Abstract 31P
Background
The CAP-BRAIN trial indicated that the combination of camrelizumab, pemetrexed and carboplatin as a first-line therapy was active and well-tolerated in patients with advanced non-squamous NSCLC and brain metastases (BMs). In this report, we presented the final overall survival (OS) results.
Methods
In this multicenter, single-arm, phase II trial (CAP-BRAIN), patients diagnosed with advanced non-squamous NSCLC who presented with asymptomatic BMs (or with controlled symptoms following dehydration therapy) and had not received prior systemic therapy were treated with four cycles of camrelizumab plus pemetrexed and carboplatin. This regimen was administrated intravenously on day 1 of each 21-day cycle. Subsequently, patients received maintenance therapy with camrelizumab and pemetrexed until disease progression, unacceptable toxicity or death. OS, a secondary endpoint, was estimated using the Kaplan-Meier method.
Results
As of September 11, 2024, the median follow-up was 37.4 months (95% CI 32.6–42.8). Of the 45 patients, 29 had died, with the median OS of 18.4 months (95% CI 10.3–29.9). The 2- and 3-year OS rates were estimated to be 39.2% (95% CI 24.4%–54.0%) and 33.4% (95% CI 18.7%–48.0%), respectively. No new safety signals and additional treatment-related deaths were reported. Five (11.1%) of the 45 patients completed the pre-specified 24 months of camrelizumab and remained on maintenance chemotherapy. A total of 25 patients with disease progression received second-line systemic therapy, with the most common regimen being antiangiogenic agents plus chemotherapy (36.0%). Ten patients with disease progression subsequently received brain radiotherapy (BRT), with the median time to BRT of 7.7 months (IQR 5.9–11.1). Among patients with intracranial progression, the median post-intracranial progression survival was 13.6 and 12.5 months in patients with or without BRT, respectively.
Conclusions
The final OS results continued to support the promise of first-line camrelizumab in combination with pemetrexed and carboplatin for the treatment of advanced non-squamous NSCLC patients with BMs.
Clinical trial identification
NCT04211090.
Legal entity responsible for the study
Sun Yat-Sen University Cancer Center.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
J. Lv, F. Cheng, C. Ma: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals Co., Ltd. L. Chen: Financial Interests, Personal, Principal Investigator: Jiangsu Hengrui Pharmaceuticals Co., Ltd. All other authors have declared no conflicts of interest.