Exelixis: The European Commission approves Cabometix for first line treatment of poor-risk advanced renal cell carcinoma

Exelixis (EXEL) announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX®(cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate or poor-risk advanced renal cell carcinoma (RCC) in the European Union.

Under the terms of the Collaboration and License Agreement with Ipsen, Exelixis will receive a milestone payment of $50 million for the EC approval, of which approximately $46 million was recognized as collaboration revenue in the first quarter of 2018. The payment will be made by Ipsen within the next 70 days.

Cabometix was approved in the European Union in September 2016 for advanced RCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. It was FDA approved in the United States in December 2017 for the expanded indication of patients with advanced RCC also based on the results from the CABOSUN trial.  These results showed that the trial met its primary endpoint, demonstrated 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.

The CABOSUN study was conducted by The Alliance for Clinical Trials in Oncology and was sponsored by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) under the Cooperative Research and Development Agreement with Exelixis for the development of cabozantinib.

Prohost Observations

Cabometix becoming a first-line treatment for RCC is good news for Exelixis. It means additional revenues for the firm. The American Cancer Society most recent statistics consider kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S. Clear cell RCC is the most common type of kidney cancer in adults. 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. Approximately 30,000 patients in the U.S. and 68,000 globally require treatment, and an estimated 14,000 patients in the U.S. each year are in need of a first-line treatment for advanced kidney cancer.

The upgrade in Europe was made based on solid results from a trial that met its primary endpoint of improved progression-free survival (PFS) compared with sunitinib in patients with previously untreated advanced RCC, which was determined to be intermediate- or poor-risk by the International Metastatic RCC Database Consortium (IMDC) criteria.

The success of cabometix in RCC is explicable and should not be surprising. The drug inhibits the activity of tyrosine kinases, including MET, AXL, VEGF receptors. 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. These proteins are known to promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.  MET and AXL may also provide escape pathways that drive resistance to VEGF receptor inhibitors.

The News is indeed good for Exelixis and especially for the patients who are considered poor-risk.

Click the following link to see Important Safety Information and the full U.S. prescribing information of Cabometix: https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

In premarket hours, EXEL is trading at $21.10 UP $0.69

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