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news.Merck has reported positive results from a pivotal Phase II trial (KEYNOTE-002) of its anti-PD-1 therapy pembrolizumab in patients with ipilimumab-refractory advanced melanoma.
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Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2.
The trial evaluated pembrolizumab at doses of 2mg/kg every three weeks and 10mg/kg every three weeks compared to investigator’s choice chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine or temozolomide) in these patients.
Merck Research Laboratories vice-president of global clinical development for oncology Dr Eric Rubin said: "These findings demonstrate pembrolizumab was superior to chemotherapy in helping more patients with ipilimumab-refractory advanced melanoma achieve progression-free survival.
"The comparative efficacy and safety data from the pivotal KEYNOTE-002 study validate and extend the findings from our earlier study in these difficult-to-treat patients, and we look forward to sharing data on overall survival at a future congress."
The global, randomized Phase II KEYNOTE-002 trial showed that pembrolizumab improved the primary endpoint of progression-free survival (PFS), compared to chemotherapy.
The trial’s co-primary endpoints were PFS and overall survival, while secondary endpoints included overall response rate (ORR), duration of response and safety; and health-related quality of life (HRQoL) as a pre-specified exploratory endpoint.
The trial was designed with co-primary endpoints of PFS and overall survival and an evaluation of overall survival is planned at the pre-specified final analysis in 2015.