| April 3
April 3 Patients with advanced melanoma who
received Bristol-Myers Squibb's immunotherapies Opdivo
and Yervoy had improved overall survival compared with those on
Yervoy alone, with 64 percent on the combination therapy still
alive after two years, according to data released on Monday.
The combination therapy won approval to treat the deadliest
form of skin cancer based on its ability to delay disease
worsening, known as progression-free survival, with the
condition that it ultimately helps patients live longer.
Data presented at the American Association for Cancer
Research meeting in Washington for the first time demonstrated
that overall survival benefit.
Prior to the introduction of these new drugs that help the
immune system fight cancer, including Keytruda from Merck & Co
, advanced melanoma was a short-term death sentence.
The new drugs do come at a hefty price. The combination
regimen used in the study costs about $145,200, Bristol said.
In the 945-patient late stage trial, median overall survival
for Yervoy, known chemically as ipilimumab, was 20 months.
Median overall survival had not yet been reached for the
combination or for Opdivo (nivolumab) alone, with a minimum
follow-up of 28 months.
After two years, 59 percent of those who got Opdivo alone
were still alive, while 64 percent of patients in the
combination group were alive.
"This level of survival rate at two years is really
unprecedented," said Fouad Namouni, Bristol's head of medical
and oncology development.
Put another way, the combination therapy reduced the risk of
death 45 percent compared with Yervoy, the company said.
No new safety issues turned up in the study, Bristol-Myers
said. However, the rate of serious adverse side effects was 58
percent for the combination, 21 percent for Opdivo and 28
percent for Yervoy.
"It is exciting to see that initial results suggest that the
nivolumab plus ipilimumab combination provides favorable
survival outcomes compared with ipilimumab alone," Dr. James
Larkin, the study's lead investigator, said in a statement.
The higher rate of severe side effects should be considered
when making treatment decisions, he added.
Bristol-Myers is looking to regain its standing in the
burgeoning immuno-oncology field. It ceded its perceived lead to
Merck last year, when Opdivo proved no better than chemotherapy
as an initial treatment for advanced lung cancer, by far the
biggest oncology market. Merck's Keytruda won approval as a
first-line treatment for advanced non-small cell lung cancer.
(Reporting by Bill Berkrot; Editing by Cynthia Osterman)