Resectable NSCLC with neoadjuvant chemotherapy(CT) has favourable outcomes. However, with few neoadjuvant immunotherapy trials, detailed information on patients(pts) with resectable stage IIIA and IIIB(T3N2) NSCLC is available. Camrelizumab(Cam), a PD-1 antibody, has shown a survival benefit in patients with advanced NSCLC. However, the antitumor activity and safety of Cam plus CT in the neoadjuvant setting is unknown. Here, we report the final analysis from this multi-center, open-label, randomized controlled phase II trial.
Stage IIIA or IIIB(T3N2) resectable NSCLC were randomized (1:1) to receive Cam, albumin-bound paclitaxel (ab-Pac) and platinum, or ab-Pac plus platinum of a 21-day cycle for 3 cycles(n=47 each). Definitive surgery was to be performed within 4∼6 weeks of treatment. The primary endpoint was pCR. Secondary endpoints included MPR, ORR, DFS by RECIST 1.1, and safety.
From 3/2020 to 9/2022, 94 pts were enrolled and randomly assigned (n=47 each), and 88 pts received neoadjuvant treatment (43 in Cam+CT and 45 in CT). The patient characteristics of both arms were well balanced in the full analysis(FAS). In Cam+CT, 42 pts completed neoadjuvant therapy and efficacy evaluation, among of which 40 had underwent surgery, and in CT, 45 pts completed neoadjuvant therapy and efficacy evaluation, of which 42 underwent surgery. Neoadjuvant Cam+CT significantly increased the pCR rate compared to chemo in the FAS (32.56% vs 8.89%, P =0.0079). Cam+CT also improved MPR rates vs chemo in the FAS (15.56% vs 65.12%), as well as ORR (53.33% vs 72.09%), and 1-year DFS achieved 93.243% and 81.377% respectively. Adverse events (AEs) of the two arms were similar, except reactive cutaneous capillary endothelial proliferation (44.19%; grade 1-2) in the Cam+CT arm. No AEs beyond expectation or of grade 3-5 were reported.
This updated analysis confirms the superiority of the chemo-immuno combination in patients with resectable stage IIIA or IIIB(T3N2) NSCLC in terms of pCR, with a moderate increase in grade 3-5 toxicity. Thus, this treatment should become the standard of care in these patients.
Clinical trial identification
Legal entity responsible for the study
Jiangsu Hengrui Pharmaceutical Co., Ltd.
All authors have declared no conflicts of interest.