Exelixis: Important Collaborative Agreements with Roche and Bristol-Myers Squibb

Exelixis (EXEL) announced a new collaboration with Roche on a phase 1b dose escalation study of a combination of Exelixis cabozantinib in combination with Roche’s anti-PD-L1 immuno-therapy drug atezolizumab. The study aims at evaluating the safety and tolerability  of the combination in patients with locally advanced or metastatic solid tumors. Enrollment is scheduled to begin mid-year 2017. Exelixis will sponsor the trial, and Roche will provide atezolizumab.

Ipsen, Exelixis’ partner for cabozantinib outside the United States and Japan, will participate in this study and will have access to the results for potential future development in its territories. Takeda may also participate in these and future studies and will have access to the results in order to support potential future regulatory submissions in this firm’s territories.

The co-director, Kidney Cancer Program at City of Hope, and principal investigator in the study, Sumanta Kumar Pal, M.D., said, “People with advanced genitorurinary malignancies are in need of additional treatment options that can improve clinical outcomes. Dr. Kumar Pal added, “The combined approach of tyrosine kinase inhibition with cabozantinib alongside immune-checkpoint inhibition has already shown promise in an early phase 1 clinical trial…”

In an ongoing phase 1 clinical trial in subjects with refractory metastatic UC and other genito-urinary tumors, cabozantinib has been evaluated in combination with nivolumab, Bristol-Myers Squibb’s monoclonal antibody targeting PD-1. The combination was well-tolerated among all enrolled subjects, no dose-limiting toxicities were reported, and the recommended phase 2 dose was determined.

Exelixis’ drug cabozantinib is a potent inhibitor of multiple receptor tyrosine kinases, including MET, VEGFR, AXL and RET. Some of these receptors have also been implicated in promoting an immunosuppressive tumor microenvironment. Cabozantinib has demonstrated broad preclinical and clinical activity across several tumor types.

Cabozantinib tablets (60 mg) are approved as Cabometyx™ in the United States and Europe for advanced renal cell carcinoma (RCC) patients who received prior anti-angiogenic/VEGF-targeted therapy.

Cabozantinib capsules (140 mg) are approved as Cometriq® for the treatment of progressive, metastatic medullary thyroid cancer (MTC) in the United States and Europe.

Genitourinary cancers are those that affect the urinary tract, bladder, kidneys, ureter, prostate, testicles, penis or adrenal glands — parts of the body involved in reproduction and excretion — and include renal cell carcinoma and urothelial carcinoma.

Kidney cancer is among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S., according to the American Cancer Society’s 2016 statistics.5 Clear cell RCC is the most common type of kidney cancer in adults.6 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.

Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively. Urothelial carcinoma occurs mainly in older people, with 90 percent of patients aged 55 or older.9 Bladder cancer is the fourth most common cancer in men and accounts for about five percent of all new cases of cancer in the U.S. each year.9 In 2013, an estimated 587,426 people were living with bladder cancer in the U.S.

Please go to the Press release at Exelixis Website: www.exelixis.com/ so you can read about the trial details, Cabometyx, and the important safety information.


This agreement is between Exelixis and Bristol-Myers Squibb. The firms entered into a clinical development collaboration to evaluate Exelixis drug Cabometyx™ with Bristol-Myers Squibb’s checkpoint inhibitor drug Obdivo either alone or in combination with Yervoy.

The program will be co-funded by the companies and is expected to include a phase 3 pivotal trial in first-line renal cell carcinoma, with additional trials planned in bladder cancer, hepatocellular carcinoma (HCC), and potentially other tumor types.

Published preclinical and clinical data provided a scientific rationale for combining Cabometyx with immunotherapies. This includes phase 1 data of Cabometyx in combination with Opdivo in patients with previously treated genitourinary tumors that were presented at the European Society for Medical Oncology (ESMO) 2016 Congress.

Prohost Observations

Exelixis is on the right track, investigating, without delay, the efficacy of its product Cabozantinib with the three approved immunotherapy products Keytruda, Obdivo and Yervoy. The immu-nooncology products are promising to become the future treatment of different types of cancers in various organs. Superior results are being observed to come out of combination treatments with immunotherapy plus targeted products.

Exelixis is speeding its way towards proving its approved targeted product Cabometix in combination with immunotherapy products would bring the ultimate efficacy results in the treatment of cancer

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