Adding perioperative toripalimab to chemotherapy improves event-free survival (EFS) in patients with resectable, stage III non-small cell lung cancer (NSCLC), according to results from the Neotorch study.
The study showed that patients who received toripalimab with platinum-based chemotherapy had a 60% lower risk of recurrence, progression, or death than patients who received chemotherapy alone.
These results were presented at an ASCO Plenary session by Shun Lu, PhD, of Shanghai Chest Hospital and Shanghai Jiao Tong University in China.
Neotorch is a phase 3 study (ClinicalTrials.gov Identifier: NCT04158440) that enrolled 404 patients. Nearly all patients had stage III NSCLC, but 2 patients had stage IV disease. The median age at baseline was 62 (range, 29-70) years. Most patients were men (91.6%) and had squamous histology (77.7%).
The patients were randomly assigned to receive 240 mg of toripalimab (n=202) or placebo (n=202), each combined with platinum-based chemotherapy every 3 weeks for 3 cycles before surgery and 1 cycle after surgery. This was followed by toripalimab or placebo monotherapy every 3 weeks for up to 13 cycles.
The median follow-up was 18.3 months. The primary endpoints were EFS per investigator and major pathologic response rate per blinded independent pathologic review (BIPR).
The median EFS was not reached for patients treated with toripalimab and was 15.1 months for patients who received chemotherapy alone (hazard ratio [HR], 0.40; 95% CI, 0.277-0.565; P <.0001).
The 1-year EFS rate was 84.4% in the toripalimab arm and 57.0% in the chemotherapy-alone arm. The 2-year EFS rate was 64.7% and 38.7%, respectively.
Per BIPR, patients in the toripalimab arm had a higher major pathologic response rate than patients in the chemotherapy-alone arm (48.5% and 8.4%, respectively; P <.0001). Patients in the toripalimab arm also had a higher pathologic complete response rate per BIPR (24.8% vs 1.0%; P <.0001).
There was a trend toward improved overall survival (OS) with toripalimab, Dr Lu said. The median OS was not reached with the combination and was 30.4 months with chemotherapy alone (HR, 0.62; 95% CI, 0.381-0.999; P =.0502).
The 1-year OS rate was 94.4% in the toripalimab arm and 89.6% in the chemotherapy-alone arm. The 2-year OS rate was 81.2% and 74.3%, respectively.
The rate of treatment-emergent adverse events (TEAEs) was 99.5% in the toripalimab arm and 98.5% in the chemotherapy-alone arm. The rate of grade 3 or higher TEAEs was 63.4% and 54.0%, respectively. The rate of fatal TEAEs was 3.0% and 2.0%, respectively.
The most common TEAEs in both arms were anemia, neutropenia, leukopenia, cough, increased alanine transaminase and aspartate transaminase, hypoproteinemia, arrhythmia, and alopecia.
Disclosures: This research was supported by Shanghai Junshi Biosciences Co, Ltd. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Lu S, Wu L, Zhang W, et al. Perioperative toripalimab + platinum-doublet chemotherapy vs chemotherapy in resectable stage II/III non-small cell lung cancer (NSCLC): Interim event-free survival (EFS) analysis of the phase III Neotorch study. ASCO Plenary Series. April 2023. Abstract 425126.