Addition of Camrelizumab to Neoadjuvant Chemotherapy Significantly Improved Response Rate Among Patients With Resectable, Stage IIIA-IIIB NSCLC

Results From the Phase 2 TD-FOREKNOW Trial 

Findings from the phase 2 TD-FOREKNOW trial demonstrated that the addition of camrelizumab, a selective immunoglobulin G4-κ monoclonal antibody, to neoadjuvant chemotherapy significantly improved pathologic complete response (pCR) rate compared to chemotherapy alone among patients with resectable stage IIIA to IIIB non-small cell lung cancer (NSCLC) with manageable toxicity. 

As Jie Lei, MD, The Second Affiliated Hospital of Air Force Medical University, Xi’an, China, and coauthors stated, previous findings from “the phase 3 CameL and CameL-Sq studies [demonstrated] camrelizumab combined with chemotherapy showed an improvement in survival vs chemotherapy as first-line treatment for patients with advanced NSCLC,” however “data are lacking to support this combination as a neoadjuvant therapeutic strategy for resectable NSCLC.”

In this trial, 94 patients from 2 Chinese institutions were randomized on a 1-to-1 basis between April 7, 2020 and January 12, 2022 to receive either 200mg neoadjuvant camrelizumab on day 1 of each cycle plus investigators choice of neoadjuvant chemotherapy (nab-paclitaxel, 130 mg/m², and platinum [cisplatin, 75 mg/m²; carboplatin, area under the curve, 5; or nedaplatin, 100 mg/m²]), or neoadjuvant chemotherapy alone, for 3 3-week cycles followed by surgical resection 4 to 6 weeks after neoadjuvant treatment. The primary end point was pCR rate. Secondary end points included major pathologic complete response (MPR) rate, objective response rate (ORR), and safety. 

At a median follow-up of 14.1 months, 88 of 94 enrolled patients were treated with either camrelizumab plus chemotherapy (n = 43) or chemotherapy alone (n = 45). In the camrelizumab arm, the pCR rate was 32.6% vs 8.9% in the chemotherapy arm (odds ratio, 4.95; 95% [confidence interval] CI, 1.35 to 22.37; P = .008). MPR rates were 65.1% in the camrelizumab arm and 15.6% in the chemotherapy arm. Radiographic ORRs were 72.1% and 53.3%, respectively. 

The safety profile was consistent with that of previous studies analyzing camrelizumab plus chemotherapy. Grade ≥3 treatment-related adverse events occurred in 25.6% of patients in the camrelizumab arm and 11.1% of patients in the chemotherapy arm. The most frequent events among patients in both treatment arms included decreased white blood cell count and decreased neutrophil count. There were no treatment-related deaths. 

Dr Lei et al concluded these results suggest “this combination might be a novel neoadjuvant treatment option for this patient population.”

Source: Lei J, Zhao J, Gong L, et al. Neoadjuvant camrelizumab plus platinum-based chemotherapy vs chemotherapy alone for Chinese patients with resectable stage IIIA or IIIB (T3N2) non–small cell lung cancer: The TD-FOREKNOW Randomized Clinical Trial. JAMA Oncol. Published online August 3, 2023. doi:10.1001/jamaoncol.2023.2751