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Ref Type Journal Article
PMID (33323401)
Authors Zhou C, Wang Y, Zhao J, Chen G, Liu Z, Gu K, Huang M, He J, Chen J, Ma Z, Feng J, Shi J, Yu X, Cheng Y, Yao Y, Chen Y, Guo R, Lin X, Wang ZH, Gao G, Wang QR, Li W, Yang X, Wu L, Zhang J, Ren S
Title Efficacy and biomarker analysis of camrelizumab in combination with apatinib in patients with advanced non-squamous NSCLC previously treated with chemotherapy.
Journal Clinical cancer research : an official journal of the American Association for Cancer Research
Vol
Issue
Date 2020 Dec 15
URL
Abstract Text Our preclinical work suggests that appropriate angiogenesis inhibition could potentiate PD-1/PD-L1 blockade via alleviating hypoxia, increasing infiltration of CD8+ T cells and reducing recruitment of tumor-associated macrophages. We hereby conducted a clinical trial to evaluate this combination in pretreated patients with advanced NSCLC.The study included phase Ib apatinib dose-escalation and phase II expansion cohorts. Patients received apatinib at doses of 250-500 mg orally once daily, in combination with camrelizumab 200 mg intravenously every 2 weeks.From March, 2017 to October, 2018, 105 chemotherapy-pretreated patients with non-squamous NSCLC were enrolled and received apatinib 250 mg (recommended phase 2 dose) and camrelizumab. Among them, one (1.0%) complete response, 28 (26.7%) partial responses, and 48 (45.7%) stable diseases were observed. In the efficacy-evaluable population (n = 94), objective response rate (ORR) was 30.9% (95% CI, 21.7-41.2). The median progression-free survival was 5.7 months (95% CI, 4.5-8.8) and overall survival was 15.5 months (95% CI, 10.9-24.5). Efficacy of combination therapy was evident across all PD-L1 and tumor mutation burden subgroups, and appeared to be improved in patients with STK11/KEAP1 mutation (mutant vs. wild-type, ORR: 42.9% vs 28.1%; 1-year survival rate: 85.1% vs. 53.1%). No unexpected adverse events were observed.Combined apatinib and camrelizumab showed encouraging antitumor activity and acceptable toxicity in chemotherapy-pretreated patients with advanced non-squamous NSCLC. Patients with STK11/KEAP1 mutation might derive more benefits from this combination. We will validate these results in an ongoing phase III trial (NCT04203485).

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
STK11 mutant lung non-squamous non-small cell carcinoma predicted - sensitive Camrelizumab + Rivoceranib Phase Ib/II Emerging In a Phase Ib/II trial, non-squamous NSCLC patients harboring STK11 and/or KEAP1 mutations (n=14) demonstrated an improved 12-month survival rate (85.1% vs 53.1%; p=0.01), and a trend towards improved objective response rate (42.9% vs 28.1%; p=0.33), disease control rate (92.9% vs 65.6%, p=0.053), and median progression-free survival (9.4 vs 5.3 months; p=0.64) compared to wild-type STK11/KEAP1 patients (n=32) treated with Camrelizumab (SHR-1210) plus Rivoceranib (apatinib) (PMID: 33323401; NCT03083041). 33323401
Unknown unknown lung non-squamous non-small cell carcinoma not applicable Camrelizumab + Rivoceranib Phase Ib/II Actionable In a Phase Ib/II trial, Camrelizumab (SHR-1210) plus Rivoceranib (apatinib) demonstrated safety and resulted in a 30.9% (29/94; one complete, 28 partial responses) objective response rate, 81.9% (77/94) disease control rate, 52.1% (49/94; disease control lasting 24 weeks or more) clinical benefit response rate, median progression-free survival of 5.7 months, and median overall survival of 15.5 months in evaluable patients with non-squamous NSCLC who received prior chemotherapy (PMID: 33323401; NCT03083041). 33323401