Bristol-Myers Squibb Company BMY today announced positive results from
a Phase II trial (CheckMate -069), evaluating the Opdivo (nivolumab)+Yervoy
(ipilimumab) regimen versus Yervoy alone in patients with previously untreated
advanced melanoma. Patients with BRAF wild-type mutation status treated with
the Opdivo+Yervoy regimen experienced a higher objective response rate (ORR)
of 61% (n=44/72) – the primary study endpoint – compared to 11% (n=4/37) for
patients administered Yervoy monotherapy (P<0.001). Complete responses were
also reported in 22% (n=16) of patients with BRAF wild-type mutation status
administered the Opdivo+Yervoy regimen and in no patients who received Yervoy
monotherapy. Similar results were also observed in BRAF mutation-positive
patients. The safety profile was consistent with previously-reported studies
evaluating the Opdivo+Yervoy regimen and included grade 3-4 colitis
(17%), diarrhea (11%), and increased alanine aminotransferase (11%).
These data will be presented today at the American Association for Cancer
Research (AACR) Annual Meeting and featured during a press briefing at 8:30 AM
EDT [Abstract #2860]. The results will also be published in The New England
Journal of Medicine (NEJM).
"These data are unprecedented in advanced melanoma, showing efficacy results
that have not previously been observed with Immuno-Oncology agents," said F.
Stephen Hodi, M.D., Associate Professor of Medicine, Dana-Farber Cancer
Institute and an author of the NEJM manuscript. "With the Opdivo+Yervoy
regimen, we observed much higher response rates which were sustained, as well
as significant reduction in tumor burden than with Yervoy. These responses
seen in CheckMate -069 demonstrate the potential of this regimen in patients
with metastatic melanoma."
Melanoma is the most serious form of skin cancer and strikes adults of all
ages. While melanoma represents less than 5% of skin cancers, it results in
most deaths. The CheckMate -069 trial is the first randomized study reporting
outcomes in the first-line setting for advanced melanoma patients treated with
a regimen of immune checkpoint inhibitors compared to Yervoy. The efficacy and
safety results of CheckMate -069 are consistent with the Phase Ib dose-ranging
trial (CheckMate -004), which evaluated the safety and activity of the regimen
in patients with advanced melanoma.
"The CheckMate -069 results reinforce our belief that the future lies in the
combination of Immuno-Oncology agents, including Opdivo and Yervoy, that can
leverage the immune system in order to offer cancer patients options with
greater efficacy beyond current treatment approaches," said Michael Giordano,
senior vice president, Head of Development, Oncology. "Our strategy has always
been to build upon the success achieved with Yervoy. In 2011, long-term
survival for metastatic melanoma patients was unheard of, but the introduction
of Yervoy has helped to make this a reality for some patients. Now we are
building on this success with Opdivo, which was the first PD-1 inhibitor to
demonstrate an improved survival benefit."
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