Exelixis, Inc. (Nasdaq:EXEL) today reported financial results for the quarter ended June 30, 2014.
Q2 2014 Highlights and Recent Events
- Reported positive top-line results from coBRIM, the phase 3 pivotal trial evaluating cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. On July 11, 2014, Exelixis’ collaborator Genentech, a member of the Roche Group, informed the company that coBRIM met its primary endpoint, delivering a statistically significant increase in progression-free survival for the combination of cobimetinib plus vemurafenib versus vemurafenib alone. Adverse events were consistent with those observed in a previous study of the combination. Roche announced last week on their second quarter 2014 earnings conference call that the coBRIM data are planned for presentation at the European Society for Medical Oncology 2014 Congress taking place in Madrid, Spain, September 26 - 30, 2014. They have also stated that they plan to initiate regulatory filings before year end.
- Cabozantinib and cobimetinib were the subject of a total of ten presentations at the 2014 Annual Meeting of the American Society of Clinical Oncology, which was held May 30 to June 3, 2014 in Chicago, Illinois. Cabozantinib presentations included data from trials sponsored by Exelixis, independent investigators, and the National Cancer Institute’s Cancer Therapy Evaluation Program. Cobimetinib was the subject of one oral presentation highlighting positive data from BRIM7, the phase 1b clinical trial conducted by Roche and Genentech which evaluated the combination of cobimetinib and vemurafenib in patients with locally advanced/unresectable or metastatic melanoma carrying a BRAF V600 mutation.
- Announced final positive results from BRIM7 at the European Association of Dermato-Oncology Congress, which was held May 7-10, 2014 in Vilnius, Lithuania.
- Net product revenue from COMETRIQ® (cabozantinib) sales was $6.6 million for the second quarter of 2014.
“The Exelixis team made substantial clinical and commercial progress during the second quarter of 2014, driving the company forward for an impactful year,” said Michael M. Morrissey, Ph.D., president and chief executive officer of the company. “The positive top-line results from the coBRIM pivotal trial, which we and our partner Genentech reported shortly after the quarter ended, are an important advance for the melanoma community, and they serve as further validation of Exelixis’ ability to discover and develop therapies with the potential to improve the treatment of cancer patients.”