- Submission based on the phase 3 pivotal CheckMate -9ER trial, which met its primary endpoint of significantly improving progression-free survival and secondary endpoints of overall survival and objective response rate
San Francisco, CA (UroToday.com) -- Exelixis, Inc. announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC).
“We are excited to complete our first regulatory submission for CABOMETYX in combination with an immune-checkpoint inhibitor based on the positive results from the CheckMate -9ER phase 3 pivotal trial, which showed a statistically significant and clinically meaningful benefit in the key efficacy measures of progression-free survival, overall survival and objective response rate for patients with previously untreated kidney cancer,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis.“We expect that, if approved, the combination of CABOMETYX and Opdivo will be an important new first-line treatment regimen for RCC patients who need additional therapeutic options that extend survival. We look forward to continuing to work closely with Bristol Myers Squibb and the FDA through the regulatory review process.”
The sNDA is based on the results of CheckMate -9ER, a phase 3 pivotal trial evaluating CABOMETYX in combination with Opdivo compared with sunitinib in previously untreated patients with advanced or metastatic RCC. Exelixis and Bristol Myers Squibb announced in April 2020 that the trial met its primary endpoint of significantly improving progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR). Preliminary assessment showed a favorable safety profile, with a low frequency of treatment discontinuations due to adverse events. The detailed results of CheckMate -9ER will be presented during the upcoming European Society of Medical Oncology (ESMO) Virtual Congress 2020, during Presidential Symposium II on September 20, 2020. More information about this trial is available at ClinicalTrials.gov.
About CheckMate -9ER
CheckMate -9ER is an open-label, randomized, multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma. Patients were randomized 1:1 to Opdivo and CABOMETYX or sunitinib. The primary endpoint is PFS. Secondary endpoints include OS and ORR. The primary efficacy analysis compares the doublet combination of cabozantinib and nivolumab 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.
Source: WIRE, BUSINESS. 2020. "Exelixis Announces Submission Of Supplemental New Drug Application To U.S. Food And Drug Administration For CABOMETYX® (Cabozantinib) In Combination With Opdivo® (Nivolumab) For Advanced Renal Cell Carcinoma". Businesswire.Com.