55 month follow up of CheckMate 9ER trial

Prof Emmanual Seront, medical oncologist at Cliniques Universitaires Saint-Luc, guides us through the update of the CheckMate 9ER trial that was presented at ASCO GU 2024.

This well-known randomized phase 3 trial assesses the efficacy of combining nivolumab and cabozantinib (NIVO+CABO) versus sunitinib (SUN) as the first-line treatment for metastatic RCC. The primary endpoint is PFS, with secondary endpoints including OS, ORR, and safety. Exploratory endpoints are health-related QoL.

Preliminary results have already indicated a benefit for the primary endpoint and at ASCO GU 2024, data with a median follow-up of 55 months were presented, providing additional evidence to support the efficacy of the NIVO+CABO treatment.

In the ITT population, stratified by intermediate risk, poor risk, and favourable risk groups, the combination improved PFS, ORR, and OS across all categories. Notably, for intermediate and poor risk groups, NIVO+CABO demonstrated significant improvements in terms of PFS (doubling), ORR (doubling), and median OS (an absolute increase of 15 months).

In favourable risk groups, while NIVO+CABO enhanced PFS and ORR, no substantial difference in OS was observed, suggesting that further observation may be warranted. However, the noteworthy result lies in the ORR, with a 66% ORR observed in the NIVO+CABO treatment versus 44% in the SUN group. CRR was also higher with NIVO+CABO, showing a 16% increase. This indicates the combination’s notable efficacy in achieving a robust response in this patient cohort.

Furthermore, the median time to achieve response was significantly shorter in the NIVO+CABO group, at 2.8 months compared to 4.7 months in the SUN group. Thus, the overarching message is that once a response is achieved, it tends to be more durable across all subgroups. QoL measurements indicate that the NIVO+CABO regimen is superior to SUN.

Considering these findings, it is reasonable to conclude that the combination of NIVO+CABO should be considered for the treatment of metastatic RCC patients.

References:

Bourlon MT et al, 2024, Nivolumab plus cabozantinib (N+C) vs sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Results from 55-month follow-up of the CheckMate 9ER trial. ASCO GU 2024 #362

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