Journal
JOURNAL OF THORACIC ONCOLOGY
Volume 16, Issue 2, Pages 299-309Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jtho.2020.10.002
Keywords
SCLC; Camrelizumab; Apatinib; PD-1 inhibitor; VEGFR
Categories
Funding
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.
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The study demonstrated potential antitumor activity of camrelizumab plus apatinib in patients with ED-SCLC who had failed platinum-based chemotherapy, including those who were chemotherapy-sensitive and chemotherapy-resistant. Treatment-related adverse events of grade 3 or higher were reported in a significant proportion of patients, leading to treatment discontinuation in some cases. Further clinical studies are warranted to explore the efficacy of this combination therapy in SCLC.
Introduction: Treatment options in the second-line extensive-stage SCLC (ED-SCLC) setting are limited. The PASSION study (ClinicalTrials.gov identifier: NCT03417895) was a phase 2 study of camrelizumab plus apatinib in ED-SCLC after platinum-based chemotherapy. Methods: In stage I of the study, patients were randomized (1:1:1) to receive camrelizumab 200 mg every 2 weeks plus apatinib 375 mg once daily (QD), 5 days on and 2 days off, or 7 days on and 7 days off (six patients each cohort). On the basis of tolerability during the first 28-day cycle and efficacy data at stage I, one cohort was chosen to expand to 45 patients at stage II. The primary end point was objective response rate (ORR). Results: From April 20, 2018 to March 12, 2019, a total of 59 patients were enrolled, with 47 patients in the QD cohort. In the QD cohort, confirmed ORR reached 34.0% (95% confidence interval: 20.9-49.3), the median progression-free survival was 3.6 months, and the median overall survival was 8.4 months. Chemotherapy-sensitive and chemotherapy-resistant patients (defined as patients with disease relapse at >= 90 and <90 d after platinum-based chemotherapy, respectively) had comparable confirmed ORR (37.5% versus 32.3%), median progression-free survival (3.6 versus 2.7 mo), and median overall survival (9.6 versus 8.0 mo). Treatment-related adverse events of grade 3 or higher were reported in 43 of 59 patients (72.9%). Five patients (8.5%) discontinued because of treatment-related adverse events. Conclusions: Camrelizumab plus apatinib exhibited potential antitumor activity in patients with both chemotherapy-sensitive and chemotherapy-resistant ED-SCLC who had failed platinum-based chemotherapy with an acceptable toxicity profile. This phase 2 data warrant further clinical studies of camrelizumab plus apatinib in SCLC. (C) 2020 Published by Elsevier Inc. on behalf of International Association for the Study of Lung Cancer.
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