Consolidation ipilimumab and nivolumab in limited stage SCLC

The STIMULI trial showed no improvement in progression-free survival (PFS) with nivolumab plus ipilimumab consolidation therapy versus observation after chemoradiotherapy in limited stage small cell lung cancer (SCLC).

Concurrent chemoradiotherapy (CRT) followed by prophylactic cranial irradiation (PCI) is the standard strategy in limited stage SCLC. In the phase 2 STIMULI trial, 153 patients were 1:1 randomised after completion of CRT and PCI to consolidation therapy (4 cycles of nivolumab 1 mg/kg every 3 weeks plus ipilimumab 3 mg/kg every 3 weeks, followed by nivolumab monotherapy 240 mg every 2 weeks for up to 12 months) or observation [1].

Median PFS in the nivolumab/ipilimumab arm was 10.7 months versus 14.5 months in the observation arm (HR 1.02; P=0.93). Two-year PFS rate was 43% and 40%, respectively. Median overall survival (OS) was not reached in the nivolumab/ipilimumab arm, while it was 31.6 months in the observation arm (HR 1.06; P=0.83). One-year OS rate was 79% and 89%, respectively. However, 3-year OS rate was 53% in the nivolumab/ipilimumab arm versus 41% in the observation arm. Therefore, a longer follow-up will allow the exploration of possible late effect of immunotherapy consolidation on survival.

1. Peters S, et al. Consolidation ipilimumab and nivolumab vs observation in limited stage SCLC after chemo-radiotherapy: Results from the ETOP/IFCT 4-12 STIMULI trial. ESMO 2020 Virtual Meeting, abstract LBA84.

Posted on 25 November 202025 March 2024