Bristol Myers: Opdivo Failed to Meet Endpoint in Key Lung Cancer Study--3rd Update
August 05 2016 - 10:36AM
Dow Jones News
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 17% to $62.21 in early trading,
erasing roughly $22 billion of the company's market value and
nearly all of the stock's gains since mid-March.
Meanwhile, shares of Merck & Co. rose 5.6% as the result
suggests 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 high-profile 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.
Opdivo's failure to meet the endpoint comes as a surprise after
cancer-immunotherapy drugs put together a remarkable string of
successes against a variety of tumors. The failure is challenging
assumptions about Bristol Myers's dominance in lung cancer, which
is seen as the biggest market for immuno-oncology.
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.
Leerink analysts said they had spoken with Bristol management,
who were "surprised and disappointed" by the trial. "There appears
to be no silver lining," Leerink said.
Opdivo and Keytruda are options for certain patients with
non-small-cell lung cancer, which accounts for about 85% to 90% of
all lung-cancer cases. The National Cancer Institute estimates
224,390 Americans will be diagnosed with lung cancer this year, and
158,080 will die from it.
Opdivo, launched in late 2014 to treat skin cancer, is approved
for use in patients with melanoma, metastatic non-small cell lung
cancer, advanced renal cell carcinoma and relapsed classical
Hodgkin lymphoma.
Leerink 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.
Sales of Keytruda nearly tripled in Merck's latest quarter to
$314 million.
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
1.2% in early trading.
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
August 05, 2016 10:21 ET (14:21 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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