Dataset Information

Efficacy and safety of camrelizumab plus apatinib in previously treated patients with advanced non-small cell lung cancer harboring EGFR or ALK genetic aberration.

ABSTRACT:

Background

Camrelizumab plus apatinib shows encouraging antitumor activity and acceptable toxicity in chemotherapy-pretreated patients with advanced non-small cell lung cancer (NSCLC); however, clinical benefits from this combination regimen in NSCLC patients with EGFR mutations or ALK rearrangements (EGFR+/ALK+) have not been reported. We assessed the efficacy and safety of this combined regimen in pretreated patients with advanced NSCLC and defined EGFR/ALK status (EGFR+/ALK+) in a phase 1b/2 trial.

Methods

Previously treated patients with advanced EGFR+/ALK+ NSCLC were enrolled and given camrelizumab 200 mg intravenously every 2 weeks plus apatinib at the recommended dose of 250 mg orally once daily. Patients harboring sensitive EGFR mutations or ALK fusion genes had received at least one EGFR/ALK TKI and a platinum-based chemotherapy regimen before the enrollment. The primary endpoint was objective response rate (ORR).

Results

All 43 enrolled patients comprised the efficacy and safety analysis population. The confirmed ORR was 18.6% (95% CI: 8.4-33.4%) and the clinical benefit response rate was 27.9% (95% CI: 15.3-43.7%). Median progression-free survival (PFS) was 2.8 months (95% CI: 1.9-5.5 months) and median overall survival was not reached (95% CI: 7.3 months-not reached), with a median follow-up period of 15.7 months (range, 0.5-24.4 months). The most common grade ≥3 treatment-related adverse events (TRAEs) were hypertension (16.3%), proteinuria (11.6%) and palmar-plantar erythrodysaesthesia syndrome (9.3%). No unexpected adverse events were recorded.

Conclusions

Camrelizumab plus apatinib showed moderate antitumor activity and acceptable safety profile in previously treated patients with advanced NSCLC and EGFR or ALK genetic aberrations, which warranted further validation.

Trial registration

ClinicalTrials.gov identifier: NCT03083041. Registered March 17, 2017.

SUBMITTER: Gao G

PROVIDER: S-EPMC9271438 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of camrelizumab plus apatinib in previously treated patients with advanced non-small cell lung cancer harboring <i>EGFR</i> or <i>ALK</i> genetic aberration.

Gao Guanghui G Ni Jian J Wang Yina Y Ren Shengxiang S Liu Zhihua Z Chen Gongyan G Gu Kangsheng K Zang Aimin A Zhao Jun J Guo Renhua R He Jianxing J Lin Xiaoyan X Pan Yueyin Y Ma Zhiyong Z Wang Zhehai Z Fan Min M Liu Yunpeng Y Cang Shundong S Yang Xinfeng X Li Weixia W Wang Quanren Q Zhou Caicun C

Translational lung cancer research 20220601 6

<h4>Background</h4>Camrelizumab plus apatinib shows encouraging antitumor activity and acceptable toxicity in chemotherapy-pretreated patients with advanced non-small cell lung cancer (NSCLC); however, clinical benefits from this combination regimen in NSCLC patients with EGFR mutations or ALK rearrangements (EGFR+/ALK+) have not been reported. We assessed the efficacy and safety of this combined regimen in pretreated patients with advanced NSCLC and defined EGFR/ALK status (EGFR+/ALK+) in a pha ...[more]

PMID: 35832447

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