- Starting treatment with nivolumab (NIVO) alone, and giving ipilimumab (IPI) as immunotherapeutic boost in nonresponders, improves response compared with nivolumab monotherapy.
Why this matters
- NIVO+IPI has been approved for the first-line treatment of intermediate and poor risk advanced renal cell carcinoma (RCC), but administering the combined treatments in a fixed regimen with four induction cycles may result in more adverse events than nivolumab alone.
- This is the first study to assess a tailored approach to boosting NIVO treatment with IPI based on individual response.
- Phase 2, multicentre European study in 258 first- and second-line patients after tyrosine kinase inhibitor (TKI) with International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk advanced clear-cell RCC.
- Patients who did not respond to induction with single-agent nivolumab received 2-4 boost cycles of NIVO+IPI.
- Patients who responded to induction continued with NIVO maintenance, and received the IPI boost only if they progressed.
- The primary endpoint was investigator-assessed overall response rate (ORR), analysed independently in first- and second-line.
- Funding: Bristol-Myers Squibb GmbH & Co. KGaA.
- ORR with NIVO monotherapy was 28.7% (95% CI 20-38) in first-line patients and 18.2% in second-line.
- Best overall response after NIVO induction with or without NIVO+IPI boosts was 37% (95% CI 28-47) in first-line and 28.3% (95% CI 20-38) in second-line.
- Longer follow-up is needed to assess duration of response.
- "The boost strategy could rescue about 10% of patients compared with NIVO alone," said discussant Dr Cristina Suarez, MD PhD, Vall d’Hebron Institute of Oncology, Spain, who was not involved in the study. "However, some patients may miss out on the benefits of receiving IPI. CR rates with the strategy in first-line were lower than with combination therapy," she noted. “This seems a good strategy for second-line, but not for first-line,” she concluded.