EXEL writeup,

News this morning:

Exelixis Announces Independent Radiology Committee Review Confirms Results from CABOSUN, the Phase 2 Trial of Cabozantinib versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma
Business WireJune 19, 2017

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--

Exelixis, Inc. (EXEL) announced today that the analysis of the review by a blinded independent radiology review committee (IRC) has confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS) from the CABOSUN randomized phase 2 trial of cabozantinib as compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS. Exelixis remains on target to complete a supplemental New Drug Application (sNDA) for cabozantinib as a treatment of first-line advanced renal cell carcinoma in the third quarter of 2017.

CABOSUN was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ agreement with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP). Exelixis and the Alliance cooperative group plan to submit these results for presentation at an upcoming international medical meeting.

“We are very pleased that CABOSUN’s primary endpoint of a statistically significant improvement of progression-free survival has been confirmed by the independent radiology review committee,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We continue in our focused efforts to complete the regulatory filing of cabozantinib for the treatment of patients with previously untreated advanced renal cell carcinoma and are on track to submit a supplemental New Drug Application in the third quarter of this year. Patients in the first-line setting with either intermediate- or poor-risk disease progress rapidly with sunitinib, a current standard of care, highlighting a clear need for new options that provide improved clinical benefit in this difficult to treat patient population.”

About the CABOSUN Study

On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS compared with sunitinib in patients with advanced intermediate- or poor-risk RCC as determined by investigator assessment. CABOSUN was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the NCI-CTEP. These results were first presented by Dr. Toni Choueiri at the meeting of the European Society for Medical Oncology (ESMO) 2016, and published in the Journal of Clinical Oncology (Choueiri, JCO, 2016).1

CABOSUN was a randomized, open-label, active-controlled phase 2 trial that enrolled 157 patients with advanced RCC determined to be intermediate- or poor-risk by the IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, four weeks on followed by two weeks off). The primary endpoint was PFS. Secondary endpoints included overall survival and objective response rate. Eligible patients were required to have locally advanced or metastatic clear-cell RCC, ECOG performance status 0-2, and had to be intermediate or poor risk per the IMDC criteria (Heng, JCO, 2009).2 Prior systemic treatment for RCC was not permitted.

Please see Important Safety Information below and full U.S. prescribing information at cabometyx.com/downloads/cabometyxuspi.pdf.

About Advanced Renal Cell Carcinoma

The American Cancer Society’s 2017 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.3 Clear cell RCC is the most common type of kidney cancer in adults.4 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12 percent, with no identified cure for the disease.5 Approximately 30,000 patients in the U.S. and 68,000 globally require treatment.6

The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.7,8 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.9-12 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.8,9
===============================

C L