Final Analysis of the Neotorch Study: Perioperative Toripalimab in Combination with Chemotherapy for Patients with Stage Ⅱ/Ⅲ Resectable Non-Small Cell Lung Cancer.
Abstract
Background
Interim analysis of the Neotorch study demonstrated significant benefit in event-free survival (EFS) and major pathological response (MPR) rate for perioperative toripalimab plus chemotherapy in patients with resectable Stage Ⅲ non-small cell lung cancer (NSCLC). Here, we report the final analysis results of the overall Stage Ⅱ and Ⅲ patients from this study. PATIENTS AND
Methods
Eligible patients with treatment-naïve resectable Stage II, or Stage IIIA, IIIB (N2) NSCLC, were randomized to receive toripalimab or placebo plus chemotherapy as neoadjuvant treatment (3 cycles), adjuvant treatment (1 cycle), and toripalimab or placebo monotherapy as maintenance treatment (up to 13 cycles). The primary endpoints of this study were EFS assessed by investigators and MPR evaluated by blinded independent pathologic review (BIPR) in Stage Ⅲ patients, as well as the overall Stage Ⅱ and Ⅲ patients.
Results
A total of 501 patients in China were randomized (toripalimab arm: N=250, placebo arm: N=251). The baseline characteristics were generally balanced between the 2 arms. At the final analysis (median follow-up of 48.2 months), the investigator-assessed EFS was significantly improved in the toripalimab arm with stratified hazard ratio (HR) of 0.52 (95% confidence interval [CI]: 0.39, 0.68; stratified P <0.0001), and the median EFS in the toripalimab arm was not reached, while 20.2 months in the placebo arm. The inter-arm difference of MPR rate was statistically significant and clinically meaningful (47% vs 9%, P<0.0001). The OS prolongation was also statistically significant in the toripalimab arm (HR 0.66; 95% CI: 0.49, 0.89, P=0.0072), with median survival not reached in either arm. The safety profile was consistent with the interim analysis, with no new safety signals identified.
Conclusions
Perioperative toripalimab plus chemotherapy demonstrated durable and significant benefits on EFS, MPR, and OS in resectable Stage Ⅱ and Ⅲ NSCLC patients, with a manageable safety profile.