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Seagen Inc. SGEN along with Japanese partner Astellas Pharma, Inc announced positive top-line data from the second cohort of the pivotal phase II EV-201 study, which is evaluating their antibody-drug conjugate Padcev (enfortumab vedotin-ejfv). The drug is being studied for treating locally advanced/metastatic urothelial cancer or bladder cancer in patients who were previously treated with a PD-1/L1 inhibitor, having not received a platinum-containing chemotherapy and are ineligible for cisplatin.
Data from the single arm EV-201 study showed that treatment with Padcev led to a 52% objective response rate (ORR) per the blinded independent central review while the median duration of response was 10.9 months in the given patient population.
Per the company, the encouraging new data from the EV-201 study might form the basis of a regulatory application to extend the use of Padcev for patients whose cancer progressed following immunotherapy and are ineligible for cisplatin in the United States. The partners plan to present data from the second cohort of the EV-201 study at an upcoming scientific conference.
Shares of Seagen were up 2.5% in response to the above news on Monday. In fact, the stock has rallied 80.2% so far this year compared with the industry’s increase of 1.9%.
Notably, in December 2019, the FDA granted an accelerated approval to Padcev for the treatment of patients with advanced/metastatic urothelial cancer, who had earlier received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy. This nod was on the basis of ORR data from the first cohort of the single-arm phase II EV-201 study.
Padcev generated sales worth $91.6 million in the first six months of 2020. Several studies on Padcev are currently ongoing.
Meanwhile, the phase Ib/II EV-103 study is evaluating Padcev in combination with Merck’s MRK PD-1/L1 inhibitor Keytruda (pembrolizumab) for addressing patients with unresectable locally advanced/metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. The expansion is being conducted under a clinical trial collaboration and supply agreement among Seagen, Astellas and Merck.
Padcev is also being evaluated as a monotherapy in the phase II EV-202 study for treating a range of solid tumors. A potential label expansion of the drug will boost its sales in the future quarters.
We remind investors that in October 2020, Seattle Genetics decided to switch over to its new corporate name Seagen Inc.
Zacks Rank & Stocks to Consider
Seagen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include AVEO Pharmaceuticals, Inc. AVEO and Immunomedics, Inc. IMMU, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AVEO’s loss per share estimates have narrowed 25.6% for 2020 and 28.6% for 2021 over the past 60 days. The stock has increased 3.3% year to date.
Immunomedics’ loss per share estimates have narrowed 0.9% for 2020 and 5.5% for 2021 over the past 60 days. The stock has skyrocketed 306.9% year to date.
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