Exelixis (EXEL) on Monday announced positive top-line results from a phase 3 trial of the MEK inhibitor cobimetinib in combination with Zelboraf (vemurafenib) in untreated patients with melanoma harboring a specific mutation. The study, known as coBRIM, met its primary endpoint, producing a statistically significant benefit in progression-free survival (PFS) when combined with Zelboraf versus Zelboraf alone.
coBRIM is a 495-patient double-blind, placebo-controlled phase 3 study evaluating the safety and efficacy (primary endpoint of PFS) of the combination in patients with BRAFV600-positive melanoma. Overall survival is a secondary endpoint in the study.
This is the first of three major data events that Exelixis anticipates before the end of the year:
- Results from the phase 3 COMET-1 and COMET-2 (pain palliation endpoint) studies of cabozantinib in metastatic castration-resistant prostate cancer. Recall that COMET-1 was not stopped early for efficacy after an interim analysis in March, which disappointed investors and sent the stock down 30%.
- Overall survival results from EXAM, a phase 3 trial of cabozantinib in metastatic medullary thyroid cancer.
Exelixis also expects to complete enrollment in METEOR, a phase 3 trial of cabozantinib in metastatic renal cell cancer, by the end of the year.
Exelixis sold 10,000,000 shares of common stock at $8.00 early this year, bringing the company’s cash balance at the end of the first quarter to $408 million. operating expenses in the first quarter totaled about $70 million.
