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Therapeutics- Systemic (Ablation, Interventional Radiology, Medical Oncology, Radiation Therapy, Surgery, Urology)

38: Association between depth of response (DepOR) and clinical outcomes: exploratory analysis in patients with previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 9ER

Location: Poster Hall, Board D6

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Poster Presenter(s)

Andrea B. Apolo, MD

Medical Oncologist
Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD
Bethesda, MD, United States

Alternate Presenter(s)

Bernard Escudier, MD

Institut Gustave-Roussy, France

Background: Among patients with untreated aRCC in CheckMate 9ER, superior progression-free survival (PFS; HR, 0.56) and overall survival (OS; HR, 0.70) were maintained, and objective response and complete response (CR) rates were doubled for nivolumab plus cabozantinib (NIVO+CABO) versus sunitinib (SUN) with extended 25.4-month minimum (32.9-month median) follow-up. This exploratory analysis evaluated DepOR and clinical outcomes in CheckMate 9ER.

Methods: Patients received NIVO (240mg) every 2 weeks plus CABO (40mg) once daily or SUN (50mg once daily; 4 weeks; 6-week cycles). DepOR subgroups were based on best overall response (blinded independent central review [BICR], RECIST v1.1) and best tumor reduction thresholds (CR; partial response subdivided by tumor reduction of ≥80% [PR1]; ≥60%- < 80% [PR2]; or < 60% [PR3]; stable disease; and progressive disease). PFS (per BICR) and OS by DepOR subgroups were analyzed after a 6-month post-randomization landmark. Treatment-related adverse events (TRAEs) were also assessed.

Results: Of patients randomized to NIVO+CABO or SUN, at the 6-month landmark 236/323 and 157/328 were progression-free and alive and 293/323 and 253/328 were alive and categorized by DepOR subgroup. Greater proportions of patients receiving NIVO+CABO had deeper responses versus SUN (CR, PR1, PR2; Table). Deeper responses with NIVO+CABO were associated with improved 12-month PFS rates versus SUN for CR (94.9% vs 82.4%), PR1 (81.3% vs 37.5%), and PR2 (72.1% vs 53.2%). Increasingly deeper responses led to better OS outcomes overall; yet OS rates and medians were comparable between arms for CR and PR1-3 (Table). No meaningful patterns for overall TRAEs by subgroup were identified.

Conclusions: More patients achieved deeper responses with NIVO+CABO versus SUN and deeper responses were generally associated with improved PFS and OS.
Previously presented at the ASCO 2022 Annual Meeting. All rights reserved.