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 The data has been keenly awaited since this is the first
presentation of results from a pivotal Phase III clinical trial of a
promising new class of drugs designed to help the body's own immune
system fight cancer.
In the study, involving people with advanced melanoma, 32 percent of
patients saw their tumors shrink when given Opdivo against 11
percent of those treated with conventional chemotherapy drugs.
Importantly, the duration of response was also much longer. Patients
on chemotherapy typically responded for 3.6 months, whereas 95
percent of those who responded to Opdivo were still benefiting after
six months and the median duration of response was not reached.
Patients in the study had previously been treated with the company's
Yervoy immunotherapy, which works in a different way to take natural
brakes off the immune system.
I was very nicely surprised," said Jeffrey Weber of the Moffitt
Cancer Center in Florida, who presented the results at the European
Society of Medical Oncology annual congress on Monday.
A 32 percent response rate with the majority staying in remission
past six months is probably going to turn into a very impressive
level of survival, he said. "I hope this is the death knell for
chemotherapy in melanoma."
Opdivo, or nivolumab, is part of a promising new class of drugs
designed to block a protein known as Programmed Death receptor
(PD-1), or a related target known as PD-L1, used by tumors to evade
the immune system's disease-fighting cells.
Industry analysts are waiting next to see how Opdivo performs in
another Phase III trial in lung cancer, for which they expect
results in the fourth quarter of 2014. Since non-small lung cancer
is a much bigger market than melanoma, that trial is viewed as
critical to the drug's commercial outlook.
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Some investors are nervous about Opdivo's lung cancer prospects but
Weber, for one, is upbeat. It is highly likely that the lung data
will be positive, he told Reuters.
Opdivo became the first PD-1 inhibitor to receive regulatory
approval anywhere in the world in July when Japanese regulators gave
it a green light, although it has been beaten to market in the
United States by Merck & Co's rival Keytruda, which was approved
earlier this month.
On Friday, Bristol-Myers said the U.S. Food and Drug Administration
had granted Opdivo a priority review and a decision on approval was
due by the end of March.
Companies such as Roche and AstraZeneca are also developing PD-1
pathway drugs for a variety of cancers, including lung cancer. Some
analysts expect the new class could generate more than $30 billion
in annual sales worldwide by 2025.
(Editing by Michael Urquhart, editing by Louise Heavens)
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