(Add share price move, background)
June 24 A late-stage trial testing Bristol-Myers
Squibb Co's cancer immunotherapy nivolumab in advanced
melanoma patients was halted early after it was determined that
the drug was likely to prolong survival, the company said on
Bristol-Myers shares rose nearly 3 percent after the company
announced the survival benefit finding.
The 418-patient Phase III study, called CheckMate -066, was
testing nivolumab as an initial, or first line, therapy for
patients with advanced melanoma, the deadliest form of skin
An interim analysis performed by an independent
data-monitoring committee found evidence of superior overall
survival in patients receiving nivolumab compared with those who
received the chemotherapy dacarbazine, Bristol said. The
committee stopped the study early to allow the dacarbazine
patients to switch to the Bristol drug.
Nivolumab belongs to a new class of medicines called PD-1
inhibitors that have generated great excitement for their
ability to help the immune system recognize and attack cancer.
Analysts have forecast multibillion-dollar sales for the
drugs being developed by several companies once they gain
Merck & Co Inc, AstraZeneca Plc and Roche
Holding AG have similar drugs in development that have
shown great promise in treating melanoma and are also being
tested against lung, kidney, bladder and other cancers.
"The outcome of CheckMate -066 ... represents the first
well-controlled, randomized Phase III trial of an
investigational PD-1 checkpoint inhibitor to demonstrate an
overall survival benefit," Michael Giordano, Bristol's head of
oncology development, said in a statement.
Independent monitors routinely analyze data from blinded
trials at various points and can stop a study if a safety
problem arises or if the study drug is seen as likely to prove
clearly superior to the control medicine.
The duration of the survival benefit was not yet available.
Bristol said it plans to complete a full evaluation of the trial
data and work with researchers on a future presentation of the
Bristol-Myers shares rose to $49.58 in after-hours trading,
a 2.7 percent increase over their New York Stock Exchange close
(Reporting by Bill Berkrot; Editing by Steve Orlofsky and Lisa