Seattle Genetics, Inc. SGEN along with Japanese partner Astellas Pharma, Inc announced encouraging initial results from the phase I EV-103 study on its investigational agent enfortumab vedotin. The candidate is being evaluated in combination with Merck’s MRK PD-1/L1 inhibitor Keytruda (pembrolizumab) 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 an encouraging clinical activity in first-line setting. The study evaluated 45 patients.
Data from the study showed that patients treated with the combo of enfortumab vedotin and Keytruda achieved a confirmed objective response rate (ORR) of 71% while the complete response (CR) rate was 13% and 58% of patients had a partial response. Importantly, the combo shrank tumors in the majority of the given patient population.
The data was presented at the European Society for Medical Oncology 2019 Congress held in Spain.
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule expressed in many solid tumors.
Shares of Seattle Genetics rallied 12.4% on Monday following the above news. In fact so far this year, the stock has surged 50.7% versus the industry’s decrease of 6.2%.
We remind investors that last month, the FDA accepted the biologics license application (BLA) for enfortumab vedotin under a priority review for the treatment of patients with advanced/metastatic urothelial cancer, having received both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy. A decision from the regulatory body is expected on Mar 15, 2020.
The BLA was based on data from the first cohort of the phase II EV-201 study on enfortumab vedotin.
In a separate press release, Seattle Genetics presented initial data from the single arm phase II MOUNTAINEER study on its investigational agent tucatinib.
The study evaluated tucatinib in combination with Roche’s RHHBY Herceptin (trastuzumab) for treating patients with HER2-positive RAS wild-type metastatic colorectal cancer, who have already received treatment with first and second-line standard-of-care therapies. The combo regime was well tolerated and demonstrated an encouraging antitumor activity.
Zacks Rank & Stock to Consider
Seattle Genetics currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Exelixis, Inc. EXEL, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Exelixis’ earnings estimates have been revised 3.4% upward for 2019 and 4.8% for 2020 over the past 60 days.
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