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Astellas, Seagen complete enrollment in phase 1b/2 EV-103 trial of Padcev in combo with Keytruda to treat advanced urothelial cancer

Thursday, October 14, 2021, 16:00 Hrs  [IST]

Astellas Pharma Inc. and Seagen Inc. announced that patient enrollment was completed in Cohort K of the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869). The cohort is evaluating Padcev (enfortumab vedotin-ejfv) in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. Merck is known as MSD outside the United States and Canada.

Astellas Pharma Inc. and Seagen Inc. are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration.

"Completing enrollment in this study is an important step in investigating the potential for the combination of Padcev and Keytruda to treat metastatic urothelial cancer," said Roger Dansey, M.D., chief medical officer, Seagen. "If results of this study are compelling, we may have the opportunity to submit them to the FDA as part of an application for accelerated approval."

EV-103 is a multi-cohort, open-label, multicenter phase 1b/2 trial of Padcev alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive bladder cancer and in locally advanced or metastatic urothelial cancer in first- or second-line settings. Key outcome measures of EV-103 Cohort K are objective response rate (ORR) per blinded independent central review (BICR) using RECIST 1.1 and duration of response (DoR). The US Food and Drug Administration (FDA) granted Breakthrough Therapy designation in February 2020 for Padcev in combination with Keytruda for patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. The designation is based on results from the dose-escalation cohort and expansion cohort A of the EV-103 trial.

"The FDA's Breakthrough Therapy designation is based on preliminary data on the combination of Padcev and Keytruda," said Andrew Krivoshik, M.D., Ph.D., senior vice president and head of development therapeutic areas, Astellas. "Both Cohort K of EV-103 and our ongoing, broader phase 3 EV-302 study are evaluating this platinum-free combination in patients with previously untreated advanced urothelial cancers." EV-302 is also known as KEYNOTE-A39.

It is estimated that approximately 83,730 people in the US will be diagnosed with bladder cancer in 2021. Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. Globally, approximately 573,000 new cases of bladder cancer and 212,000 deaths are reported annually.

Padcev is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of Padcev is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).

Astellas and Seagen entered a clinical collaboration agreement with Merck to evaluate the combination of Astellas' and Seagen's Padcev (enfortumab vedotin-ejfv) and Merck's Keytruda (pembrolizumab), in patients with previously untreated metastatic urothelial cancer. Keytruda is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Seagen Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives.


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