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Bristol-Myers' Opdivo Meets Goals in Bladder Cancer Study

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Bristol Myers Squibb (BMY - Free Report) announced that the phase III study, CheckMate-274, on immuno-oncology drug, evaluating Opdivo, after surgery in patients with high-risk, muscle-invasive urothelial carcinoma was successful.

CheckMate-274 is a phase III randomized, double-blind, multi-center study, evaluating Opdivo compared with placebo in participants with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery.

The study met its primary endpoints of improving disease-free survival (DFS) versus placebo in all randomized patients as well as in patients whose tumor cells express PD-L1 ≥1% (programmed death-ligand 1).

Per the company, CheckMate -274 is the first and only phase III study in which immunotherapy has reduced the risk of relapse in the adjuvant setting for these patients.

The safety profile of Opdivo was consistent with previously reported studies in solid tumors.

More than 50% of patients with bladder cancer are likely to experience a recurrence after surgery and the disease results in deaths of 200,000 patients each year.  Hence, positive results from this study highlight the potential of Opdivo to become a new standard of care in the adjuvant setting, extending disease-free survival for post-surgery patients with muscle-invasive urothelial cancer without the use of chemotherapy.

The study will continue as planned to allow for future analyses of secondary endpoints, including overall survival and disease-specific survival.

With these positive results, Opdivo has now demonstrated improved efficacy in the adjuvant treatment of three tumor types — bladder cancer, melanoma and esophageal/gastroesophageal junction cancer.

Bristol-Myers’ shares have lost 8.5% in the year so far compared with the industry's decline of 0.9%.


We note that the drug is currently approved in many regions, including the United States, the EU and Japan, for several cancer indications. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents.

Earlier in the year, the FDA approved the combination of Opdivo and Yervoy for the lucrative indication of first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The approval not only opens an important treatment option for the affected patients but also presents an opportunity for Opdivo to gain market share.

Approval in additional indications should boost Opdivo sales, which were not impressive in the second quarter. Notably, the drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). Horizon Therapeutics (HZNP - Free Report) is a better-ranked stock in the biotech sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Horizon’s earnings per share estimates have increased 3 cents in the past seven days for 2020 and 6 cents for 2021.

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