Combined Vemurafenib and Cobimetinib in BRAF -Mutated Melanoma
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Discussion
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Implication
Randomized trial demonstrates improved progression-free survival with dual BRAF and MEK inhibition in advanced melanoma, highlighting the efficacy of combination targeted therapy.
Key Points
- To determine whether combining the MEK inhibitor cobimetinib with the BRAF inhibitor vemurafenib delays resistance and improves progression-free survival compared with vemurafenib alone in advanced BRAF V600-mutated melanoma.
- Randomized, double-blind, placebo-controlled phase 3 trial (coBRIM, NCT01689519) involving 495 patients with previously untreated, unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma.
- Participants were randomly assigned to receive either vemurafenib combined with cobimetinib or vemurafenib combined with placebo, with investigator-assessed progression-free survival as the primary endpoint.
- Median progression-free survival was 9.9 months in the combination group versus 6.2 months in the control group (HR for death or disease progression, 0.51; 95% CI, 0.39 to 0.68; P<0.001).
- The confirmed objective response rate was 68% (10% complete response) with combination therapy versus 45% (4% complete response) with vemurafenib and placebo (P<0.001).
- Grade 3 or higher adverse events occurred in 65% of patients in the combination group compared with 59% in the control group, while secondary cutaneous cancers decreased with combination therapy.
Cite This Study
Larkin et al. (2014) studied this question.