2023 World Conference on Lung Cancer (Posters)-P2.01. Efficiency and Survival Data of Neoadjuvant PD-1 Inhibitor Combined With Chemotherapy in Potentially Resectable IIIA or IIIB NSCLC

P2.01. Efficiency and Survival Data of Neoadjuvant PD-1 Inhibitor Combined With Chemotherapy in Potentially Resectable IIIA or IIIB NSCLC - PDF(Slides)

Back to course

Pdf Summary

A single-arm, phase 2 clinical trial evaluated the efficacy and safety of neoadjuvant PD-1 inhibitor (sintilimab) combined with chemotherapy (nab-paclitaxel and carboplatin) in potentially resectable stage IIIA/IIIB non-small cell lung cancer (NSCLC). The study included treatment-naive patients who were deemed unsuitable for R0 resection at initial diagnosis. Patients received neoadjuvant chemoimmunotherapy for two to three cycles before undergoing systematic nodal dissection. The primary endpoint was disease-free survival (DFS) at 24 months, and secondary endpoints included objective response rate (ORR), pathological complete response (pCR) rate, overall survival (OS), downstaging rate, and adverse events (AEs). CD8 expression was also evaluated as a potential biomarker.<br /><br />A total of 30 patients were enrolled, with 20 undergoing surgery. The ORR and disease control rate (DCR) were 67.7% and 96.7%, respectively. The MPR rate was 65%, and the pCR rate was 40%. R0 resection was achieved in all surgical cases. At a median follow-up of 35.7 months, the 2-year DFS rate was 75%. Factors associated with significantly increased 2-year DFS included MPR, surgery for patients meeting surgical criteria, immuno-adjuvant therapy, and high expression of CD8.<br /><br />Three patients (10%) experienced grade 3 or higher immune-related AEs. The study concluded that neoadjuvant immunotherapy for potentially resectable stage IIIA/IIIB NSCLC improved pathological response rate and 2-year DFS compared to chemoradiotherapy plus consolidation immunotherapy. Overexpression of CD8 may be a potential biomarker for predicting DFS. These findings suggest a potential shift in the treatment approach for potentially resectable stage IIIA/IIIB NSCLC in the future.

Asset Subtitle

Kewei Ma

Meta Tag

Speaker Kewei Ma

Topic Local-Regional NSCLC: Novel Therapies & Trials

Keywords

neoadjuvant PD-1 inhibitor

sintilimab

chemotherapy

non-small cell lung cancer

disease-free survival

pathological complete response rate

CD8 expression

biomarker

immuno-adjuvant therapy

treatment approach