Elahere® demonstrates overall survival benefit in the phase 3 mirasol trial in patients with frΑ-positive platinum-resistant ovarian cancer
Waltham, mass.--(business wire)--immunogen inc. (nasdaq: imgn), a leader in the expanding field of antibody-drug conjugates (adcs) for the treatment of cancer, today announced positive top-line data from the phase 3 confirmatory mirasol trial (gog 3045/engot ov-55) evaluating the safety and efficacy of elahere® (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (frΑ)-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy. based on these data, the company plans to submit a marketing authorization application (maa) in europe and a supplemental biologics license application (sbla) in the us for the conversion to a regular approval of elahere. "i believe the data from the confirmatory mirasol trial are practice-changing. they demonstrate elahere's superiority to chemotherapy based on all efficacy endpoints, in particular overall survival, and build on the clinical benefit of elahere previously reported in the soraya trial," said kathleen moore, associate director of clinical research and director of the oklahoma tset/sarah cannon phase i program, professor of the section of gynecologic oncology at the university of oklahoma and mirasol principal investigator. "last year's accelerated approval of elahere was a paradigm-shifting development in the treatment landscape for this disease and i am confident that, with the mirasol data, elahere has the potential to become the new standard of care for patients with frΑ-positive, platinum-resistant ovarian cancer. frΑ status is a 'must know' for all ovarian cancer patients and, for those with platinum-resistant disease who test positive, i believe elahere should be their first treatment option." mirasol (nct04209855) is a randomized phase 3 trial of elahere versus investigator's choice (ic) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). eligibility criteria include patients with platinum-resistant ovarian cancer whose tumors express high levels of frΑ, using the ventana folr1 assay, and who have been treated with up to three prior regimens. the primary endpoint of this trial is progression-free survival (pfs) by investigator assessment. key secondary endpoints include objective response rate (orr) and overall survival (os). key findings from mirasol mirasol enrolled 453 patients; 14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy. 62% of patients received prior bevacizumab; 55% received a prior parp inhibitor. as of the data cutoff on march 6, 2023, the median follow-up time for os was 13.1 months; 14% of patients on the elahere arm remained on study drug compared to 3% on the ic chemotherapy arm. elahere demonstrated a statistically significant and clinically meaningful improvement in os compared to ic chemotherapy. with 204 os events reported as of march 6, 2023, the median os was 16.46 months in the elahere arm, compared to 12.75 months in the ic chemotherapy arm, with a hazard ratio (hr) of 0.67, p=0.0046. this represents a 33% reduction in the risk of death in the elahere arm in comparison to the ic chemotherapy arm. elahere demonstrated a statistically significant and clinically meaningful improvement in pfs by investigator assessment compared to ic chemotherapy, with a hazard ratio of 0.65 (p1.5 uln). please see full prescribing information, including boxed warning for elahere. about immunogen immunogen is developing the next generation of antibody-drug conjugates (adcs) to improve outcomes for cancer patients. by generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. we call this our commitment to target a better now™. learn more about who we are, what we do, and how we do it at www.immunogen.com. elahere® is a trademark of immunogen, inc. forward-looking statements this press release includes forward-looking statements. these statements include, but are not limited to, immunogen's expectations related to the potential of elahere to become the standard of care in frΑ-positive ovarian cancer; the potential full approval of elahere in the us and expansion to europe, including the submission of a maa in europe and a sbla in the us anticipated in the second half 2023; the presentation of full mirasol dater later this year; and the company's business and product development strategies. various factors could cause immunogen's actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. factors that could cause future results to differ materially from such expectations include, but are not limited to: top-line data may change as more patient data become available and are subject to audit and verification procedures;the timing and outcome of the company's preclinical and clinical development processes; the results of the ongoing mirasol trial may not support full approval of elahere and, if so, additional studies may be required; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of preclinical studies, clinical trials, and regulatory processes; the timing and outcome of the company's anticipated interactions with regulatory authorities; the risk that the company may not be able to obtain adequate price and reimbursement for any approved products, including the potential for delays or additional difficulties for elahere in light of the fda granting accelerated approval; risks and uncertainties associated with the scale and duration of the covid-19 pandemic and the resulting impact on immunogen's industry and business; and other factors as set forth in the company's annual report on form 10-k filed with the securities and exchange commission on march 1, 2023, the company’s quarterly report on form 10-q filed with the securities and exchange commission on april 28, 2023, and other reports filed with the securities and exchange commission. the forward-looking statements in this press release speak only as of the date of this press release. immunogen undertakes no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by applicable law.
