent. thrombocytopenia: new or worsening grade ≥3 thrombocytopenia during the randomized treatment period occurred in 12% of inrebic-treated patients. the median time to onset of the first grade 3 thrombocytopenia was approximately 1 month; with 75% of cases occurring within 4 months. platelet transfusions were received by 3.1% of inrebic-treated patients. permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of inrebic-treated patients. obtain a complete blood count (cbc) at baseline, periodically during treatment, and as clinically indicated. for grade 3 thrombocytopenia with active bleeding or grade 4 thrombocytopenia, interrupt inrebic until resolved to less than or equal to grade 2 or baseline. restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated. gastrointestinal toxicity: gastrointestinal toxicities are the most frequent adverse reactions in inrebic-treated patients. during the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patients, and vomiting in 39% of patients. grade 3 diarrhea 5% and vomiting 3.1% occurred. the median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. consider providing appropriate prophylactic anti-emetic therapy (e.g., 5-ht3 receptor antagonists) during inrebic treatment. treat diarrhea with anti-diarrheal medications promptly at the first onset of symptoms. grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt inrebic until resolved to grade 1 or less or baseline. restart dose at 100 mg daily below the last given dose. monitor thiamine levels and replete as needed. hepatic toxicity: elevations of alt and ast (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with grade 3 or 4 in 1% and 0%, respectively, of inrebic-treated patients. the median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. for grade 3 or higher alt and/or ast elevations (greater than 5 × uln), interrupt inrebic dose until resolved to grade 1 or less or to baseline. restart dose at 100 mg daily below the last given dose. if re-occurrence of a grade 3 or higher elevation of alt/ast, discontinue treatment with inrebic. amylase and lipase elevation: grade 3 or higher amylase 2% and/or lipase 10% elevations developed in inrebic-treated patients. the median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. one patient developed pancreatitis in the fedratinib clinical development program (n=608) and pancreatitis resolved with treatment discontinuation. monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. for grade 3 or higher amylase and/or lipase elevations, interrupt inrebic until resolved to grade 1 or less or to baseline. restart dose at 100 mg daily below the last given dose. major adverse cardiac events (mace): another jak inhibitor has increased the risk of mace, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (compared to those treated with tnf blockers), a condition for which inrebic is not indicated. consider the benefits and risks of the individual patients prior to initiating or continuing therapy with inrebic, particularly in patients who are current or past smokers, or have other cardiovascular risk factors. patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur. thrombosis: another jak inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis in patients with rheumatoid arthritis (compared to those treated with tnf blockers), a condition for which inrebic is not indicated. in patients with mf treated with inrebic in clinical trials, the rates of thromboembolic events were similar in inrebic and placebo treated patients. patients with symptoms of thrombosis should be promptly evaluated and treated appropriately. secondary malignancies: another jak inhibitor has increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (nmsc) in patients with rheumatoid arthritis, a condition for which inrebic is not indicated. patients who are current or past smokers are at additional increased risk. consider the benefits and risks for the individual patient prior to initiating or continuing therapy with inrebic, particularly in patients with a known malignancy (other than a successfully treated nmsc), patients who develop a malignancy, and patients who are current or past smokers. adverse reactions the most common adverse reactions for inrebic treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received inrebic. adverse reactions requiring dosage interruption in >3% of patients who received inrebic included diarrhea and nausea. dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received inrebic. adverse reactions requiring dosage reduction in >2% of patients who received inrebic included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%). drug interactions coadministration of inrebic with a strong cyp3a4 inhibitor increases fedratinib exposure. increased exposure may increase the risk of adverse reactions. consider alternative therapies that do not strongly inhibit cyp3a4 activity. alternatively, reduce the dose of inrebic when administering with a strong cyp3a4 inhibitor. avoid inrebic with strong and moderate cyp3a4 inducers. avoid inrebic with dual cyp3a4 and cyp2c19 inhibitor. coadministration of inrebic with drugs that are cyp3a4 substrates, cyp2c19 substrates, or cyp2d6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. monitor for adverse reactions and adjust the dose of drugs that are cyp3a4, cyp2c19, or cyp2d6 substrates as necessary when coadministered with inrebic. pregnancy/lactation consider the benefits and risks of inrebic for the mother and possible risks to the fetus when prescribing inrebic to a pregnant woman. due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with inrebic, and for at least 1 month after the last dose. renal impairment reduce inrebic dose when administered to patients with severe renal impairment. no modification of the starting dose is recommended for patients with mild to moderate renal impairment. due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions. hepatic impairment avoid use of inrebic in patients with severe hepatic impairment. please see full prescribing information, including boxed warning, and summary of product characteristics for inrebic. abecma indication abecma (idecabtagene vicleucel) is a b-cell maturation antigen (bcma)-directed genetically modified autologous t cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 monoclonal antibody. important safety information boxed warning: cytokine release syndrome, neurologic toxicities, hlh/mas, and prolonged cytopenia cytokine release syndrome (crs), including fatal or life-threatening reactions, occurred in patients following treatment with abecma. do not administer abecma to patients with active infection or inflammatory disorders. treat severe or life-threatening crs with tocilizumab or tocilizumab and corticosteroids. neurologic toxicities, which may be severe or life-threatening, occurred following treatment with abecma, including concurrently with crs, after crs resolution, or in the absence of crs. monitor for neurologic events after treatment with abecma. provide supportive care and/or corticosteroids as needed. hemophagocytic lymphohistiocytosis/macrophage activation syndrome (hlh/mas) including fatal and life-threatening reactions, occurred in patients following treatment with abecma. hlh/mas can occur with crs or neurologic toxicities. prolonged cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with abecma. abecma is available only through a restricted program under a risk evaluation and mitigation strategy (rems) called the abecma rems. warnings and precautions: cytokine release syndrome (crs): crs, including fatal or life-threatening reactions, occurred following treatment with abecma in 85% (108/127) of patients. grade 3 or higher crs occurred in 9% (12/127) of patients, with grade 5 crs reported in one (0.8%) patient. the median time to onset of crs, any grade, was 1 day (range: 1 - 23 days) and the median duration of crs was 7 days (range: 1 - 63 days). the most common manifestations included pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and headache. grade 3 or higher events that may be associated with crs include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome (ards), atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and hlh/mas. identify crs based on clinical presentation. evaluate for and treat other causes of fever, hypoxia, and hypotension. crs has been reported to be associated with findings of hlh/mas, and the physiology of the syndromes may overlap. in patients with progressive symptoms of crs or refractory crs despite treatment, evaluate for evidence of hlh/mas. fifty four percent (68/127) of patients received tocilizumab (single dose: 35%; more than 1 dose: 18%). overall, 15% (19/127) of patients received at least 1 dose of corticosteroids for treatment of crs. all patients that received corticosteroids for crs received tocilizumab. ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of abecma. monitor patients at least daily for 7 days following abecma infusion at the rems-certified healthcare facility for signs or symptoms of crs and monitor patients for signs or symptoms of crs for at least 4 weeks after abecma infusion. at the first sign of crs, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. counsel patients to seek immediate medical attention should signs or symptoms of crs occur at any time. neurologic toxicities: neurologic toxicities, which may be severe or life-threatening, occurred following treatment with abecma in 28% (36/127) of patients receiving abecma, including grade 3 in 4% (5/127) of patients. one patient had ongoing grade 2 neurotoxicity at the time of death. two patients had ongoing grade 1 tremor at the time of data cutoff. the median time to onset of neurotoxicity was 2 days (range: 1 - 42 days). car t cell-associated neurotoxicity resolved in 92% (33/36) of patients with a median time to resolution of 5 days (range: 1 - 61 days). the median duration of neurotoxicity was 6 days (range: 1 - 578) in all patients including 3 patients with ongoing neurotoxicity. thirty-four patients with neurotoxicity had crs with onset in 3 patients before, 29 patients during, and 2 patients after crs. the most frequently reported manifestations of car t cell-associated neurotoxicity include encephalopathy, tremor, aphasia, and delirium. grade 4 neurotoxicity and cerebral edema in 1 patient, grade 3 myelitis, and grade 3 parkinsonism have been reported with abecma in another study in multiple myeloma. monitor patients at least daily for 7 days following abecma infusion at the rems-certified healthcare facility for signs or
