Bristol Myers: Opdivo Failed to Meet Endpoint in Key Lung Cancer Study
August 05 2016 - 9:12AM
Dow Jones News
By Anne Steele
Bristol-Myers Squibb Co. said results for 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 17% to $62.60 in premarket
trading.
Meanwhile, shares of Merck & Co. rose 10% 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.
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.
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.
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
August 05, 2016 08:57 ET (12:57 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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