Talk Description
Between March 2023 and July 2024, a total of 81 patients were enrolled, of whom 70 met the eligibility criteria and completed two cycles of neoadjuvant toripalimab plus paclitaxel and nedaplatin. All 70 patients were included in the primary efficacy and safety analyses. Subsequently, 64 patients underwent surgery and had pathological specimens available for analysis of pathologic response (pCR/MPR) . Among the 70 enrolled patients, the neoadjuvant therapy yielded an objective response rate (ORR) of 82.7%. This included a complete response (CR) rate of 18.6% and a partial response (PR) rate of 64.2%, while 8.6% of patients had stable disease (SD) and 8.6% experienced progressive disease (PD). Of this cohort, 91.5% of patients proceeded to surgery, and among the 64 surgically treated patients, 29.7% (19/64; 95% CI, 18.9%–42.7%) achieved a pathological complete response (pCR). The major pathological response (MPR) rate was 56.3% (36/64; 95% CI, 43.3%–68.4%). PD-L1 combined positive score (CPS) was evaluable in samples from 66 patients (92.9%), with 62.1% of these patients having a CPS ≥ 1 . For the 64 patients who underwent surgery, we assessed the concordance between pathologic response and several parameters, including radiographic response, PD-L1 CPS, T stage, and N stage. Most patients who achieved a radiographic CR also attained an MPR, whereas only one patient with radiographic PD achieved an MPR . Patients who achieved an objective radiographic response were 7 significantly more likely to attain pCR (P=0.001). Although a higher proportion of patients with CPS ≥ 1 achieved MPR compared to those with CPS < 1, the difference was not statistically significant (P=0.313,). Furthermore, neither T stage nor N stage showed a significant association with pathologic response.
Adverse events (AEs) during neoadjuvant treatment were predominantly Grade 1-2 and manageable. Only 4.3% of patients experienced Grade 3 immune-related pneumonitis, which led to surgical delay. Overall, the treatment regimen was safe and well-tolerated. As of June 16, 2025, the median follow-up duration was 19.1 months (range, 10.9–28.0 months). The 1- and 2-year overall survival (OS) rates were 100% (95% CI, 100–100) and 93% (95% CI, 83.1–100), respectively. The 1- and 2-year event-free survival (EFS) rates were 88.2% (95% CI, 80.8–96.2) and 71.1% (95% CI, 58.1–88.5), respectively. 8 Prognostic analysis stratified by CPS status revealed no significant differences in either OS (P=0.75) or EFS (P=0.79), between the CPS ≥ 1 and CPS < 1 groups.
Presenters
Authors
Authors
Professor Zhenghua Lyu -