Bristol Myers: Opdivo Failed to Meet Endpoint in Key Lung Cancer Study--Update

By Anne Steele 

Bristol-Myers Squibb Co. said a trial investigating its blockbuster cancer drug Opdivo as a therapy for advanced non-small cell lung cancer failed to meet its primary endpoint.

Shares in the company dropped 19% to $61 in premarket trading.

Meanwhile, shares of Merck & Co. rose 11% as the results suggest sales of its rival immunotherapy cancer drug Keytruda could benefit from the trial's failure. In June, Merck's similar trial investigating the use of Keyruda for the same condition met its primary endpoint. The drug prolonged survival versus chemotherapy, though Merck hasn't released full details yet.

Bristol said the trial, named CheckMate -026, didn't show progression-free survival in patients with previously untreated advanced non-small cell lung cancer.

"While we are disappointed CheckMate -026 didn't meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, " said Bristol-Myers Chief Executive Dr. Giovanni Caforio.

Bristol was the first to bring to market an immunotherapy, which aims to fight cancer by unshackling the body's immune system. Sales of Opdivo -- its newest immunotherapy -- rose to $840 million in the most recent quarter, up $718 million from a year earlier and accounting for much of Bristol's revenue gains in the quarter.

Ahead of Bristol's Friday report, Leerink analysts had said a CheckMate -026 failure could push Merck's immuneoncology sales to $5 billion in 2026 -- compared with a $3.5 billion base estimate.

"We'd expect Merck to gain significant traction in the overall market," Leerink said.

Keytruda, an infused drug, was approved in 2014 for the treatment of melanoma. Then, it was a new type of immunotherapy in a category of treatments that harness the immune system to fight cancer. In October, it was cleared for use in patients with non-small-cell lung cancer-the most common form of lung cancer, whose tumors contain a certain level of a protein known as PD-L1, and whose disease continued to worsen after the patient received chemotherapy or other drugs.

In April, the U.S. Food and Drug Administration accepted Merck's supplemental biologics license application for Keytruda's use in patients with head and neck cancer. The FDA granted pembrolizumab, or Keytruda, priority review status with a target action date of Aug. 9.

AstraZeneca PLC, too, could benefit from Bristol's trial failure. Leerink suggests as market share for the drugmaker's durvalumab and tremelimumab could improve. AstraZeneca shares rose 3.6% premarket to $35.52.

Write to Anne Steele at [e-mail]

(END) Dow Jones Newswires

August 05, 2016 09:24 ET (13:24 GMT)

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