* Roche, Bristol-Myers drugs improve survival
* Melanoma experts call studies "unprecedented"
(Adds analyst comments, other details)
By Julie Steenhuysen and Deena Beasley
CHICAGO, June 5 Two new drugs using very
different scientific approaches can extend survival among
patients with the deadliest form of skin cancer, offering the
first new hope for real progress in many years.
Advanced melanoma patients taking an experimental pill,
vemurafenib, developed by Roche ROG.VX and Daiichi Sankyo
(4568.T) were 63 percent less likely to die than patients given
chemotherapy, according to a new trial presented on Sunday at a
meeting of the American Society of Clinical Oncology in
Dr. Paul Chapman of Memorial Sloan-Kettering Cancer Center
in New York and the study's lead investigator called the
results an "unprecedented level of difference" for patients
with advanced melanoma, who typically survive just eight months
on current treatments.
In a separate study presented at ASCO, previously untreated
people with advanced melanoma treated with Bristol-Myers
Squibb's (BMY.N) Yervoy, or ipilimumab, plus chemotherapy lived
an average of two months longer than people who got
Yervoy works by spurring the immune system to fight off the
cancer. Vemurafenib is designed for use in patients with tumors
that have a mutation in a gene known as BRAF that allows
melanoma cells to grow. About half of all melanomas have the
The Roche trial included 675 patients with previously
untreated, inoperable late-stage metastatic melanoma with the
After a median three months of treatment, vemurafenib
patients also had a 74 percent reduction in the risk of cancer
progression compared to dacarbazine.
"This is a huge difference," said Dr. Antoni Ribas, an
oncologist at the University of California, Los Angeles, who
has studied vemurafenib. "Even if it diminishes over time, who
"Nearly half of patients treated with the Roche drug had
tumor shrinkage, compared with 5.5 percent with chemotherapy.
Side effects included skin rashes and joint pain. About 18
percent of patients developed a low-grade skin cancer.
More than 70,000 people in the United States and 160,000
worldwide are diagnosed with melanoma each year, according to
the American Cancer Society. The five-year survival rate for
the aggressive cancer is just 15 percent.
Analysts, on average, have forecast annual vemurafenib
sales of $452 million by 2015 and expect Yervoy annual sales of
$1.26 billion, according to Thomson Pharma.
ISI Group analyst Mark Schoenebaum said although the
vemurafenib results look the most encouraging, the findings are
unlikely to make a difference for current sales estimates,
since virtually all eligible patients will be treated with both
drugs, either in sequence or in combination.
MORE HELP FOR MELANOMA PATIENTS
Roche expects U.S. and European regulators to decide on
approval of its drug before the end of the year.
Bristol-Myers' Yervoy was approved in March for patients
with inoperable or metastatic melanoma, based on a previous
study which showed the drug given alone extended survival by
four months in patients who had failed other treatments.
"What was interesting about this study was not only was it
the second one to show a benefit," but that the improvement
"took place even in the presence of dacarbazine chemotherapy,"
Dr. Jedd Wolchok of Memorial Sloan-Kettering Cancer Center in
New York, who presented the study at the meeting, said in a
"We worried a lot that chemotherapy could be
immunosuppressive," Wolchok said, noting that that might
explain why the average survival benefit was two months instead
"We don't know what dacarbazine did to the ipilimumab, but
we do know even in the presence of dacarbazine, ipilimumab
still produced a durable response and extended survival."
Doctors said taken together the new studies offer new
options for patients.
"This is really unprecedented time to have two new
approaches to treat advanced melanoma," said Dr. Lynn Schuchter
of the University of Pennsylvania in Philadelphia, a melanoma
expert who moderated a panel discussion of the drugs.
"Once you finally understand what is driving the disease we
can develop therapies that are more effective," she said.
She and others expect vemurafenib to be approved this year.
Meanwhile, doctors are already working out treatment
For patients who are stable with slow-growing tumors,
Chapman said he would start them off on ipilimumab.
"That is a drug that can take a while to work, so if the
person has time I would rather give him essentially two shots
on goal rather than one."
For advanced patients who need a quick response, he would
use vemurafenib first.
Schuchter, who was not involved with the studies, said now
the future is going to be to build upon this success and
"Cancer cells outwit us -- they are brilliant -- and figure
out other pathways," she said.
Bristol-Myers and Roche announced earlier this week a
collaboration to evaluate the combination of Yervoy and
vemurafenib as a therapy for metastatic melanoma.
(Editing by Bill Trott and Marguerita Choy)