Seattle Genetics, Inc. SGEN along with Japanese partner Astellas Pharma, Inc announced positive top-line 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.
Both the companies plan to submit a biologics license application (BLA) for enfortumab vedotin to the FDA later this year.
Results from this study demonstrated a 44% objective response rate (ORR), per blinded independent central review. Moreover, the duration of response was similar to that of the previously reported data from phase I EV-101 study. The companies plan to present this data at an upcoming medical meeting.
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule that is expressed in many solid tumors.
We would like to remind investors that, in 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 the 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 potential approval of the candidate. The companies continue to evaluate EV combined with Merck’s MRK Keytruda in first-line setting.
Notably, Enfortumab vedotin was granted Breakthrough Therapy designation by the FDA for the given indication in March 2018.
Shares of Seattle Genetics have rallied 26.8% so far this year, outperforming the industry’s increase of 9.6%.
Apart from enfortumab vedotin, pipeline candidates in Seattle Genetics’ portfolio include tisotumab vedotin and SEA-BCMA. The company along with Danish company, Genmab A/S GNMSF is evaluating tisotumab vedotin in the pivotal innovaTV 204 study for the treatment of patients with recurrent/metastatic cervical cancer whose disease have relapsed or progressed after standard of care treatment. Both the companies expect to complete enrollment in the study by mid-2019.
Last November, Seattle Genetics initiated dosing in the phase I study on pipeline candidate, SEA-BCMA. The early-stage candidate is currently being evaluated for the treatment of patients with relapsed or refractory multiple myeloma (MM).
Zacks Rank & Key Pick
Seattle Genetics currently carries a Zacks Rank #5 (Strong Sell).
A better-ranked stock in the healthcare sector is Celgene Corp. CELG, which has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings estimates have been revised 3.5% upward for 2019 and 3.3% for 2020 over the past 60 days. The stock has surged 36.4% in the year so far.
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