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Seattle Genetics, Inc. SGEN along with Japanese partner Astellas Pharma, Inc announced positive overall survival data from the global phase III EV-301 study, which is evaluating their antibody-drug conjugate Padcev (enfortumab vedotin-ejfv) for treating locally advanced/metastatic urothelial cancer or bladder cancer in adult patients who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
Notably, in December 2019, the FDA granted 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 objective response rate (ORR) data from the single-arm phase II EV-201 study.
Notably, EV-301 is a confirmatory study to get the accelerated approval converted to a regular nod in the United States.
Data from the EV-301 study showed that treatment with Padcev significantly improved the overall survival (OS) rate with a 30% reduction in death risk compared to chemotherapy. Moreover, Padcev substantially bettered progression-free survival (PFS), which was the secondary endpoint with 39% reduction in the risk of disease progression or death.
Per the press release, results from the EV-301 study were reviewed by an independent Data Monitoring Committee following a planned interim analysis and the same was stopped prematurely owing to positive results.
Shares of Seattle Genetics have rallied 53.7% so far this year compared with the industry’s increase of 2.7%.
Padcev is Seattle Genetics’ second drug to have been approved by the FDA. The drug generated sales worth $91.6 million in the first six months of 2020. Several studies on Padcev are currently ongoing.
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 Seattle Genetics, 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.
Zacks Rank & Stocks to Consider
Seattle Genetics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Emergent BioSolutions Inc. EBS and Horizon Therapeutics Public Limited Company HZNP, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have been revised 55.5% and 37.3% upward for 2020 and 2021 each over the past 60 days. The stock has skyrocketed 93.1% year to date.
Horizon’s earnings estimates have been revised 56.3% and 55.1% upward for 2020 and 2021, respectively, over the past 60 days. The stock has soared 92.5% year to date.
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