Benzinga | Aug 25, 2021 04:14PM EDT

Exelixis Announces Partner Takeda And Ono Receive Approval In Japan For CABOMETYX In Combination With OPDIVO For The Treatment Of Unresectable Or Metastatic Renal Cell Carcinoma

-- Approval based on the phase 3 CheckMate -9ER pivotal trial, which showed CABOMETYX in combination with OPDIVO improved overall survival and doubled median progression-free survival and objective response rate versus sunitinib --

Exelixis, Inc. (NASDAQ:EXEL) today announced Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX(r) (cabozantinib) in Japan, and Ono Pharmaceutical Co., Ltd. (Ono) received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market CABOMETYX in combination with OPDIVO(r) (nivolumab) as a treatment for unresectable or metastatic renal cell carcinoma (RCC).

"We're excited our partner Takeda, along with Ono, will be able to bring CABOMETYX in combination with OPDIVO to patients with advanced kidney cancer in Japan following regulatory approvals as a first-line treatment in the U.S. and EU earlier this year," said Michael M. Morrissey, Ph.D., Exelixis' President and Chief Executive Officer. "With approximately 25,000 new cases of kidney cancer diagnosed in Japan annually, we're pleased that this important new treatment option will now be available to Japanese patients in need of new therapies."

The approval is based on CheckMate -9ER, a phase 3 pivotal trial evaluating CABOMETYX in combination with OPDIVO in previously untreated patients with advanced or metastatic RCC compared with sunitinib. In CheckMate -9ER, CABOMETYX in combination with OPDIVO demonstrated superior overall survival (OS) and doubled median progression-free survival (PFS) and objective response rate (ORR) versus sunitinib, with a favorable safety profile.

Per the terms of Exelixis and Takeda's collaboration and license agreement, Exelixis is eligible to receive a milestone payment of $20 million from Takeda upon the first commercial sale of CABOMETYX in combination with OPDIVO for the treatment of RCC. Exelixis continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications and is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan.

Takeda previously received approvals to manufacture and market CABOMETYX in Japan as a treatment for patients with curatively unresectable or metastatic RCC and for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy.

About CheckMate -9ER

CheckMate -9ER is an open-label, randomized (1:1), multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic RCC with a clear cell component. A total of 651 patients (22% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L1 ?1%) were randomized to CABOMETYX at a dose of 40 mg once-daily and OPDIVO (n = 323) versus sunitinib (n = 328). The primary endpoint is PFS; secondary endpoints include OS and ORR. The primary efficacy analysis compares the doublet combination regimen of CABOMETYX and OPDIVO versus sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co. and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.