Seattle Genetics, Inc. SGEN along with Japanese partner Astellas Pharma, Inc announced positive results from the first cohort of the phase II EV-201 study on enfortumab vedotin. The candidate is being evaluated in the pivotal study for the treatment of patients with advanced/metastatic urothelial cancer, who were previously treated with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
Data from the study showed that enfortumab vedotin rapidly shrank tumors, having achieved an objective response rate (ORR) of 44% in majority of the patients while complete responses (CR) were observed in 12% of the given subject population. The median duration of tumor response was 7.6 months.
The company presented this data at the annual meeting of the American Society of Clinical Oncology (ASCO) held in Chicago.
In the study, the responses observed were similar for patients, who had experienced worst prognosis including those whose disease had spread to the liver, having undergone three or more previous lines of therapy and for those, who did not respond to treatment with Merck’s MRK PD-1/L1 inhibitor, Keytruda.
Shares of Seattle Genetics were up almost 4.3% following the news on Monday. In fact, the stock has rallied 22.1% so far this year against the industry’s dip of 1.9%.
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule, that is expressed in many solid tumors. Both Seattle Genetics and Astellas plan to submit a biologics license application (BLA) for enfortumabvedotin to the FDA later this year.
We would like to remind investors that last July 2018, Seattle Genetics and Astellas initiated the phase III EV-301 study on enfortumab vedotin in patients with advanced urothelial cancer, who previously received both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy. Both companies also completed the cohort enrollment in EV-201 study for the same.
The phase III EV-301 study will support the regulatory filing for a potential approval of the candidate. The companies continue to evaluate enfortumab vedotin combined with Merck’s Keytruda in first-line setting.
Notably, Enfortumab vedotin was granted a Breakthrough Therapy designation by the FDA for the given indication last March.
Meanwhile, Seattle Genetics also presented three-year follow up data from the phase III ECHELON-1 and ECHELON-2 studies at the annual meeting of ASCO. The frontline phase III ECHELON-1 study compared Adcetris plus (Adriamycin, vinblastine and dacarbazine) AVD with ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) for treating patients with stage III/IV frontline classical Hodgkin lymphoma. The study continues to demonstrate Adcetris’ superior clinical activity in combination with chemotherapy when compared to ABVD for treating frontline Hodgkin lymphoma.
Zacks Rank & Stocks to Consider
Seattle Genetics currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the healthcare sector include Acorda Therapeutics, Inc. ACOR and Repligen Corp. RGEN, 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 6.5% for 2019 and 6.9% for 2020 over the past 60 days.
Repligen’s earnings estimates have been revised 13.3% upward for 2019 and 12% for 2020 over the past 60 days. The stock has surged 30.6% year to date.
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