Abstract 209P
Background
The primary analyses of NeoTAP01 trial reported previously demonstrated the encouraging effectiveness and safety of perioperative toripalimab plus chemotherapy in resectable stage III non-small cell lung cancer (NSCLC). We now presented the 4-year follow-up outcomes in order to confirmed the stability of its benefits.
Methods
This trial enrolled NSCLC patients with resectable stage IIIA and IIIB to received neoadjuvant toripalimab plus chemotherapy every 3 weeks for a total of 3 cycles before surgery. Adjuvant toripalimab was planned to conduct for 12 cycles after surgery. Patients who received at least 2 cycles of neoadjuvant treatment and definitive surgery were in the per-protocol (PP) population and used for final analysis. In the follow-up duration, long-term outcomes, such as event-free survival (EFS), overall survival (OS), recurrence patterns, adverse effects, and genome mutations were collected.
Results
30 of 33 patients were included in the PP population. On December 1, 2024, the median follow-up duration was 51.6 months (95% confidence interval, 46.7–56.6) in the PP population. 4-year EFS and OS rates were 66.7% (20/30) and 83.3% (25/30), respectively. The presence of pathologic complete response (pCR) trended toward favorable EFS (hazard ratio, 0.09; 95% confidence interval, 0.01–0.76). 90% (27/30) patients received at least 3 cycles of adjuvant treatment, but limited benefit was founded. 20% (6/30) recurrence occurred less than 1 year after surgery. The association between negative immune regulators (STK11 and KEAP1) and adjuvant treatment effectiveness was not observed. For the treatment-related adverse effects (TRAEs), grade 3 pneumonitis happened in 10% (3/30) patients during the adjuvant therapy. No other grade 3–5 TRAEs were further reported.
Conclusions
The 4-year clinical outcomes for perioperative toripalimab plus chemotherapy in resectable stage III NSCLC showed a sustained improvement in long-term EFS and OS. However, the effectiveness and safety of adjuvant treatment for those patients were still unclear, though definitive conclusions are limited by cohort size.
Clinical trial identification
NCT04304248; Release Date: 2020–03-11.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.