Cabozantinib plus nivolumab in patients with non–clear cell renal cell carcinoma: Updated results from a phase 2 trial Journal Article
| Authors: | Fitzgerald, K. N.; Lee, C. H.; Voss, M. H.; Carlo, M. I.; Knezevic, A.; Peralta, L.; Chen, Y.; Lefkowitz, R. A.; Shah, N. J.; Owens, C. N.; McHugh, D. J.; Aggen, D. H.; Laccetti, A. L.; Kotecha, R. R.; Feldman, D. R.; Motzer, R. J. |
| Article Title: | Cabozantinib plus nivolumab in patients with non–clear cell renal cell carcinoma: Updated results from a phase 2 trial |
| Abstract: | Treatment options are limited for patients with non–clear cell renal cell carcinoma (nccRCC). Patients with nccRCC experienced a favorable objective response rate (ORR) in a phase 2 trial of cabozantinib plus nivolumab. We now report updated efficacy and safety results at median follow-up of 34 mo for patients with papillary, unclassified, or translocation-associated RCC. Cabozantinib and nivolumab were administered at standard doses to patients with metastatic nccRCC that had progressed on zero or one line of systemic therapy. The primary endpoint was the ORR according to Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and adverse events. Forty patients were treated. At median follow-up of 34 mo for survivors, the ORR was 48% (95% confidence interval [CI] 31.5–63.9%). Median PFS was 13 mo (95% CI 7–16); the 12-mo and 24-mo PFS rates were 51% (95% CI 34–65%) and 23% (95% CI 11–37%), respectively. Median OS was 28 mo (95% CI 23–43); the 18-mo and 36-mo OS rates were 70% (95% CI 53–82%) and 44% (95% CI 28–60%), respectively. No new safety signals were seen with cabozantinib and nivolumab. This extended follow-up analysis demonstrates promising efficacy, and highlights the potential for sustained responses with cabozantinib plus nivolumab in patients with metastatic nccRCC. © 2024 |
| Keywords: | adult; cancer survival; clinical article; controlled study; treatment outcome; treatment response; aged; middle aged; survival rate; overall survival; clinical trial; mortality; drug dose reduction; drug efficacy; drug safety; drug withdrawal; hypertension; side effect; systemic therapy; treatment duration; pyridines; follow up; antineoplastic agent; cancer immunotherapy; progression free survival; pain; phase 2 clinical trial; antineoplastic combined chemotherapy protocols; cohort analysis; pathology; renal cell carcinoma; kidney neoplasms; cancer survivor; alanine aminotransferase blood level; aspartate aminotransferase blood level; drug dose escalation; alanine aminotransferase; aspartate aminotransferase; immunotherapy; kidney tumor; carcinoma, renal cell; kidney cancer; drug therapy; tyrosine kinase inhibitor; anilides; pyridine derivative; anilide; progression-free survival; metastatic renal cell carcinoma; clinical outcome; second-line treatment; papillary renal cell carcinoma; first-line treatment; response evaluation criteria in solid tumors; cabozantinib; combination drug therapy; nivolumab; humans; human; male; female; article; median survival time; non clear cell renal cell carcinoma; translocation renal cell carcinoma; non–clear cell renal cell carcinoma; unclassified renal cell carcinoma without papillary feature |
| Journal Title: | European Urology |
| Volume: | 86 |
| Issue: | 2 |
| ISSN: | 0302-2838 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2024-08-01 |
| Start Page: | 90 |
| End Page: | 94 |
| Language: | English |
| DOI: | 10.1016/j.eururo.2024.04.025 |
| PUBMED: | 38782695 |
| PROVIDER: | scopus |
| PMCID: | PMC11970537 |
| DOI/URL: | |
| Notes: | Article -- Erratum issued, see DOI -- 10.1016/j.eururo.2024.10.002 -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PDF; MSK corresponding author is Robert Motzer -- Source: Scopus |
