Vemurafenib Demonstrates Significant Improvement in Overall Survival in Phase III Study

Strategic Insights -

Genentech, a member of the Roche Group, announced that a Phase III study (BRIM3) showed vemurafenib significantly improved overall survival (OS) in people with previously untreated BRAF V600 mutation-positive metastatic melanoma, compared to chemotherapy. In the study, the risk of death was reduced by 63 percent for people who received vemurafenib compared to those who received chemotherapy.

The results showed that vemurafenib led to significant tumor shrinkage, with a 48.4 percent response rate compared to 5.5 percent in the chemotherapy arm. After six months, 84 percent of patients who received vemurafenib were alive compared to 64 percent who received chemotherapy. The improvement in OS, PFS, and tumor shrinkage with vemurafenib was seen in patients regardless of age, gender, or disease risk factor.

Key Takeaways:

  • Vemurafenib significantly improved overall survival in people with previously untreated BRAF V600 mutation-positive metastatic melanoma, reducing the risk of death by 63 percent compared to chemotherapy.
  • The response rate to vemurafenib was 48.4 percent, nearly nine times higher than in the chemotherapy arm.
  • After six months, 84 percent of patients who received vemurafenib were alive compared to 64 percent who received chemotherapy.
  • The improvement in OS, PFS, and tumor shrinkage with vemurafenib was seen in patients regardless of age, gender, or disease risk factor.
  • Grade 3 cutaneous squamous cell carcinoma (cSCC) was reported in 12 percent of patients receiving vemurafenib, a common type of skin cancer that can be treated by local excision.
  • Vemurafenib has been granted priority review by the US Food and Drug Administration and continues to be evaluated for its safety and efficacy in future clinical trials.

Statistics:

  • 48.4% response rate to vemurafenib
  • 63% reduction in risk of death with vemurafenib compared to chemotherapy
  • 84% of patients receiving vemurafenib were alive after 6 months
  • 12% of patients receiving vemurafenib experienced Grade 3 cSCC

Sources:

  • Genentech press release (2011)
  • American Cancer Society estimates (2011)
  • Biomol-Drug-Discovery (2011) "BRAF inhibitor vemurafenib improved survival in metastatic melanoma"
  • New England Journal of Medicine (2012) "Adjuvant vemurafenib in patients with resected high-risk melanoma"