Abstract 955P
Background
NeoTAP01 study is a single-arm, phase II study investigating the feasibility of neoadjuvant PD-1 inhibitor toripalimab with chemotherapy in patients with stage III non-small-cell lung cancer (NSCLC). The preliminary results of this trial have been presented in 2021 ASCO abstract 8541, demonstrating a major pathological response(MPR) rate of 66.7% and a pathological complete response(pCR) rate of 50% in the per-protocol population. Here we report the two-year event-free survival (EFS) rate of the study.
Methods
The study enrolled treatment-naïve patients with stage IIIA or T3-4N2 IIIB NSCLCs. Surgical resection was performed 4-5 weeks after three cycles of neoadjuvant PD-1 inhibitor toripalimab (240mg), carboplatin (area under the curve 5), and pemetrexed (500 mg/m 2 for adenocarcinoma) or nab-paclitaxel (260 mg/m 2 for other subtypes) on day 1 of each 21-day cycle. The primary endpoint was the MPR. pCR rate, EFS and safety were set as secondary endpoints.
Results
On April 15, 2022, the median follow-up duration was 16.4 (IQR: 12.8-20.0) months in the intention-to-treat population. 30 of the 33 (90.9%) enrolled patients underwent resection, and 27 (81.8%) of them received adjuvant treatment following the operation. 22 patients (66.7%) received one-year adjuvant toripalimab monotherapy, and 2 patients discontinued adjuvant immunotherapy after 3 months due to grade 3 rash and hypophysitis. All patients survived except one (3.0%) who had disease progression when receiving preoperative treatment died in this analysis. 5 patients (15.2%) had disease relapse and only one of them had an intrathoracic recurrence. The median EFS was not reached in the intention-to-treat population, with a 12-month and 24-month EFS rates of 87.8% and 67.9%, respectively. Patients who achieved MPR showed significantly longer EFS as compared with those without (median EFS: not reached vs. 16.6 months, log-rank P=0.02).
Conclusions
Toripalimab plus chemotherapy as a neoadjuvant treatment showed a promising pathological response for stage III NSCLCs. Adjuvant toripalimab monotherapy was tolerable in most patients. MPR may be used as a surrogate endpoint for long-term survival as patients who achieved MPR had better EFS.
Clinical trial identification
NCT04304248, first Posted March 11, 2020.
Editorial acknowledgement
Legal entity responsible for the study
Sun Yat-sen University Cancer Center.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.