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Therapeutics (Systemic- Radiation therapy, ablation, surgery, interventional radiology, urology, medical oncology)

48: Nivolumab plus cabozantinib (NIVO+CABO) versus sunitinib (SUN) for first-line treatment of advanced renal cell carcinoma (aRCC): 3-year follow-up from the phase 3 CheckMate 9ER trial

Background: In CheckMate 9ER, first-line NIVO+CABO demonstrated superiority over SUN with 25.4 months minimum follow-up (median, 32.9 months) in patients with aRCC. We report survival, response per blinded independent central review (BICR), and safety after 3 years minimum follow-up in all randomized patients and by IMDC risk score.

Methods: Patients were randomized 1:1 (stratified by IMDC risk score, tumor PD-L1 expression, region) to NIVO 240 mg Q2W plus CABO 40 mg QD versus SUN 50 mg QD for 4 weeks (6-week cycles) until disease progression/unacceptable toxicity (maximum NIVO treatment, 2 years). Primary endpoint: progression-free survival (PFS) by BICR. Secondary endpoints: overall survival (OS), objective response rate (ORR) by BICR, and safety.

Results: 323 patients were randomized to NIVO+CABO and 328 to SUN. With 36.5 months minimum follow-up (median, 44.0 months), efficacy benefits were maintained with NIVO+CABO versus SUN in intent-to-treat patients. Median PFS was 16.6 versus 8.4 months, median OS was 49.5 versus 35.5 months, ORR was 56% versus 28% (Table), and median duration of response was 22.1 versus 16.1 months, respectively. PFS, OS, and response are reported across IMDC risk groups in the Table. Any-grade (grade ≥3) treatment-related adverse events occurred in 97% (67%) versus 93% (55%) of patients treated with NIVO+CABO versus SUN.

Conclusions: After extended follow-up, efficacy benefits were maintained with NIVO+CABO. Median OS with NIVO+CABO improved by 11.8 months since the previous data cut. Responses with NIVO+CABO were durable, with higher complete response rates with NIVO+CABO versus SUN regardless of IMDC risk. No new safety signals emerged. These results continue to support NIVO+CABO as a first-line treatment for aRCC. Previously presented at the ASCO GU 2023 Annual Meeting, all rights reserved, and CITIM 2023.