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FDA approval sought for nivolumab/cabozantinib combo in kidney cancer


The combination improved overall survival versus sunitinib in patients with previously untreated advanced RCC.

An FDA supplemental new drug application (sNDA) has been filed for the combination of nivolumab (Opdivo) and cabozantinib (Cabometyx) as a treatment for patients with advanced renal cell carcinoma (RCC).1

The sNDA is based on findings from the phase 3 CheckMate-9ER trial (NCT03141177) in which the combination of the PD-1 inhibitor and the multikinase inhibitor improved overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) compared with sunitinib (Sutent) in treatment-naïve patients with advanced RCC.2

No data from the trial have been released yet, with presentation slated for September during the 2020 European Society of Medical Oncology Virtual Congress 2020.

“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,” Gisela Schwab, MD, president, product development and medical affairs and chief medical officer, Exelixis, the manufacturer of cabozantinib, stated in a press release.

“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,” added Schwab.

Cabozantinib was approved by the FDA in December 2017 for use in previously untreated patients with advanced RCC.3 The study showed that single-agent cabozantinib in the frontline setting led to a 52% reduction in the risk of disease progression or death compared with sunitinib (HR, 0.48; P = .0008). The median PFS was 8.6 versus 5.2 months, respectively. Overall, 20% of patients responded to cabozantinib compared with 9% of patients who responded to sunitinib. The incidence of grade 3/4 adverse events (AEs) was comparable between the 2 cohorts.

The FDA approved nivolumab in November 2015 for use in patients with metastatic RCC who progressed on an angiogenesis inhibitor. The FDA made its decision based on findings from the phase 3 CheckMate-025 trial, in which the PD-1 inhibitor improved the median OS by 5.4 months versus everolimus (Afinitor), translating to a 27% reduction in the risk of death.4 The incidence of grade 3/4 AEs was lower with nivolumab versus everolimus.

Nivolumab also has an FDA-approved RCC indication in the frontline setting for use in combination with ipilimumab (Yervoy) as a treatment for intermediate- and poor-risk patients with advanced disease. The approval was supported by data from the phase 3 CheckMate-214 trial, in which the frontline combination reduced the risk of death by 37% in patients with intermediate- and poor-risk RCC.5


1.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. Published August 24, 2020. https://bit.ly/31q4RBK. Accessed August 24, 2020.

2. Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma Published April 20, 2020. https://bit.ly/2RRBItE. Accessed August 24, 2020.

3. Choueiri TK, Hessel C, Halabi S, et al. Progression-free survival (PFS) by independent review and updated overall survival (OS) results from Alliance A031203 trial (CABOSUN): Cabozantinib versus sunitinib as initial targeted therapy doe patients (pts) with metastatic renal cell carcinoma (mRCC). In: Proceedings from the 2017 ESMO Congress; September 8-12, 2017; Madrid, Spain. Abstract LBA38.

4. Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma [published online September 25, 2015]. N Engl J Med. 2015;373:1803-1813.

5. Escudier B, Tannir NM, McDermott DF, et al. CheckMate 214: Efficacy and safety of nivolumab plus ipilimumab vs sunitinib for treatment-naive advance or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups. Presented at: 2017 ESMO Congress; Madrid, Spain; September 8-12, 2017. Abstract LBA5.

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