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Exelixis Collaborator Genentech Submits New Drug Application for Cobimetinib and Vemurafenib Combination

Strategic Insights

— 1 min read

Exelixis' collaborator Genentech has completed the filing of its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. This marks a significant step forward in the development of cobimetinib, which has received Fast Track designation by the FDA. The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.

Key Takeaways:

  • Genentech, a member of the Roche Group, has completed the filing of its NDA with the FDA for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation.
  • Cobimetinib has received Fast Track designation by the FDA, which expedites the review process for drugs that demonstrate the potential to address unmet medical needs.
  • The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.
  • coBRIM met its primary endpoint, demonstrating a statistically significant increase in investigator-determined progression-free survival (PFS) compared to vemurafenib alone.
  • The median PFS was 9.9 months for the combination of cobimetinib and vemurafenib versus 6.2 months for vemurafenib alone, with a hazard ratio of 0.51 (95% CI 0.39-0.68) and a p-value of < 0.001.

Statistics:

  • 495 patients participated in the coBRIM trial, a phase 3 pivotal trial conducted by Genentech.
  • The median PFS was 9.9 months for the combination of cobimetinib and vemurafenib versus 6.2 months for vemurafenib alone.
  • Hazard ratio (HR) for PFS was 0.51 (95% CI 0.39-0.68).
  • P-value for the primary endpoint of PFS was < 0.001.

Sources:

  • Exelixis, Inc. (NASDAQ:EXEL)
  • Genentech, a member of the Roche Group
  • U.S. Food and Drug Administration (FDA)
  • European Society for Medical Oncology 2014 Congress
  • NewsRx LLC (2014)

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