Efficacy and safety of sintilimab in combination with chemotherapy in previously untreated advanced or metastatic nonsqu
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CLINICAL TRIAL REPORT
Efficacy and safety of sintilimab in combination with chemotherapy in previously untreated advanced or metastatic nonsquamous or squamous NSCLC: two cohorts of an open‑label, phase 1b study Haiping Jiang1 · Yulong Zheng1 · Jiong Qian1 · Chenyu Mao1 · Xin Xu1 · Ning Li1 · Cheng Xiao1 · Huan Wang1 · Lisong Teng2 · Hui Zhou3 · Shuyan Wang3 · Donglei Zhu3 · Tao Sun4,5 · Yingying Yu4 · Wenying Guo4 · Nong Xu1 Received: 25 May 2020 / Accepted: 2 October 2020 © The Author(s) 2020
Abstract Combining chemotherapy with immunotherapy improves the therapeutic outcome for first-line (1L) patients with advance nonsmall-cell lung cancer (NSCLC). Two cohorts of a phase 1b study (NCT02937116) aimed to evaluate the safety and efficacy of sintilimab, a PD-1 inhibitor, plus chemotherapy in 1L patients with nonsquamous and squamous NSCLC (nsqNSCLC/sqNSCLC); and to identify potential biomarkers for treatment response. Treatment-naïve patients with nsqNSCLC were enrolled and intravenously given sintilimab (200 mg), pemetrexed (500 mg/m2), and cisplatin (75 mg/m2), every 3 weeks (Q3W) for 4 cycles in cohort D. Treatment-naïve patients with sqNSCLC were enrolled and intravenously given sintilimab (200 mg), gemcitabine (1250 mg/m2), and cisplatin (75 mg/m2), Q3W, for 6 cycles in cohort E. The primary objective was to evaluate the safety and efficacy of the treatment. The additional objective was to explore biomarkers for the treatment efficacy. Twenty-one patients with nsqNSCLC, and 20 patients with sqNSCLC were enrolled in cohort D and cohort E, respectively. By the data cutoff (April 17, 2019), 8 (38.1%) patients in cohort D and 17 (85.0%) patients in cohort E experienced grade 3–4 adverse events. The median follow-up duration was 16.4 months (14.8–23.0) in cohort D and 15.9 months (11.7–17.7) in cohort E. The objective response rate was 68.4% (95% CI 43.4%, 87.4%) in cohort D and 64.7% (95% CI 38.3%, 85.8%) in cohort E. Neither PD-L1 expression nor tumor mutation burden value was significantly associated with an improved treatment response. Sintilimab plus chemotherapy exhibited manageable toxicity and an encouraging antitumor activity in patients with nsqNSCLC and sqNSCLC. Keywords Sintilimab · NSCLC · First line · TCR · TMB
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00262-020-02738-x) contains supplementary material, which is available to authorized users. * Nong Xu [email protected] 1
Department of Medical Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, No. 79 Qingchun Road, Hangzhou 310003, China
2
Department of Surgical Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China
3
Department of Medical Science and Strategy Oncology, Innovent Biologics, Inc, Suzhou, China
4
Hangzhou ImmuQuad Biotechnologies, Hangzhou, China
5
Zhejiang‑California International NanoSystems Institute, Zhejiang University, Hangzhou, China
Abbreviation AEs Adverse events ALK Anapl
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