Seattle Genetics and Astellas announce positive top-line results from enfortumab vedotin cancer trial.
M2 PHARMA-March 29, 2019-Seattle Genetics and Astellas announce positive top-line results from enfortumab vedotin cancer trial
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US-based biotechnology company, Seattle Genetics Inc (Nasdaq:SGEN) and Japan-based pharmaceutical company, Astellas Pharma Inc (TSE: 4503), yesterday announced positive top-line results from the first cohort of patients in a pivotal phase 2 single-arm clinical trial known as EV-201.
The cohort is evaluating enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received previous treatment with both platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44% objective response rate (ORR) per blinded independent central review. The duration of response was consistent with that recently reported in the previous phase 1 study (EV-101). The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. The data will be submitted for presentation at an upcoming medical meeting.
Based on preliminary results from a phase 1 trial (EV-101), enfortumab vedotin was granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following treatment with a PD-1 or PD-L1 inhibitor.
The companies plan to submit a Biologics License Application (BLA) to the FDA later this year based on the results from the EV-201 trial (cohort 1). A global, randomised phase 3 clinical trial (EV-301) is ongoing and intended to support global registration as well as to serve as the confirmatory randomised trial for enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
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|Date:||Mar 29, 2019|
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