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European Union

Exelixis' COTELLIC Receives Third Regulatory Approval for Melanoma Treatment

Strategic Insights

— 2 min read

Exelixis has announced that the European Commission has approved COTELLIC, a combination therapy for unresectable or metastatic melanoma with a BRAF V600 mutation. This approval joins Switzerland (August 2015) and the United States (November 2015) as the third regulatory approval for COTELLIC. The therapy, discovered by Exelixis and developed by Exelixis and Genentech, a member of the Roche Group, is a combination of cobimetinib and vemurafenib. The European approval is based on the results of the phase 3 coBRIM study, which demonstrated a significant improvement in progression-free survival (PFS) for patients receiving the combination therapy compared to vemurafenib alone.

Key Takeaways:

  • COTELLIC, a combination therapy of cobimetinib and vemurafenib, has received its third regulatory approval for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation, joining Switzerland (August 2015) and the United States (November 2015).
  • The European approval is based on the results of the phase 3 coBRIM study, which demonstrated a significant improvement in progression-free survival (PFS) for patients receiving the combination therapy compared to vemurafenib alone.
  • The coBRIM study enrolled 495 patients with previously untreated BRAF V600 mutation-positive advanced melanoma and demonstrated a median PFS of 12.3 months for patients receiving the combination therapy compared to 7.2 months for those receiving vemurafenib alone.
  • The combination therapy was well-tolerated, with the most common side effects including diarrhea, sunburn or sun sensitivity, nausea, fever, and vomiting.
  • Exelixis is eligible to receive royalties on ex-U.S. sales of COTELLIC under the collaboration agreement with Genentech, a member of the Roche Group.
  • Exelixis and Genentech have a worldwide collaboration agreement for the development and commercialization of COTELLIC, under which Exelixis has received upfront and milestone payments and is eligible to receive royalties on sales outside the United States.
  • Exelixis will share in U.S. profits and losses and U.S. sales and marketing costs for COTELLIC in the United States under a co-promotion agreement with Genentech.

Statistics:

  • Median progression-free survival (PFS) was 12.3 months for patients receiving cobimetinib plus vemurafenib in the phase 3 coBRIM study.
  • The objective response rate (ORR) for patients receiving the combination therapy was 70%, compared to 50% for those receiving vemurafenib alone.
  • The hazard ratio (HR) for PFS was 0.58 (95% CI: 0.46-0.72) for patients receiving the combination therapy compared to vemurafenib alone.
  • The most common side effects of COTELLIC included diarrhea, sunburn or sun sensitivity, nausea, fever, and vomiting.

Sources:

  • Businesswire: http://www.businesswire.com/news/home/20151125005441/en/
  • American Cancer Society:
  • Exelixis press release:
  • Exelixis quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 11, 2015.

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