135P - Efficacy and safety of tislelizumab combined with bronchial arterial infusion (BAI) chemotherapy in potentially resectable stage IIIB non-small cell lung cancer(NSCLC): A prospective, single-arm phase II clinical study

Background

Several clinical trials proved neoadjuvant chemoimmunotherapy was considered reliable for stage III non-small-cell lung cancer (NSCLC). Our previous study demonstrated bronchial arterial infusion (BAI) had better efficacy of local control in advanced NSCLC, comparing with chemotherapy. The aim of the study is to confirm efficacy and safety of tislelizumab combined with BAI in stage IIIB NSCLC.

Methods

This single-arm, phase 2 clinical trial enrolled stage IIIB (T3-4N2M0) NSCLC with no EGFR/ALK alterations. All enrolled Pts were considered potentially suitable for complete (R0) resection. Pts received tislelizumab (200mg Q3W, iv) for 3 cycles and BAI Q3W for 2 cycles (docetaxel (75mg/m²) and carboplatin (AUC 5)), followed by surgery within 35 days. Following 2 cycles chemotherapy and tislelizumab maintenance were up to 2 cycles and 1 year duration respectively . The primary endpoint was R0 resection rate, with secondary endpoints including event-free survival (EFS), downstaging rate, objective response rate (ORR), surgery rate, overall survival, major pathological response (MPR), pathological complete response (pCR), and treatment related adverse events (TRAEs).

Results

From January 2023 to September 2024, 24 Pts were enrolled. Median age was 64. 18 Pts were diagnosed with squamous cell lung cancer, and 6 Pts had adenocarcinoma. 20 Pts completed neoadjuvant chemoimmunotherapy and tumor assessment. ORR was 100%, with a complete response (CR) of 25% (5/20) and a partial response (PR) of 75% (15/20). Downstaging rate was 95%, and 18 Pts were suitable for surgical resection (90%). 13 Pts underwent surgical resection including 8 lobectomies, 3 bilobectomies, and 2 pneumonectomies. R0 resection rate was 100%. MPR rate was 84.6% (11/13), and pCR rate was 53.8% (7/13). Median follow-up was 247 days. One-year EFS rate is 80.8%. 15 patients (75%, 15/20) experienced TRAEs. The most common TRAEs were anorexia, myelosuppression, pruritus, and fever. Grade 3 TRAEs occurred in 30% of pts.

Conclusions

Tislelizumab combined with BAI chemotherapy is well tolerated and shows encouraging efficacy compared to retrospective controls.

Clinical trial identification

ChiCTR2300068722.

Legal entity responsible for the study

Shanghai Pulmonary Hospital.

Funding

BeiGene. Ltd.

Disclosure

The authors has declared no conflicts of interest.