Merck announced results from the Phase 3 KEYNOTE-006 study investigating Keytruda (pembrolizumab) vs. ipilimumab in the first-line treatment of patients with advanced melanoma. Since the primary endpoints have been met, the trial will be stopped early based on the recommendation of the study’s Independent Data Monitoring Committee.
KEYNOTE-006 is a global, open-label, randomized, pivotal study which evaluated Keytruda compared to ipilimumab in patients with unresectable stage III or IV advanced melanoma with no more than one prior systemic therapy. The study randomized 834 patients to receive Keytruda 10mg/kg every three weeks, Keytruda 10mg/kg every two weeks, or four cycles of ipilimumab 3mg/kg every three weeks. The co-primary endpoints were progression-free survival (PFS) and overall survival (OS). Tumor response was assessed at week 12, then every 6 weeks thereafter. Keytruda demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival compared to ipilimumab.
Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, Keytruda releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Keytruda is already indicated 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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