Merck soars, Bristol-Myers tumbles on Opdivo fail in first-line NSCLC

Bristol-Myers Squibb ($BMY) and Merck ($MRK) have hit a sharp turn in the road in their PD-1 immune checkpoint inhibitor race. After strong positive data from Merck in June for its Keytruda to treat first-line advanced non-small cell lung cancer (NSCLC), now BMS has revealed that its own Opdivo did not meet the primary endpoint in a Phase III trial in the same indication.

Merck quickly gained about 10%, while Bristol-Myers fell almost 20% in pre-market trading after BMS said its Opdivo (nivolumab) did not meet the primary endpoint of progression-free survival (PFS) in untreated, advanced NSCLC patients whose tumors expressed PD-L1 of at least 5%.

BMS said it will complete a full evaluation of its study, CheckMate-026, and conduct a future presentation of the results. It expects to proceed with an ongoing Phase III study, CheckMate-227 testing Opdivo and Yervoy in first-line NSCLC.

“Opdivo has become a foundational treatment that is transforming cancer care across multiple tumor types,” said Bristol-Myers CEO Giovanni Caforio in a statement. “While we are disappointed CheckMate-026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase III CheckMate-227 study exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.”

In its Keytruda Phase III trial, Merck’s study population was a bit different--in the same first-line NSCLC indication but specifically in patients with high-level PD-LI expression of 50% or more. In its data, Merck not only met the primary endpoint of PFS, but also the often more difficult to meet secondary endpoint of overall survival (OS).

Opdivo was the first approved PD-1 immune checkpoint inhibitor on July 24. Its approved indications include several in melanoma, metastatic NSCLC with progression on or after platinum-based chemotherapy, advanced renal cell carcinoma (RCC) in patients with prior anti-angiogenic therapy and classical Hodgkin lymphoma (cHL) patients who have relapsed or progressed after treatment.

Bristol-Myers shed roughly $20 billion in market cap in early trading on the news--pushing its valuation down to about $100 billion. Merck added about $16 billion to more than $175 billion.

- here is the release

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