Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Beijing Cancer Hospital, Beijing, China.
Cancer Med. 2023 Feb;12(3):2666-2676. doi: 10.1002/cam4.5144. Epub 2022 Sep 2.
The global Phase III IMpower132 study evaluating atezolizumab plus pemetrexed and carboplatin or cisplatin (APP) versus pemetrexed plus carboplatin or cisplatin (PP) for first-line treatment of non-squamous advanced non-small cell lung cancer (NSCLC) met its co-primary progression-free survival (PFS) endpoint at the primary analysis in the intention-to-treat (ITT) population. Although the co-primary overall survival (OS) endpoint was not met, numerical OS improvement favoring APP over PP was observed at the final analysis. We report primary results for Chinese patients in IMpower132.
Treatment-naive Chinese patients with non-squamous stage IV EGFR/ALK mutation-negative NSCLC were randomized 1:1 to receive 4 or 6 cycles of APP or PP, followed by maintenance atezolizumab plus pemetrexed or pemetrexed. Co-primary endpoints were investigator-assessed PFS and OS.
The ITT population included 163 Chinese patients (82 in the APP arm and 81 in the PP arm). At data cutoff (median follow-up, 11.7 months), the median PFS in the APP and PP arms was 8.3 and 5.8 months, respectively; the unstratified hazard ratio (HR) was 0.73 (95% CI: 0.50, 1.08). At the interim OS analysis, median OS was not estimable in either arm; the unstratified HR was 0.70 (95% CI: 0.40, 1.24). No new safety signals were observed.
Among Chinese patients in IMpower132, PFS benefit was seen with APP versus PP. Though interim OS data were immature, there was a trend toward OS benefit favoring APP versus PP. The safety profile of the APP was consistent with the known risks of the individual treatment components.
gov: NCT02657434.
评估阿替利珠单抗联合培美曲塞和卡铂或顺铂（APP）与培美曲塞联合卡铂或顺铂（PP）一线治疗非鳞状晚期非小细胞肺癌（NSCLC）的全球 III 期 IMpower132 研究在意向治疗（ITT）人群的主要分析中达到了其共同主要无进展生存期（PFS）终点。尽管共同主要总生存期（OS）终点未达到，但在最终分析中观察到 APP 较 PP 具有数值 OS 改善。我们报告了 IMpower132 中中国患者的主要结果。
未经治疗的非鳞状 IV 期 EGFR/ALK 突变阴性 NSCLC 中国患者按 1:1 随机接受 4 或 6 个周期的 APP 或 PP，随后接受维持阿替利珠单抗联合培美曲塞或培美曲塞治疗。共同主要终点是研究者评估的 PFS 和 OS。
ITT 人群包括 163 例中国患者（APP 组 82 例，PP 组 81 例）。在数据截止时（中位随访 11.7 个月），APP 和 PP 组的中位 PFS 分别为 8.3 和 5.8 个月；未分层的风险比（HR）为 0.73（95%CI：0.50，1.08）。在中期 OS 分析中，任何一组均无法估计中位 OS；未分层的 HR 为 0.70（95%CI：0.40，1.24）。未观察到新的安全性信号。
在 IMpower132 中的中国患者中，APP 与 PP 相比，PFS 获益。尽管中期 OS 数据不成熟，但 APP 较 PP 有 OS 获益的趋势。APP 的安全性与各治疗成分的已知风险一致。
gov：NCT02657434。
