2022 World Conference on Lung Cancer (ePosters)-EP05.02-014. Neoadjuvant Toripalimab Combination in Patients with Stage IIB-IIIB NSCLC: A Single-Arm, Phase 2 Trial (Renaissance Study)

EP05.02-014. Neoadjuvant Toripalimab Combination in Patients with Stage IIB-IIIB NSCLC: A Single-Arm, Phase 2 Trial (Renaissance Study)

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A study was conducted to investigate the efficacy and safety of neoadjuvant toripalimab, the first PD-1 inhibitor from China, in combination with double platinum-based chemotherapy for stage IIB-IIIB non-small cell lung cancer (NSCLC). The study enrolled patients with wildtype EGFR/ALK NSCLC and ECOG PS 0-1 status. The primary endpoints were major pathological response (MPR) and complete pathological response (pCR), while secondary endpoints included objective response rate (ORR), R0 resection rate, and safety. A total of 53 patients were enrolled, and 49 patients completed the treatment schedule. The median interval between neoadjuvant treatment and surgery was 67 days. Results showed that all 39 patients who underwent resection achieved R0 resection. MPR was achieved in 25 patients, including pCR in 20 patients. Nodal downstaging was observed in 29 out of 31 patients who underwent surgery with cN2/N1 at baseline. The ORR was 85.7% in the evaluated patients. Adverse events were reported in a majority of patients, with grade 1-2 TRAEs in 93.9% and grade 3-4 TRAEs in 30.6%. Five patients experienced immune-related adverse events (irAEs) and received glucocorticoid therapy. The study observed a potential correlation between irAEs and the efficacy of neoadjuvant toripalimab combination. Overall, the study suggests that neoadjuvant toripalimab plus platinum-based doublet is a promising, tolerable, and effective treatment for patients with stage IIB-IIIB NSCLC.

Asset Subtitle

Shi Yan

Meta Tag

Speaker Shi Yan

Topic Locally Advanced Non-small Cell Lung Cancer - Neoadjuvant and Adjuvant Therapy

Keywords

neoadjuvant toripalimab

PD-1 inhibitor

China

platinum-based chemotherapy

non-small cell lung cancer

NSCLC

wildtype EGFR/ALK

ECOG PS 0-1

major pathological response

complete pathological response