(Malignant Melanoma) Cobimetinib Plus Vemurafenib: coBRIM Phase 3 Trial Results

• August 5, 2016
• 1 min read

On August 3, 2016, The Lancet Oncology published results demonstrating that the combination of cobimetinib and vemurafenib is effective as first-line treatment for BRAF V600 mutation-positive malignant melanoma.

Vemurafenib is a BRAF inhibitor used in malignant melanoma treatment. The coBRIM trial evaluated vemurafenib combined with cobimetinib (brand name Cotellic, a MAPK MEK inhibitor), confirming a median PFS of 12.3 months. With vemurafenib alone, median PFS was 7.2 months (p<0.0001).

At data analysis (August 28, 2015), 52% of patients had died. Median OS: cobimetinib combination 22.3 months vs. vemurafenib alone 17.4 months (p<0.005).

coBRIM Trial Design (NCT01689519):

The coBRIM trial began in January 2013 across 193 sites in the United States, Europe, Russia, and Israel. It enrolled 495 patients with BRAF V600 mutation-positive unresectable Stage 3c or Stage 4 malignant melanoma. Patients were randomized 1:1 to cobimetinib or placebo, both administered with vemurafenib. Treatment cycle was 28 days: cobimetinib 60 mg once daily for Days 1–21, then 7 days off; vemurafenib 960 mg for all 28 days. Primary endpoints were PFS and OS duration.

Conclusion: The coBRIM trial demonstrated that combination cobimetinib plus vemurafenib is effective for patients with BRAF V600 mutation-positive malignant melanoma.

Source: A Phase III Study Comparing Vemurafenib vs Vemurafenib Plus Cobimetinib (GDC-0973) in Patients With Metastatic Melanoma (coBRIM)

Malignant Melanoma | BRAF V600 | MEK Inhibitor | Targeted Therapy

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