1439P - Brain radiotherapy combined with camrelizumab and platinum-based chemotherapy as first-line treatment for advanced NSCLC with brain metastases: A multicenter, open-label, single-arm, phase II study

Background

Preclinical data have shown a synergistic effect of radiotherapy (RT) combined with immunotherapy. However, the effect of combining RT with immunotherapy remains unknown for advanced NSCLC with brain metastases (BMs). This study aimed to assess the preliminary efficacy and safety of brain RT combined with camrelizumab plus platinum-based chemotherapy as first-line treatment in NSCLC patients (pts) with BMs.

Methods

Treatment-naïve pts with NSCLC and BMs were adults who had no known EGFR/ALK/ROS1 alterations and had at least one measurable intracranial and extracranial lesions per RECIST 1.1. Eligible pts received camrelizumab (200 mg) and platinum-based chemotherapy intravenously every 3 weeks for 4-6 cycles after stereotactic radiosurgery or whole-brain RT. Subsequently, pts without disease progression received maintenance treatment with camrelizumab ± pemetrexed every 3 weeks up to 24 months, or until disease progression or intolerance. The primary endpoint was 6-month progression-free survival (PFS) rate.

Results

Between May 6, 2020 and April 25, 2023 (data cutoff), 65 pts were enrolled and treated. The primary endpoint 6-month PFS rate was 70.2% (95% CI 56.3-80.4). With a median follow-up of 11.2 months (95% CI 9.0-17.0), the median PFS was 8.7 months (95% CI 7.5-15.7), and median overall survival was 21 months (95% CI 15.1-NE). Of the 65 pts, 49 (75.4%) pts had a confirmed partial response and 14 (21.5%) had stable disease, with the overall objective response rate (ORR) and disease control rate of 75.4% (95% CI 63.1%-85.2%) and 96.9% (95% CI 89.3%-99.6%). The intracranial ORR was 81.5% (95% CI 70%-90.1%). Adverse events (AEs) of any grade occurred in 64 (98.5%) of the 65 pts, and grade 3 or 4 AEs were observed in 32 (49.2%) pts, with the most common being neutrophil count decreased (14 [21.5%]) and white blood cell count decreased (11 [16.9%]). No treatment-related deaths occurred.

Conclusions

The combination of brain radiotherapy, camrelizumab and platinum-based chemotherapy showed promising efficacy and manageable toxicity for treatment-naïve advanced NSCLC with BMs.

Clinical trial identification

NCT04291092 First posted: March 2, 2020; Last update posted: September 10, 2021.

Editorial acknowledgement

Legal entity responsible for the study

Zhejiang Cancer Hospital.

Funding

Natural ScientificFoundation of China (Grant No. 81972718) and the Natural ScientificFoundation of Zhejiang Province, China (Grant No. LY19H160007).

Disclosure

All authors have declared no conflicts of interest.