Actionable news
0
All posts from Actionable news
Actionable news in EXEL: Exelixis, Inc.,

Exelixis Announces Presentation of Positive Overall Survival Results for COTELLIC

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (NASDAQ:EXEL) today announced the presentation of positive overall survival (OS) results from coBRIM, the phase 3 pivotal trial evaluating COTELLIC (cobimetinib) in patients with previously untreated resectable, locally advanced or metastatic melanoma carrying a BRAF V600E or V600K mutation, in combination with vemurafenib. Dr. Victoria Atkinson, Medical Oncologist at Princess Alexandra Hospital, Queensland, Australia, presented the data during a late-breaking abstract oral presentation this afternoon at the Society for Melanoma Research (SMR) 2015 International Congress, which is being held November 18-21 in San Francisco. COTELLIC is a selective inhibitor of MEK that was discovered by Exelixis and is now the subject of a worldwide collaboration agreement between Exelixis and Genentech, a member of the Roche Group.

“The overall survival benefit for COTELLIC and vemurafenib observed in the coBRIM trial further underscores the positive impact that the combination of these two therapies can have on the treatment of advanced BRAF V600 mutation-positive melanoma”

Tweet this

In October 2015, Exelixis announced the coBRIM trial met its OS secondary endpoint, demonstrating a statistically significant increase in OS for the combination of COTELLIC and vemurafenib compared to vemurafenib monotherapy. Today’s presentation was the first to include detailed data on the endpoint. The median OS was 22.3 months for the combination of COTELLIC and vemurafenib versus 17.4 months for vemurafenib alone, corresponding to a 30% reduction in the rate of death for the combination as compared to vemurafenib alone (hazard ratio [HR]=0.70, 95% confidence interval [CI] 0.55-0.90, p= 0.005). Ongoing study monitoring did not identify any new safety signals.

“The overall survival benefit for COTELLIC and vemurafenib observed in the coBRIM trial further underscores the positive impact that the combination of these two therapies can have on the treatment of advanced BRAF V600 mutation-positive melanoma,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis.

On November 10, 2015, the U.S. Food and Drug Administration (FDA) approved COTELLIC as a treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, in combination with vemurafenib. COTELLIC was first approved in Switzerland in late August 2015. The COTELLIC approvals are based on data from coBRIM, the phase 3 pivotal trial conducted by Genentech in 495 patients with previously untreated unresectable, locally advanced or metastatic melanoma carrying a BRAF V600 mutation (detected by the cobas® 4800 BRAF Mutation Test). Genentech sponsored the U.S. New Drug Application and Roche sponsored the Swiss regulatory application. Roche also filed a Marketing Authorization Application (MAA) with the European Medicines Agency in late 2014, and the Committee for Medicinal Products for Human Use issued a positive recommendation on the MAA in September 2015. Roche anticipates a decision from the European Commission by year-end.

About the COTELLIC Development Collaboration

Exelixis discovered COTELLIC internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a worldwide collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND. Following the determination of the maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its option to further develop COTELLIC.

Under the terms of collaboration, Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share in U.S. marketing and commercialization costs. In November 2013, Exelixis exercised its option to co-promote COTELLIC in the United States and, under the terms of the agreement, the company is fielding 25 percent of the U.S. sales force, closely coordinating its efforts with Genentech. Outside of the United States, Exelixis is eligible to receive royalties on any sales.

About COTELLIC in Combination with Vemurafenib

COTELLIC and vemurafenib are prescription medicines used in combination to treat melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene. Found in approximately half of melanomas, mutated BRAF causes abnormal signaling inside cancer cells leading to tumor growth. Vemurafenib is designed to inhibit some mutated forms of BRAF and COTELLIC is designed to inhibit some forms of MEK. Both BRAF and MEK are proteins in a cell signaling pathway that help control cell growth and survival. When used in combination, COTELLIC and vemurafenib are thought to reduce cancer cell growth longer than with vemurafenib alone. A patient’s healthcare provider will perform a test to make sure COTELLIC and vemurafenib are right for the patient. It is not known if COTELLIC and vemurafenib are safe and effective in children under 18 years of age.

About the coBRIM Trial

CoBRIM is an international, randomized, double-blind, placebo-controlled phase 3 study evaluating the safety and efficacy of 60 mg once daily of cobimetinib plus 960 mg twice daily of vemurafenib compared to 960 mg twice daily of vemurafenib plus placebo. In the study, 495 patients with...


More