Seattle Genetics, Inc. SGEN announced an update on the phase Ib/II EV-103 study evaluating Padcev (enfortumab vedotin-ejfv) in combination with Merck’s MRK PD-1/L1 inhibitor Keytruda (pembrolizumab) for addressing patients with unresectable locally advanced/metastatic urothelial cancer who are not able to receive cisplatin-based chemotherapy in the first-line setting.
Following discussion with the FDA authorities, management said that data from the cohort K as well as other outcomes from the EV-103 study on the Padcev combo could potentially support registration under accelerated approval regulations in the United States.
Shares of Seattle Genetics were up 6.7% following the above announcement on Thursday. In fact, the stock has increased 3.9% so far this year against the industry’s decline of 11.3%.
The multi-cohort, open-label EV-103 study is evaluating the safety, tolerability and efficacy of Padcev as a monotherapy or in combination for muscle invasive urothelial cancer and in locally advanced/metastatic urothelial cancer in the first- or second-line settings.
We remind investors that in December 2019, the FDA granted accelerated approval to Padcev for the treatment of patients with advanced/metastatic urothelial cancer, who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy. Following this nod, Padcev became the first FDA-approved drug for treating the given patient population.
Padcev is an antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule expressed in many solid tumors. Seattle Genetics is developing Padcev in collaboration with Japanese partner Astellas Pharma, Inc.
Notably, in February 2020, Seattle Genetics announced updated results from the phase Ib/II EV-103 study on Padcev in combination with Keytruda for addressing previously-untreated patients with locally advanced/metastatic urothelial cancer, who are not eligible for cisplatin-based chemotherapy. The combo has been granted a Breakthrough Therapy designation by the FDA in the first-line setting.
In January this year, both Seattle Genetics and Astellas along with Merck initiated the phase III EV-302 study on the combination of Padcev and Keytruda with or without chemotherapy compared to chemotherapy alone for treating patients with previously-untreated metastatic urothelial cancer.
Per the company, data from the EV-302 study is likely to support global registrations and potentially serve as a confirmatory study if accelerated approval is granted to Padcev combo based on results from the EV-103 study.
Zacks Rank & Stocks to Consider
Seattle Genetics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Acorda Therapeutics, Inc. ACOR and Regeneron Pharmaceuticals, Inc. REGN, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have been narrowed 8.8% for 2020 and 11.1% for 2021 over the past 60 days.
Regeneron’s earnings estimates have been revised 5.6% upward for 2020 and 7.8% upward for 2021 over the past 60 days. The stock has rallied 32.9% year to date.
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