Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the quarter ended June 30, 2013.
Q2 2013 Highlights and Recent Events
- Reported net product revenue for COMETRIQ® (cabozantinib) of $4.0 million in the second quarter of 2013.
- Expanded the sales force to 14 representatives.
- Initiated METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with at least one prior VEGFR tyrosine kinase inhibitor (TKI). The trial is expected to enroll 650 patients, and the primary endpoint is progression-free survival (PFS). The secondary endpoint is overall survival (OS) and no cross-over will be allowed between the study arms.
- Cabozantinib was the subject of nine presentations at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in June, including an oral presentation of data from the EXAM study, Exelixis' phase 3 pivotal trial in progressive, metastatic medullary thyroid cancer (MTC), as well as a poster discussion presentation of overall survival data from patients with metastatic castration-resistant prostate cancer (CRPC) in a non-randomized expansion (NRE) cohort of Exelixis' phase 2 randomized discontinuation trial. Additional presentations covered cabozantinib's potential activity in investigational studies of advanced urothelial carcinoma, metastatic uveal melanoma, and CRPC metastatic to the bone.
“We gained significant momentum in both commercial and development activities in the second quarter of 2013,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “While continuing to focus on enrollment of the COMET phase 3 pivotal trials as our top priority, we initiated the METEOR phase 3 pivotal trial in metastatic RCC and finalized planning for our phase 3 pivotal trial in metastatic hepatocellular carcinoma (HCC). In addition, the overall survival and post-hoc analyses from the phase 2 NRE metastatic CRPC cohort were presented at the ASCO Annual Meeting and those data continue to support the rationale for the COMET pivotal trials in metastatic CRPC, for which we continue to expect top-line data in 2014."