In an August 24, 2020 press release, the submission of a supplemental New Drug Application (sNDA) to the FDA for cabozantinib (Cabometyx) in combination with nivolumab (Opdivo) for the treatment of patients with advanced renal cell carcinoma (RCC) was announced. The sNDA submission was based on the results of the pivotal, phase III CheckMate-9ER trial evaluating cabozantinib in combination with nivolumab compared with sunitinib in previously untreated patients with advanced or metastatic RCC. The CheckMate -9ER is an open-label, randomized, multinational phase III trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma. 

Patients were randomized 1:1 to nivolumab and cabozantinib versus sunitinib. The primary endpoint was progression-free survival (PFS). Secondary endpoints include overall survival (OS) and objective response rate (ORR). The primary efficacy analysis compares the double combination of cabozantinib and nivolumab versus sunitinib in all randomized patients. 

In an April 20, 2020 press release, the manufacturer announced that the trial met its primary endpoint of considerably enhancing progression-free survival at final analysis, as well as the secondary endpoints of OS at a prespecified interim analysis, and ORR. Preliminary assessment demonstrated a positive safety profile, with a low frequency of treatment discontinuations due to adverse events. 

In a statement, Gisela Schwab, MD, president, product development and medical affairs and chief medical officer of Exelixis stated, “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. 

“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,” Dr. Schwab added.

Additionally, the manufacturer indicates that the complete results of CheckMate-9ER will be presented during the upcoming European Society of Medical Oncology Virtual Congress 2020, during Presidential Symposium II on September 20, 2020. More information about this trial is available at

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