Shares in Bristol-Myers Squibb plunged as much as 23 percent Friday after the company announced that a Phase III study of the PD-1 inhibitor Opdivo (nivolumab) in patients with previously untreated advanced non-small-cell lung cancer (NSCLC) failed to hit its main goal of progression-free survival (PFS). Meanwhile, shares of Merck & Co., which markets the similar drug Keytruda (pembrolizumab), rose as much as 11 percent on the news.
The CheckMate-026 study randomised 541 patients with advanced NSCLC to treatment with Opdivo or chemotherapy until disease progression, unacceptable toxicity or the completion of six cycles. The primary endpoint of PFS was assessed by the Independent Radiology Review Committee in patients whose tumours expressed PD-L1 on at least 5 percent of cells.
In June, Merck announced data from the Phase III KEYNOTE-024 trial illustrating that Keytruda monotherapy was associated with superior PFS and overall survival in patients with previously untreated advanced NSCLC. However, the study included patients whose tumours expressed PD-L1 on at least 50 percent of cells.
Opdivo was first approved in 2014 to treat melanoma, and is also authorised for use in patients with metastatic non-small-cell lung cancer, advanced renal cell carcinoma and relapsed classical Hodgkin lymphoma. Last month, Bristol-Myers Squibb disclosed that second-quarter sales of the product reached $840 million, up from $122 million in the year-ago period. Revenue from Opdivo has been projected to rise to $7.7 billion by 2018.
Commenting on the CheckMate-026 study results, Evercore analyst Mark Schoenebaum remarked "this is a major surprise, possibly the biggest clinical surprise of my career." Meanwhile, Leerink analysts said they had spoken with Bristol-Myers Squibb management, who were "surprised and disappointed" by the trial, noting "there appears to be no silver lining." Leerink analysts had previously predicted that failure in the CheckMate-026 trial could boost sales of Merck's immunotherapies to $5 billion by 2026, versus estimates of $3.5 billion. "We'd expect Merck to gain significant traction in the overall market," the analysts said, adding that the market opportunities for AstraZeneca's investigational therapies durvalumab and tremelimumab could also improve based on the study failure.
For related analysis, see KOL Views: FirstWord discusses the future of PD-(L)1 therapy in first-line NSCLC with Jared Weiss –section chief of thoracic and head/neck oncology, University of North Carolina School of Medicine, Chapel Hill NC.
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