Seattle genetics, inc. and astellas pharma inc. announce results from phase 1 trial of investigational agent enfortumab vedotin in combination with immune therapy pembrolizumab as first-line treatment for advanced bladder cancer

Seattle genetics, inc. and astellas pharma inc. announced initial results from the phase 1 clinical trial ev-103. forty-five patients were evaluated for safety with the combination of the investigational agent enfortumab vedotin and the immune therapy pembrolizumab in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy. the study met outcome measures for safety and exhibited encouraging clinical activity for this platinum-free combination in a first-line setting. the data will be presented during an oral session today at the european society for medical oncology (esmo) 2019 congress in barcelona, spain (abstract #901o). enfortumab vedotin is a first-in-class antibody drug conjugate (adc) that targets nectin-4, a protein present on almost all urothelial tumor cells and associated with cancer formation. fifty-one percent of patients (23/45) had an adverse event greater than or equal to grade 3. among these events, an increase in lipase was the most frequent (13%; 6/45). four patients (9%) discontinued treatment due to treatment-related adverse events, most commonly peripheral sensory neuropathy. there was one death deemed to be treatment-related by the investigator attributed to multiple organ dysfunction syndrome.
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