- Dual checkpoint inhibition with nivolumab+ipilimumab improves survival and response in patients with advanced renal cell carcinoma (RCC) with sarcomatoid features vs sunitinib monotherapy.
- OS improved regardless of programmed death-ligand 1 (PD-L1) expression.
Why this matters
- Patients with sarcomatoid features have poor prognosis.
- Post hoc analysis of the phase 3 CheckMate 214 trial.
- 139 patients with advanced RCC with sarcomatoid features were randomly assigned to nivolumab plus ipilimumab or sunitinib monotherapy.
- Funding: Bristol Myers Squibb.
- Minimum follow-up was 42 months.
- Median OS significantly improved in the nivolumab+ipilimumab group:
- Not reached vs 14.2 months with sunitinib;
- HR, 0.45 (P=.0004).
- PFS benefits with nivolumab+ipilimumab also seen:
- Median, 26.5 vs 5.1 months with sunitinib;
- HR, 0.54 (P=.0093).
- Nivolumab+ipilimumab vs sunitinib:
- Confirmed overall response rate: 60.8% vs 23.1%;
- Complete response rate: 18.9% vs 3.1%.
- OS improved with nivolumab+ipilimumab regardless of baseline PD-L1 expression:
- Expression ≥1%: HR, 0.42 (P=.0260);
- Grade 3-4 adverse event rate was 49% with nivolumab+ipilimumab vs 45% with sunitinib.
- No new safety signals were reported.
- Limited power to detect differences according to baseline PD-L1 expression.