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.
Highlights
Lung cancer is the leading cause of cancer-related mortality worldwide [1]
Our phase 1b study preliminarily suggested that sintilimab-chemo had a tolerable safety profile and may improve tumor response in 1L advanced patients with nsq/sqNSCLC
Most frequent adverse events (AEs) for the combination therapy in two cohorts were nonhematological, such as nausea (42.9%) which was comparable to historical data of pembrolizumab- or nivolumab-chemo (29–56%) in advanced patients with Nonsmall-cell lung cancer (NSCLC) [5, 6, 23]
Summary
Lung cancer is the leading cause of cancer-related mortality worldwide [1]. Nonsmall-cell lung cancer (NSCLC) represents 85% of the diagnosed lung cancer cases [2], and approximately 70% of the patients with NSCLC are nonsquamous at a diagnosis stage [3].Platinum-based chemotherapy is the standard treatment for 1L advanced patients with NSCLC lacking targetable mutations [4, 5]. Lung cancer is the leading cause of cancer-related mortality worldwide [1]. Nonsmall-cell lung cancer (NSCLC) represents 85% of the diagnosed lung cancer cases [2], and approximately 70% of the patients with NSCLC are nonsquamous at a diagnosis stage [3]. Platinum-based chemotherapy is the standard treatment for 1L advanced patients with NSCLC lacking targetable mutations [4, 5]. The immunogenic properties of chemotherapies make it possible to combine chemotherapy with immunotherapy [6]. Pembrolizumab combining with platinum-based doublet chemotherapy (PT-DC) has shown an encouraging antitumor activity and manageable toxicity for 1L advanced NSCLC [5, 7]
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