• PLT-CT后,晚期SCLC患者预后不良且治疗方式受限;
  • CheckMate 032研究采用nivo±ipi治疗后,对SCLC的耐受和疗效;
  • nivo 单药治疗(3mg/kg;n = 98),nivo + ipi联合治疗 (nivo 1 mg/kg和ipi 3 mg/kg;n = 61);
  • 延长随访后,主要终点ORR:nivo 组(11%)、nivo + ipi组(25%),3-4级AE:nivo 组(14%)、nivo + ipi组(33%);
  • 缓解率与患者对PLT耐药或敏感、还是PD-L1表达与否均无关,nivo±ipi观察到了持久的反应,同之前的治疗相同。

Nivolumab (nivo) ± ipilimumab (ipi) in advanced small-cell lung cancer (SCLC): First report of a randomized expansion cohort from CheckMate 032

一个CheckMate 032研究随机扩展队列的首次报告:采用Nivolumab (nivo) ± ipilimumab (ipi)策略治疗晚期小细胞肺癌(SCLC)


Abstract & Authors:展开

Background: Patients (pts) with advanced SCLC after first-line platinum-based chemotherapy (PLT-CT) have a poor prognosis and limited treatment options. CheckMate 032 is a phase I/II trial evaluating multiple regimens of nivo ± ipi in solid tumors, including advanced SCLC. Tolerability and efficacy of nivo ± ipi were demonstrated in early results from the initial treatment arms (Antonia, Lancet Oncol 2016), prompting long-term follow-up and the addition of a randomized expansion cohort to further evaluate nivo ± ipi in advanced SCLC.
Methods: In the initial treatment arms, pts with advanced SCLC and disease progression after prior PLT-CT were assigned to nivo (3 mg/kg Q2W; n = 98) or nivo 1 + ipi 3 (1 mg/kg and 3 mg/kg Q3W x 4, then nivo 3 Q2W; n = 61); safety/efficacy was assessed with a follow-up of ~18 mo. In the subsequent SCLC expansion cohort, pts were randomized 3:2 to nivo vs nivo 1 + ipi 3 and stratified by number of prior therapies. The primary endpoint was objective response rate (ORR).
Results: Updated efficacy/safety results from the initial (non-randomized) nivo and nivo 1 + ipi 3 arms are summarized in the table. Responses were durable and occurred regardless of PD-L1 expression or PLT-sensitivity; safety was consistent with prior nivo ± ipi studies. In the expansion cohort, 247 pts were randomized to nivo or nivo 1 + ipi 3. The presentation will contain the first report of efficacy/safety results and subgroup analyses from this randomized expansion cohort.
Conclusions: Durable responses are observed with nivo and nivo + ipi in pts with previously treated SCLC. The expansion cohort represents the first randomized evaluation of combined immune checkpoint blockade in SCLC.

All Authors:
Matthew David Hellmann