FDA Accepts Opdivo, Cabometyx Combo’s Priority Review Applications

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for about 90% of cases and causing over 140,000 deaths worldwide each year. The disease rate of RCC is highest in North America and Europe with no identified cure so far. If patients are detected early, the five-year survival rate is high, but it decreases to 12% when diagnosed with advanced or late-stage metastatic RCC.

On October 19th, Bristol Myers Squibb (BMS) and a genomics-based drug discovery company Exelixis, announced that they received the USFDA acceptance of the supplemental Biologics License Application (sBLA) and supplemental New Drug Application (sNDA) respectively for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for patients with advanced renal cell carcinoma. The USFDA granted Priority Review to both applications and assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 20, 2021.

“We have witnessed practice-changing advancements in the treatment of renal cell carcinoma in recent years, but we recognize the importance of providing patients and physicians with additional options that can help them take control of the disease,” said Mark Rutstein, Vice President, Development Program Lead, BMS. “Combining OPDIVO and CABOMETYX, two proven agents with strong clinical legacies in advanced renal cell carcinoma, led to superior efficacy across all endpoints. We look forward to working with the FDA to bring this potential treatment option to physicians and their patients who choose immunotherapy plus tyrosine kinase inhibitor regimen.”


Opdivo-Cabometyx Combo

Opdivo is the first programmed death-1 (PD-1) immune checkpoint inhibitor to receive regulatory approval worldwide since July 2014. Opdivo is currently approved in over 65 countries, including the U.S., the European Union, Canada, and Japan. It harnesses the body’s own immune system by restoring anti-tumor immune response, and thus Opdivo has become an important treatment option across multiple cancers. For example, BMS’s Opdivo and Yervoy combination regimen was the first immuno-oncology combination to receive regulatory approval for the treatment of metastatic melanoma, and this treatment has been approved in more than 50 countries.

Developed by Exelixis, Cabometryx tablets have been granted approvals in many countries and given exclusive rights to many giant pharma. The US approved patients with advanced RCC or with hepatocellular carcinoma (HCC) to be treated with Cabometyx. Cabometyx has also obtained approval in the European Union, Japan, and many other countries worldwide. For instance, Exelixis granted Ipsen exclusive rights for the commercialization and future clinical study of Cabometyx outside of the US and Japan in 2016. In 2017, Exelixis authorized Takeda Pharmaceutical Company Limited the exclusive rights to commercialize and be in charge of Cabometyx clinical trials for all future indications in Japan.

“With their complementary mechanisms of action and evidence that CABOMETYX may promote a more immune-permissive environment, we believe there is (an) opportunity for additive or synergistic effects with this potential combination regimen,” said Gisela Schwab, M.D., president, product development and medical affairs and chief medical officer, Exelixis.


Phase 3 Clinical Trial

The USFDA review will be based on results from the Phase 3 CheckMate-9ER trial that examines the efficacy of the Opdivo and Cabometyx combo in patients with previously untreated advanced RCC versus sunitinib. Sunitinib, created by Pfizer and approved by the USFDA 14 years ago, is an oral, small molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor to treat RCC and imatinib-resistant gastrointestinal stromal tumor.

CheckMate-9ER is an open-label, randomized, multinational clinical trial that is sponsored by BMS and Ono Pharmaceutical Company as well as co-founded by Exelixis, Ipsen, and Takeda Pharmaceuticals. The trial demonstrated that the combo indicated significant improvements over sunitinib across all efficacy indications, such as overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).

The Opdivo and Cabometyx combo reduced the risk of death by 40% and had met several primary endpoints. The median PFS was 16.6 months for the combo versus 8.3 months for sunitinib, the combo exactly doubling the length of time for the previous treatment. The ORR was also twice the rate of sunitinib (27%) than that of the combo (56%) and achieved an 8% complete response with the combo versus 5% with sunitinib.

The duration of response was almost double in time with sunitinib than in that with the combo, 11.5 months versus 20.2 months. Besides, patients showed better adaptation to the combo because of a significantly lower rate of treatment discontinuation, 44.4% versus sunitinib 71.3%, and a lower rate of drop-out due to disease progression, 27.8% versus 48.1%. All the efficacy results were in a line across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 subgroups.

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