Seattle Genetics, Inc. SGEN along with Japanese partner Astellas Pharma, Inc announced that it has inked a collaboration agreement with pharma giant Merck MRK to begin a phase III study for evaluating the combination of their antibody-drug conjugate enfortumab vedotin and the latter’s PD-1/L1 inhibitor Keytruda (pembrolizumab) to address patients with previously untreated metastatic urothelial cancer.
Per the agreement, the three companies will initiate a registrational phase III study to evaluate the efficacy of the enfortumab vedotin plus Keytruda combo in the above-mentioned patient population. The study, which will be led by Seattle Genetics, is expected to being in the first half of 2020. It is likely to support global registrations of enfortumab vedotin.
In September 2019, Seattle Genetics and Astellas released encouraging initial results from the phase I EV-103 study on enfortumab vedotin. The candidate is being evaluated in combination with Keytruda for addressing previously untreated patients with locally advanced/metastatic urothelial cancer, who are not eligible for cisplatin-based chemotherapy.
The platinum-free combination of enfortumab vedotin plus Keytruda met the outcome measures for safety and demonstrated a favorable clinical activity in first-line setting.
Shares of Seattle Genetics have skyrocketed 106.6% so far this year, outperforming the industry’s increase of 5.4%.
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We remind investors that in the same month, the FDA accepted the biologics license application (BLA) for enfortumab vedotin under a priority review. Seattle Genetics along with Astellas is seeking approval of the candidate 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. A decision from the regulatory body is expected on Mar 15, 2020.
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule, expressed in many solid tumors. If approved, the candidate will reduce the company’s heavy dependence on its sole marketed drug Adcetris.
Zacks Rank & Stocks to Consider
Seattle Genetics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Anika Therapeutics Inc. ANIK and Vertex Pharmaceuticals Incorporated VRTX, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 68.3% so far this year.
Vertex’s earnings estimates have been revised 5% upward for 2019 and 10.6% for 2020 over the past 60 days. The stock has surged 33.2% year to date.
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