Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the quarter ended September 30, 2013.
Q3 2013 Highlights and Recent Events
- Reported net product revenue for COMETRIQ® (cabozantinib) of $4.8 million in the third quarter of 2013.
- Reached the enrollment target of 960 patients for COMET-1, the phase 3 pivotal trial of cabozantinib in patients with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint of COMET-1 is overall survival (OS). Top-line data from COMET-1 and a second pivotal trial in mCRPC, COMET-2, with the primary endpoint of pain response in patients with bone pain associated with bone metastases, are expected in 2014.
- Initiated CELESTIAL, a phase 3 pivotal trial comparing cabozantinib to placebo in patients with advanced hepatocellular carcinoma (HCC) who have previously been treated with sorafenib. The trial is expected to enroll 760 patients at up to 200 sites globally in up to 30 countries. The primary endpoint is OS, and the secondary endpoints include objective response rate (ORR) and progression-free survival (PFS).
- Announced updated results from BRIM7, an ongoing phase 1b clinical trial conducted by Roche and Genentech, Exelixis' collaborator and a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) at the European Cancer Congress 2013. The study is evaluating the BRAF inhibitor (BRAFi) vemurafenib in combination with the MEK inhibitor cobimetinib (GDC-0973/XL518) in patients with locally advanced/unresectable or metastatic melanoma carrying a BRAF V600 mutation. The ORR (comprising complete or partial responses) was 85% in the cohort of BRAFi-naïve patients. As previously announced, Genentech is conducting a phase 3 pivotal trial evaluating vemurafenib alone or in combination with cobimetinib in previously untreated patients with malignant melanoma and the BRAF V600 mutation, for which data are expected in 2014.
"The continued progress of our clinical development program is illustrated by the five ongoing pivotal trials investigating cabozantinib in multiple indications, including the METEOR trial in metastatic renal cell cancer (RCC) and the CELESTIAL trial in advanced HCC," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "Top-line data from COMET-1 and COMET-2 and the overall survival analysis for EXAM are expected in 2014. Additionally, the phase 3 pivotal trial of vemurafenib alone or in combination with cobimetinib is also expected to report data in 2014. Thus, we believe 2014 will be an important year for Exelixis with the potential read out of a total of four phase 3 pivotal trials for the Exelixis-discovered compounds cabozantinib and cobimetinib."