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- Title
Cabozantinib with immune checkpoint inhibitor versus cabozantinib monotherapy in patients with metastatic clear cell renal cell carcinoma progressing after prior immune checkpoint inhibitor.
- Authors
Gebrael, Georges; Jo, Yeonjung; Mathew Thomas, Vinay; Li, Haoran; Sayegh, Nicolas; Tripathi, Nishita; Srivastava, Ayana; Nordblad, Blake; Dal, Emre; Narang, Arshit; Brundage, James; Campbell, Patrick; Galarza Fortuna, Gliceida; Hage Chehade, Chadi; Maughan, Benjamin L.; Agarwal, Neeraj; Swami, Umang
- Abstract
Introduction: Rechallenge with antibodies targeting programmed cell death protein‐1 or its ligand (PD‐1/L1) after discontinuation or disease progression in solid tumors following a prior PD‐1/L1 treatment is often practiced in clinic. This study aimed to investigate if adding PD‐1/L1 inhibitors to cabozantinib, the most used second‐line treatment in real‐world patients with metastatic clear cell renal cell carcinoma (mccRCC), offers additional benefits. Methods: Using de‐identified patient‐level data from a large real‐world US‐based database, patients diagnosed with mccRCC, who received any PD‐1/L1‐based combination in first‐line (1L) setting, followed by second‐line (2L) therapy with either cabozantinib alone or in combination with PD‐1/L1 inhibitors were included. Patients given a cabozantinib‐containing regimen in 1L were excluded. The study end points were real‐world time to next therapy (rwTTNT) and real‐world overall survival (rwOS) by 2L. Results: Of 12,285 patients with metastatic renal cell carcinoma in the data set, 348 patients met eligibility and were included in the analysis. After propensity score matching weighting, cabozantinib with PD‐1/L1 inhibitors versus cabozantinib (ref.) had similar rwTTNT and rwOS in the 2L setting. Hazard ratios and 95% confidence interval (CI) for rwTTNT and rwOS are 0.74 (95% CI, 0.49–1.12) and 1.15 (95% CI, 0.73–1.79), respectively. Conclusion: In this study, the results align with the phase 3 CONTACT‐03 trial results, which showed no additional benefit of adding PD‐L1 inhibitor to cabozantinib compared to cabozantinib alone in 2L following PD‐1/L1–based therapies in 1L. These results from real‐world patients strengthen the evidence regarding the futility of rechallenge with PD‐1/L1 inhibitors. This study reports, in a large real‐world data set, that there is no survival benefit of adding a PD‐1/L1 inhibitor to cabozantinib given in a second‐line setting in patients with metastatic clear cell renal cell carcinoma with prior treatment with a PD‐1/L1 inhibitor. The real‐world data concur with the results reported in the phase 3 CONTACT‐03 clinical trial further questioning the common practice of PD‐1/L1 inhibitors rechallenge in patients with metastatic renal cell carcinoma.
- Subjects
IMMUNE checkpoint inhibitors; RENAL cell carcinoma; CLINICAL trials; PROPENSITY score matching; METASTASIS; OVERALL survival; SORAFENIB
- Publication
Cancer (0008543X), 2024, Vol 130, Issue 15, p2621
- ISSN
0008-543X
- Publication type
Article
- DOI
10.1002/cncr.35302