Abstract 143P
Background
Immunotherapy and BACE are important therapy for NSCLC. This trial is designed to determine the efficacy and safety of immunotherapy with tislelizumab in addition to BACE in stage III-IV NSCLC patients (pts) who failed, refused or ineligible to receive standard treatments.
Methods
This trial enrolled stage III-IV pts without EGFR, ALK or ROS1 aberrations who have failed, refused, or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, chemotherapy). Pts were treated with BACE and tislelizumab as induction therapy during which BACE was performed on the first day and tislelizumab was given 3-5 days later, then tislelizumab was administered at 200mg Q3W as maintenance therapy. Primary endpoint was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety, etc. Herein, the treatment response at 6 weeks is reported.
Results
30 pts were enrolled with 24 (80%) males pts and a median age of 65.1y; 21 (70%) squamous, 9 (30%) adenocarcinomas; 4 (13%) stage IIIA, 11 (37%) stage IIIB, 15 (50%) stage IV; 8 (27%) with ECOG score 0, 17 (57%) with score 1, and 5(17%) with score 2. Among the 30 pts, 5 (17%) pts had bronchial stenosis, 2 (7%) had superior vena cava syndrome, 8 (27%) had pneumonia, 4 (13%) had pulmonary heart disease, and 4 (13%) had hemoptysis. The ORR and DCR were 66.7% and 83.3% respectively per RECIST1.1, 2 pts (6.7%) achieved complete response (CR), 18 pts (60.0%) and 5 pts (16.7%) got partial response (PR) and stable disease (SD). The main TEAEs related to BACE mainly include nausea (20.0%, 6/30), fever (16.7%, 5/30), hemoglobin decrease (6.7%, 2/30), leukopenia (10.0%, 3/30) and thrombocytopenia (6.7%, 2/30). TEAEs related to tislelizumab mainly included fatigue (6.7%, 2/30)，rash (10.0%, 3/30) and cough (10.0%, 3/30). Grade≥3 AEs were not observed.
Conclusions
Tislelizumab combined with BACE for advanced NSCLC pts appears to be safe and feasible, and the comorbidities of patients can be alleviated after treatment. Compared with previous studies on BACE, the addition of immunotherapy may improve the ORR and DCR.
Clinical trial identification
NCT05286957.
Legal entity responsible for the study
Hennan Medical Information Society.
Funding
BeiGene.
Disclosure
All authors have declared no conflicts of interest.