ESMO 2025: Efficacy of Cabozantinib and Nivolumab in Cluster 1/2 Metastatic Clear Cell Renal Cell Carcinoma: Results from OPTIC RCC, a Phase II Trial of a Novel RNAseq-based Biomarker
Cabozantinib plus nivolumab achieved an overall response rate of 76% in cluster 1/2 metastatic clear cell renal cell carcinoma, meeting the primary endpoint of the OPTIC RCC phase II trial.
The OPTIC RCC phase II trial evaluated cabozantinib plus nivolumab in patients with metastatic clear cell renal cell carcinoma (ccRCC) whose tumors exhibited an angiogenic gene expression signature (cluster 1/2). A total of 27 patients were treated, achieving an overall response rate (ORR) of 76% (CR 8%, PR 68%) and no progressive disease. The study demonstrates that RNA‑seq biomarker-guided selection of angiogenic‑signature ccRCC patients can enrich for clinical benefit from combined anti‑angiogenic and immune checkpoint blockade.
This study shows that a tumor‑based RNA‑seq biomarker can identify ccRCC patients most likely to respond to cabozantinib + nivolumab, potentially improving personalized treatment and outcomes in this heterogenous disease group.
Evidence level: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.
Related signals
- Prognostic Value of the Modified Glasgow Prognostic Score in Patients with Metastatic Renal Cell Carcinoma Receiving Nivolumab as Second-Line Therapy
- A Review of Immunotherapy in Renal Cell Carcinoma: Current Landscape and Future Directions
- EAU 2025: State-of-the-Art Lecture: Neoadjuvant Strategies in Locally Advanced Renal Cancer
- Early detection of renal cell carcinoma: a novel cell-free DNA fragmentomics‑based liquid biopsy assay
- Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)