Seattle Genetics, Inc. (SGEN - Free Report) and Astellas Pharma Inc announced the initiation of a phase II study-EV-201 of enfortumab vedotin. The study will evaluate patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy.
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) to target Nectin-4, a cell adhesion molecule which is expressed on many solid tumors.
Seattle Genetics’ shares have underperformed the industry year to date. The stock has surged 9.4% compared with the industry’s gain of 14.3%.
The study will evaluate the antitumor activity and safety of enfortumab vedotin in order to get the approval of the FDA. The study will enroll about 120 patients and enfortumab vedotin will be administered three of every four weeks for the duration of treatment. The primary endpoint of the study is confirmed objective response rate (ORR), per independent review. The secondary endpoints include assessments of overall survival, progression free-survival, safety and tolerability.
The company will move ahead with the EV-201 study based on the results of its ongoing phase I study. The ongoing phase I study is assessing the safety and anti-tumor activity of enfortumab vedotin at escalating doses of 0.5 to 1.25 milligrams per kilogram (mg/kg), weekly for three of every four week cycles. The company in June 2017 announced updated data from 81 patients who were diagnosed with mUC and with a median age of 67 years. Of these patients, 46% were previously treated with checkpoint inhibitor (CPIs) and 95% had undergone treatment with a platinum-based chemotherapy. The results showed positive antitumor activity and a well-tolerated safety profile in patients with heavily pretreated metastatic urothelial cancer.
The treatment options for metastatic urothelial cancers are limited for those patients who do not respond to chemotherapy and checkpoint inhibitors. There are no therapies approved by the FDA for patients who progress following CPI treatment. Thus, we see that there are a number of companies evaluating candidates for the treatment of locally advanced or metastatic urothelial cancer.
Last month, Merck & Co., Inc (MRK - Free Report) announced that its anti-PD-1 therapy, Keytruda received approval from the European Commission (EC) for the first- and second-line treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.
Keytruda has been approved as a first-line therapy for patients who cannot receive standard of care chemotherapy containing cisplatin. Keytruda was also approved as a second-line treatment for patients who have been previously treated with platinum-containing chemotherapy.
In May 2017, Eli Lilly and Company (LLY - Free Report) also announced positive results from a phase III study, RANGE, evaluating its oncology drug, Cyramza (ramucirumab), for expanded use in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma. The study met its primary end-points and demonstrated an improved progression-free survival (PFS) in patients with the given indication.
Zacks Rank & Stock to Consider
Currently, Seattle Genetics carries a Zacks Rank #2 (Buy). Another top-ranked stock in the health care sector includes Bayer Aktiengesellschaft (BAYRY - Free Report) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bayer’s earnings per share estimates have moved up from $2.17 to $2.24 for 2017 and from $2.37 to $2.39 for 2018, in the last 60 days. The company pulled off positive earnings surprises in three of the trailing four quarters, the average beat being 10.10%. The share price of the company has increased 27.9% year to date.
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