Merck, a global healthcare leader, known as MSD outside the United
States and Canada, announced results from the randomized, pivotal phase 3
study, Keynote-006, in the treatment of unresectable advanced melanoma.
In the study, Keytruda (pembrolizumab) was statistically superior to
ipilimumab for progression-free survival (PFS), overall survival (OS),
and overall response rate (ORR).
On March 24, 2015, Merck announced that Keynote-00 would be stopped early based on these data (link). The results were presented at the American Association for Cancer Research (AACR) annual meeting by Dr. Antoni Ribas of Jonsson Comprehensive Cancer Center, University of California, Los Angeles (abstract # CT101), included in the AACR press program, and were also published in the New England Journal of Medicine.
“Improving survival is the ultimate objective in treating patients with cancer. In this important study in advanced melanoma, Keytruda was statistically superior to ipilimumab for progression-free survival and overall survival, and also demonstrated a lower frequency of severe adverse events,” said Dr. Caroline Robert, head of dermatology at Gustave Roussy, Villejuif and Paris-Sud University Cancer Campus, Grand Paris and lead author of the New England Journal of Medicine publication.
In mid-2015, Merck plans to submit a supplemental Biologics License Application (sBLA) for Keytruda based on Keynote-006 for the first-line treatment of advanced melanoma. Merck recently submitted data from Keynote-002 in ipilimumab-refractory advanced melanoma as part of a supplemental application.
Keytruda was the first anti-PD-1 therapy approved in the United States and is currently indicated in the United States for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
On March 24, 2015, Merck announced that Keynote-00 would be stopped early based on these data (link). The results were presented at the American Association for Cancer Research (AACR) annual meeting by Dr. Antoni Ribas of Jonsson Comprehensive Cancer Center, University of California, Los Angeles (abstract # CT101), included in the AACR press program, and were also published in the New England Journal of Medicine.
“Improving survival is the ultimate objective in treating patients with cancer. In this important study in advanced melanoma, Keytruda was statistically superior to ipilimumab for progression-free survival and overall survival, and also demonstrated a lower frequency of severe adverse events,” said Dr. Caroline Robert, head of dermatology at Gustave Roussy, Villejuif and Paris-Sud University Cancer Campus, Grand Paris and lead author of the New England Journal of Medicine publication.
In mid-2015, Merck plans to submit a supplemental Biologics License Application (sBLA) for Keytruda based on Keynote-006 for the first-line treatment of advanced melanoma. Merck recently submitted data from Keynote-002 in ipilimumab-refractory advanced melanoma as part of a supplemental application.
Keytruda was the first anti-PD-1 therapy approved in the United States and is currently indicated in the United States for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
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