SCI

15 July 2024

Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small cell lung cancer: A proof-of-concept, phase 2 trial

(Cancer Cell, IF: 48.8)

  • Qing Zhou, Yi Pan, Xuening Yang, Yanqiu Zhao, Guang Han, Qingsong Pang, Zhenfa Zhang, Qifeng Wang, Jun Yao, Hui Wang, Weihua Yang, Baogang Liu, Qixun Chen, Xianghui Du, Kaican Cai, Baosheng Li, Yunchao Huang, Xiao Li, Li Song, Wei Shi, and Yi-Long Wu

  • CORRESPONDENCE TO: syylwu@live.cn

SUMMARY 摘要

We conducted a proof-of-concept, phase 2 trial to assess neoadjuvant SHR-1701 with or without chemotherapy, followed by surgery or radiotherapy, and then consolidation SHR-1701 in unresectable stage III non-small-cell lung cancer (NSCLC). In the primary cohort of patients receiving neoadjuvant combination therapy (n = 97), both primary endpoints were met, with a post-induction objective response rate of 58% (95% confidence interval [CI] 47–68) and an 18-month event-free survival (EFS) rate of 56.6% (95% CI 45.2–66.5). Overall, 27 (25%) patients underwent surgery; all achieved R0 resection. Among them, 12 (44%) major pathological responses and seven (26%) pathological complete responses were recorded. The 18-month EFS rate was 74.1% (95% CI 53.2–86.7) in surgical patients and 57.3% (43.0–69.3) in radiotherapy- treated patients. Neoadjuvant SHR-1701 with chemotherapy, followed by surgery or radiotherapy, showed promising efficacy with a tolerable safety profile in unresectable stage III NSCLC. Surgical conversion was feasible in a notable proportion of patients and associated with better survival outcomes.

我们进行了一项概念验证的2期试验，以评估应用新辅助药物SHR-1701有无联合化疗，然后进行手术或放疗，然后再应用SHR-1701巩固治疗不可切除的III期非小细胞肺癌（NSCLC）。在接受新辅助联合治疗的患者的主要队列中（n=97），两个主要终点都得到了满足，诱导后客观有效率为58%（95%置信区间[CI]47-68），18个月无事件生存率（EFS）为56.6%（95%CI 45.2-66.5）。总体而言，27名（25%）患者接受了手术；均实现R0切除。其中，有12例（44%）患者达到了主要病理反应、7例（26%）患者达到了完全病理反应。手术患者18个月EFS发生率为74.1%（95%CI 53.2–86.7），放疗患者为57.3%（43.0–69.3）。在不可切除的III期非小细胞肺癌中，新辅助SHR-1701联合化疗、手术或放疗显示出良好的疗效和可耐受的安全性。手术转换在相当大比例的患者中是可行的，并且与更好的生存结果相关。