KENILWORTH (NJ) (dpa-AFX) - Japan's Astellas Pharma Inc. (ALPMY, ALPMY) and Seagen Inc. (SGEN) announced Tuesday positive topline results from the EV-103 trial or Cohort K for Padcev (enfortumab Vedotin-Ejfv) in combination with Merck's Keytruda (pembrolizumab) as a first-line treatment for advanced urothelial cancer.
In pre-market activity on Nasdaq, Seagen shares were gaining around 3.3 percent to trade at $178.50.
The companies said they plan to discuss results with regulatory authorities as they seek to develop a new first-line treatment combination for these patients.
The positive results were reported from the phase 1b/2 EV-103 clinical trial, also known as KEYNOTE-869, Cohort K evaluating PADCEV in combination with Merck's anti-PD-1 therapy KEYTRUDA as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer or la/mUC who are ineligible to receive cisplatin-based chemotherapy.
In patients treated with enfortumab vedotin and pembrolizumab, the results overall are generally consistent with previously reported efficacy and safety results of the EV-103 dose-escalation cohort and expansion Cohort A.
Additional Cohort K results will be reported at an upcoming scientific congress.
Astellas, Seagen and Merck are investigating enfortumab vedotin plus pembrolizumab as part of an extensive collaboration, which also includes three Phase 3 studies. The EV-302/KEYNOTE-A39 trial is intended to confirm these results, as well as EV-304/KEYNOTE-B15 and EV-303/KEYNOTE-905 are in muscle-invasive bladder cancer.
In February 2020, the U.S. Food and Drug Administration granted Breakthrough Therapy designation for enfortumab vedotin in combination with pembrolizumab for patients with unresectable la/mUC who are ineligible to receive cisplatin-based chemotherapy in the first-line setting.
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