Manojkumar Bupathi, MD, MS, discusses the updated efficacy results of the CheckMate 9ER trial of cabozantinib plus nivolumab for patients with previously untreated advanced clear cell renal cell carcinoma.
Manojkumar Bupathi, MD, MS, medical oncologist at Rocky Mountain Cancer Centers, discusses the updated efficacy results of the CheckMate 9ER trial (NCT03141177) of cabozantinib (Cabometyx) plus nivolumab (Opdivo) for patients with previously untreated advanced clear cell renal cell carcinoma (RCC).
The phase 3 CheckMate 9ER trial randomly assigned patients with RCC to receive either cabozantinib plus nivolumab or sunitinib (Sutent). For those who received cabozantinib/nivolumab, the objective response rate (ORR) was 55.7%, with a complete response (CR) rate of 12.4%, versus a 28.4% ORR and 5.2% CR rate with sunitinib. The median duration of response (DOR) for cabozantinib/nivolumab was 23.1 months compared with 15.1 months with sunitinib.
At a median follow-up of 32.9 months reported in February 2022, median overall survival (OS) for cabozantinib/nivolumab was 37.7 months versus 34.3 months OS with sunitinib (HR, 0.70; 95% CI, 0.55-0.90). Median progression-free survival (PFS) was 16.6 months for cabozantinib/nivolumab versus 8.3 months with sunitinib (HR, 0.56; 95% CI, 0.46-0.68).
Bupathi says that cabozantinib alone was initially approved as second-line therapy and showed benefit in that setting. However, the frontline combination with immunotherapy now shows clear benefit across all International Metastatic RCC Database Consortium (IMDC) risk groups.
0:08 | [CheckMate 9ER] was a phase 3 randomized study, which was using nivolumab plus cabozantinib versus sunitinib. The median follow-up in this study was 32.9 months. The median OS was 37.7 months in the combination of nivolumab and cabozantinib versus 34.3 months with sunitinib. The median PFS was improved with nivolumab and cabozantinib at 16.6 months versus 8.3 months with sunitinib. The ORR was 55.7%, the CR rate was 12.4%, the median time to response was 2.8 months, and the median DOR was 23.1 months.
0:58 | Cabozantinib was initially approved [as] second-line therapy after immunotherapy, which achieved similar outcomes. When you use the combination of cabozantinib plus nivolumab in first-line therapy regardless of IMDC criteria, there seems to be a benefit across all groups of patients.