Bristol-Myers Squibb Company BMY suffered a setback as a late-stage study evaluating its blockbuster immuno-oncology drug Opdivo for the treatment of malignant brain tumor failed to meet its primary endpoint.
The phase III randomized, multi-center study CheckMate -548 is evaluating the addition of Opdivo to the current standard of care (Temodal and radiation therapy) compared to the standard of care alone in patients with newly diagnosed glioblastoma multiforme (GBM) that is O6-methylguanine-DNA methyltransferase (MGMT)-methylated.
However, the study did not meet the primary endpoint of progression-free survival (PFS) per blinded independent central review (BICR).
Nevertheless, the data monitoring committee recommended that the study continue as planned to allow the other primary endpoint, overall survival (OS), is yet to mature. The company remains blinded to all study data. The secondary endpoints are investigator assessed PFS, and OS rate up to two years.
Earlier, the phase III CheckMate-498 trial evaluating Opdivo plus radiation compared to temozolomide plus radiation in patients with newly diagnosed O6- MGMT-unmethylated GBM missed its primary goal of overall survival at final analysis.
Bristol-Myers’ shares have decreased 6.7% in the year so far, wider than the industry’s decline of 0.6%.
Meanwhile, Karyopharm Therapeutics KPTI is also evaluating Xpovio for the treatment of glioblastoma.
Opdivo is Bristol-Myers’ primary driver. It is currently approved in the United States, the EU, Japan and across other countries for several cancer indications. The company is working on expanding the label of Opdivo further.
However, the drug faces stiff competition and has endured debacles of late. It confronts rivalry from Merck’s MRK PD-L1 inhibitor Keytruda. Additionally, a close contest is on the rise in this category with the presence of Roche’s RHHBY Tecentriq. Both Keytruda and Tecentriq are approved for the first-line non-small cell lung cancer (NSCLC), which has the largest patient population among all cancer indications.
We remind investors that the part 1a of the phase III Checkmate-227 study evaluating Opdivo combined with low-dose Yervoy compared to chemotherapy only, succeeds in meeting the co-primary endpoint of overall survival in first-line NSCLC patients whose tumors express PD-L1 ≥1%. However, part 2 of the study evaluating Opdivo plus chemotherapy compared to chemotherapy alone was unable to meet its primary endpoint of overall survival in first-line non-squamous NSCLC patients, regardless of PD-L1 status.
Bristol-Myers currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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