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Bristol Myers (BMY) Phase III CheckMate -901 Study Disappoints logo 5/17/2022

Bristol Myers Squibb BMY has announced disappointing results from the phase III CheckMate -901 study.

CheckMate -901 is a phase III randomized, open-label study evaluating Opdivo in combination with Yervoy (primary study) or Opdivo in combination with chemotherapy (sub-study) compared to standard-of-care chemotherapy alone in patients with untreated unresectable or metastatic urothelial cancer.

The primary study failed to meet the primary endpoint of overall survival (OS) in patients whose tumor cells express PD-L1 ≥1% at the final analysis.

Nevertheless, an independent Data Monitoring Committee recommended that the trial continues to assess other primary and secondary endpoints. At this point, Bristol Myers remains blinded to the data.

The CheckMate-901 study is also assessing the combination in patients with unresectable or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy.  A sub-study of CheckMate-901 with pivotal intent is evaluating Opdivo in combination with chemotherapy compared to chemotherapy alone in patients who are eligible for cisplatin-based chemotherapy.

Both the primary study and sub-study are ongoing, and the company will report results for these additional components of the study when available.

The combination has shown significant improvements in OS in six phase III in five tumors to date: non-small cell lung cancer, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma. In addition, Opdivo has shown clinical benefit in second-line metastatic urothelial carcinoma and adjuvant muscle-invasive urothelial carcinoma.

The performance of the immuno-oncology drug Opdivo, approved for multiple cancer indications, has been solid of late. Opdivo is one of the top revenue generators for BMY and the continued label expansion of the drug for additional indications should further boost its growth potential.

Shares of Bristol Myers have rallied 23.4% year to date against the industry’s decline of 13.9%.

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The FDA recently approved a new, first-in-class, fixed-dose combination of Opdivo and relatlimab (novel LAG-3-blocking antibody) administered as a single intravenous infusion for the treatment of adult and pediatric patients aged 12 years and above with unresectable or metastatic melanoma (a kind of skin cancer). The drug is approved under the brand name Opdualag.

Approval of these new drugs adds a revenue stream, which should bolster growth in the coming quarters.

The FDA also approved cardiovascular drug Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.

However, competition is stiff for Opdivo from the likes of Merck’s MRK blockbuster drug Keytruda. Keytruda, approved for various oncology indications, is the key driver for MRK.

Continued label expansions of the drug boosted Merck’s top line.

Bristol Myers currently carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks are Alkermes ALKS and Geron Corporation GERN. While Alkermes sports a Zacks Rank #1 (Strong Buy), Geron has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.

Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.


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