Cabozantinib as subsequent therapy to an immune checkpoint-based therapy in renal cell carcinoma, phase 2 interventional study (AT ASIA, KCSG GU21-02)
Abstract
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Background:
Immune checkpoint inhibitors (ICIs) have significantly advanced the treatment of advanced renal cell carcinoma (aRCC). However, many patients develop disease progression, underscoring the need for effective second-line therapies. The optimal sequencing after ICI-based treatment remains under investigation. This phase II study evaluates the efficacy and safety of cabozantinib in patients with aRCC who progressed on first-line ICI combination therapies.
Methods:
This multicenter, prospective, phase II trial enrolled patients with advanced RCC who had progressed after receiving either nivolumab plus ipilimumab (Cohort 1) or a PD-1/PD-L1 inhibitor in combination with a VEGFR-TKI (e.g., pembrolizumab plus axitinib or pembrolizumab plus lenvatinib; Cohort 2). Non-clear cell histology was allowed in Cohort 2. Eligible patients were treated with cabozantinib at standard dosing. The primary endpoint was objective response rate (ORR) per RECIST 1.1 criteria. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
Results:
From September 2021 to August 2024, 88 patients (Cohort 1, n=49; Cohort 2, n=39) were enrolled across 13 institutions. The baseline International Metastatic RCC Database Consortium (IMDC) risk categories were as follows: favorable (15.9%), intermediate (71.6%), and poor (12.5%). Prior nephrectomy was reported in 42.0% of patients, and non-clear cell histology accounted for 20.5% of Cohort 2. After a median…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 49 participants or records.
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