Phase 3 trial of regimen for advanced melanoma misses primary endpoint
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A randomized phase 3 trial designed to evaluate the addition of spartalizumab to two targeted agents for the treatment of certain patients with advanced melanoma failed to meet its primary endpoint, according to the agent’s manufacturer.
The double-blind, placebo-controlled COMBI-i trial included patients with previously untreated, unresectable or metastatic BRAF V600 mutation-positive melanoma.
Researchers randomly assigned patients to the BRAF inhibitor dabrafenib (Tafinlar, Novartis) and the MEK1/2 inhibitor trametinib (Mekinist, Novartis) plus placebo or the investigational immunotherapy spartalizumab (PDR001, Novartis). Spartalizumab is an investigational monoclonal antibody directed against PD-1.
Results showed no statistically significant difference in investigator-assessed PFS — the study’s primary endpoint — between treatment groups.
“[Although] the COMBI-i trial did not reach its primary endpoint, the study’s findings give us valuable insights into the role the investigational immunotherapy spartalizumab may play in future cancer therapy combinations and underscore the previously established importance of Tafinlar plus Mekinist for these patients,” John Tsai, MD, head of global drug development and chief medical officer for Novartis, said in a company-issued press release.
Complete results from COMBI-i will be submitted for presentation at a future medical meeting.
The dabrafenib-trametinib combination is approved in the United States for treatment of certain patients with melanoma, non-small cell lung cancer and anaplastic thyroid cancer.
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