Abstract 1267P
Background
In the open-label, multi-center, phase Ib/II study, promising anti-tumor activity was seen with PD-1 antagonist camrelizumab (SHR-1210) plus angiogenesis inhibitor apatinib in patients (pts) with advanced non-squamous NSCLC. Here, we reported preliminary efficacy and safety results in squamous NSCLC from this study.
Methods
In dose-expansion phase II, pts were assigned to four cohorts according to tumor histology, EGFR/ALK status and therapeutic setting, and received apatinib at the recommended dose of 250 mg orally once daily plus camrelizumab 200 mg every two weeks until disease progression or intolerable toxicity. This dose was chosen on the basis of results from the dose-escalation phase Ib study. In cohort 3, pts with non-central squamous NSCLC who had failed from platinum-based chemotherapy were enrolled. Primary endpoint was objective response rate (ORR) per RECIST version 1.1. Archived or fresh tumor tissues were collected for testing PD-L1 expression before the treatment. Specimens would be considered PD-L1 positive if tumor proportion score ≥1%.
Results
Between October 10, 2018 and March 5, 2019, 25 pts with advanced squamous NSCLC were enrolled. At the data cutoff of December 15, 2019, the median follow-up was 10.1 months (range, 1.6-13.1). Among all 25 pts, the ORR was 32% (8/25, 95% CI, 14.9-53.5%) and disease control rate (DCR) was 84% (21/25, 95% CI, 63.9-95.5%). Median progression-free survival (mPFS) was 6.0 months (95% CI, 3.6-8.3) and median overall survival was 12.8 months (95% CI, 6.4-NR). Furthermore, patients with PD-L1-positive tumors (n=12) had a higher ORR (41.7% vs 20%, p=0.29) and longer mPFS (7.3m vs 5.5m, p=0.41) than those with PD-L1-negative tumors (n=10). The most common treatment-related adverse events of grade 3 or higher were hypertension (11 [44%]) and palmar-plantar erythrodysesthesia syndrome (4 [16%]).
Conclusions
Similarly, camrelizumab plus apatinib also demonstrated promising anti-tumor activity with acceptable safety in pts with advanced squamous NSCLC in terms of ORR, DCR and PFS, especially in those with PD-L1 positive tumors. Prospective study is needed to validate the clinical outcome.
Clinical trial identification
NCT03083041.
Editorial acknowledgement
Legal entity responsible for the study
Jiangsu Hengrui Medicine Co., Ltd.
Funding
Jiangsu Hengrui Medicine Co., Ltd.
Disclosure
S. Ren: Honoraria (institution), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (institution), Advisory/Consultancy: Roche; Honoraria (institution): Hengrui; Honoraria (institution): Jushi; Honoraria (institution): Innovent . R. Guo: Research grant/Funding (self): Qilu. Q. Wang: Full/Part-time employment: Jiangsu Hengrui Medicine Co., Ltd. C. Zhou: Honoraria (institution): Roche; Honoraria (institution): Eli Lily; Honoraria (institution): Boehringer Ingelheim; Honoraria (institution): Merck; Honoraria (institution): Hengrui; Honoraria (institution): Qilu. All other authors have declared no conflicts of interest.