Abstract CT083: Camrelizumab plus apatinib in extensive-stage small-cell lung cancer (PASSION): A multicenter, two-stage, phase 2 trial
Authors: Wang Jie , Fan Yun , Zhao Jun , Wang Qiming , Huang Dingzhi , Li Xingya , Chen Jianhua , Fang Yong , Wang Zhijie , Zhou Caicun , Hu Yanping , Yang Haihua , Hu Yi , Zhou Jianying , Lin Xiaoyan , Wang Lifeng , Xu Yanjun , Li Hanying 
Published: September 2020

Abstract
Background: Treatment options in 2nd-line extensive-stage small-cell lung cancer (ED-SCLC) setting are very limited. PASSION (NCT03417895) was a phase 2 study of camrelizumab plus apatinib in ED-SCLC after platinum-based chemotherapy. Methods: In the randomized, open-label, three-parallel-cohort Stage 1, patients (pts) were randomly assigned (1:1:1) to receive intravenous camrelizumab 200 mg every 2 weeks plus oral apatinib 375 mg once daily (QD), 5 days on/2 days off, or 7 days on/7 days off (six pts each cohort). Based on the tolerability during the first 28-day cycle and efficacy data in Stage 1, one cohort was chosen to expand to 45 pts in Stage 2. The primary endpoints were objective response rate (ORR) per RECIST 1.1 and safety. Results: From Apr 20, 2018 to Mar 12, 2019, 59 pts were enrolled, with 47 in the QD cohort. Findings as of Dec 12, 2019 are listed in the table. In the QD cohort, confirmed ORR reached 34.0% (95% CI 20.9-49.3), median progression-free survival (PFS) was 3.6 months (95% CI 1.9-4.6), and median overall survival (OS) was 8.4 months (95% CI 4.7-12.3). Chemo-sensitive and chemo-resistant pts (defined as pts with disease relapsed ≥90 and &lt;90 days after platinum based chemo, respectively) had comparable confirmed ORR (37.5% vs 32.3%), median PFS (3.6 vs 2.7 months), and median OS (9.6 vs 8.0 months). Treatment-related adverse events (TRAEs) of grade ≥3 were reported in 43 (72.9%) of all 59 pts, with the most common being hypertension (25.4%), hand-foot syndrome (13.6%), and decreased platelet count (13.6%). These reported adverse events were manageable. Five (8.5%) pts discontinued treatment due to TRAEs. No treatment related death was reported. Conclusions: Camrelizumab plus apatinib showed potent antitumor activity in both chemo-sensitive and chemo-resistant ED-SCLC pts after platinum-based chemotherapy with acceptable toxicity profile. This phase 2 data warrant further clinical studies of camrelizumab plus apatinib in SCLC.
Table.Summary of clinical efficacy.Camrelizumab plus apatinib (QD) (n = 47)Camrelizumab plus apatinib (5 days on/2 days off) (n = 6)Camrelizumab plus apatinib (7 days on/7 days off) (n = 6)All patients (n = 59)Objective response rate, n (%) 95% CI16 (34.0) 20.9−49.32 (33.3) 4.3−77.72 (33.3) 4.3−77.720 (33.9) 22.1−47.4Median duration of response, months (95% CI)6.2 (3.7−9.2)4.2 (3.6−4.7)NR (4.6−NR)5.7 (3.7−8.6)Disease control rate, n (%) 95% CI32 (68.1) 52.9−80.96 (100.0)3 (50.0) 11.8−88.241 (69.5) 56.1−80.8Median progression-free survival, months (95% CI)3.6 (1.9−4.6)3.6 (2.7−8.3)1.2 (0.9−NR)2.8 (1.9−4.6)Median overall survival, months (95% CI)8.4 (4.7−12.3)11.2 (4.9−NR)5.4 (1.5−NR)8.4 (5.4−11.2)NR, not reached
Citation Format: Jie Wang, Yun Fan, Jun Zhao, Qiming Wang, Dingzhi Huang, Xingya Li, Jianhua Chen, Yong Fang, Zhijie Wang, Caicun Zhou, Yanping Hu, Haihua Yang, Yi Hu, Jianying Zhou, Xiaoyan Lin, Lifeng Wang, Yanjun Xu, Hanying Li. Camrelizumab plus apatinib in extensive-stage small-cell lung cancer (PASSION): A multicenter, two-stage, phase 2 trial [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr CT083.