The application was based on results observed in the pivotal, phase 3 CheckMate-9ER trial evaluating cabozantinib in combination with nivolumab compared with sunitinib in previously untreated patients with advanced or metastatic RCC.
Exelixis announced it has filed a supplemental new drug application (sNDA) with the FDA for cabozantinib (Cabometyx) in combination with nivolumab (Opdivo) for patients with advanced renal cell carcinoma (RCC).
The sNDA was based on results observed in the pivotal, phase 3 CheckMate-9ER trial evaluating cabozantinib in combination with nivolumab compared with sunitinib (Sutent) in previously untreated patients with advanced or metastatic RCC.
The open-label, randomized, multi-national phase 3 trial randomized patients 1:1 to receive either the cabozantinib-nivolumab combination or sunitinib. The primary end point was progression-free survival (PFS), and key secondary end points included overall survival (OS) and objective response rate (ORR). The primary efficacy analysis specifically is comparing the doublet combination of cabozantinib and nivolumab versus sunitinib in all randomized patients.
In April 2020, the trial met its primary end point of significantly improving PFS at final analysis, as well as the secondary endpoints of OS at a pre-specified interim analysis, and ORR. Moreover, preliminary assessment demonstrated a favorable safety profile, with a low frequency of treatment discontinuations reported due to adverse events.
“We are excited to complete our first regulatory submission for [cabozantinib] 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,” Gisela Schwab, MD, president of Product Development and Medical Affairs as well as Chief Medical Officer at Exelixis, said in a press release. “We expect that, if approved, the combination of [cabozantinib] and [nivolumab] 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.”
Detailed results from the phase 3 CheckMate-9ER trial will be presented at the upcoming European Society of Medical Oncology (ESMO) Virtual Congress 2020, during the Presidential Symposium II on September 20, 2020.
Currently, cabozantinib tablets are approved in the US for the treatment of patients with advanced RCC and for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Nexavar). In addition, cabozantinib tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide.
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 [news release]. Alameda, California. Published August 24, 2020. Accessed August 24, 2020. https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-submission-supplemental-new-drug-application