Abstract 19P
Background
CTONG 2003 is a multicenter, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of camrelizumab plus chemotherapy, with or without radiotherapy, in patients with treatment-naïve NSCLC and brain metastases (BM). This subgroup analysis aims to evaluate the impact of this regimen in patients stratified by radiotherapy use and the presence of baseline neurological symptoms.
Methods
In the CTONG 2003 trial, treatment-naïve NSCLC patients with BM, negative for EGFR/ALK mutations, were randomized 1:1 to receive camrelizumab or placebo combined with platinum-doublet chemotherapy. Maintenance therapy with camrelizumab or placebo ± pemetrexed was continued for up to 31 cycles. Radiotherapy, if required, was administered within 42 days of the first treatment dose. The co-primary endpoints were intracranial PFS (iPFS) and overall PFS.
Results
Among the 60 randomized patients (32 camrelizumab, 28 placebo), camrelizumab demonstrated superior median iPFS (12.7 months vs. 9.9 months; HR: 0.45, 95% CI: 0.21–0.96) and PFS (9.7 months vs. 6.7 months; HR: 0.57, 95% CI: 0.29–1.11) compared to placebo in the overall population. In patients receiving radiotherapy, the camrelizumab group (n=21) achieved a median iPFS of 19.1 months (95% CI: 7.1-NE) compared to 9.9 months (95% CI: 5.7–15.0) in the placebo group (n=23) (HR: 0.42, 95% CI: 0.17–1.01). The median PFS in the camrelizumab group was 11.2 months (95% CI: 5.7–19.4) versus 6.7 months (95% CI: 4.1–7.5) in the placebo group (HR: 0.42, 95% CI: 0.19–0.94). In patients with neurological symptoms at baseline, the median iPFS was not reached in the camrelizumab group (n=12) (95% CI: 6.5-NE), compared to 8.7 months (95% CI: 1.3–20.5) in the placebo group (n=11) (HR: 0.27, 95% CI: 0.06–1.29). Similarly, the median PFS was 11.1 months (95% CI: 3.2-NE) with camrelizumab versus 6.9 months (95% CI: 1.3–8.6) with placebo (HR: 0.15, 95% CI: 0.03–0.75).
Conclusions
The CTONG 2003 trial underscores the efficacy of camrelizumab combined with chemotherapy in treatment-naïve NSCLC patients with BM, particularly in those receiving radiotherapy or presenting with baseline neurological symptoms.
Clinical trial identification
NCT04768075; release date: 2021-02-24.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals, Guangdong Association of Clinical Trials (GACT)/Chinese Thoracic Oncology Group (CTONG).
Disclosure
J. Lv: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals Co., Ltd. All other authors have declared no conflicts of interest.