Perioperative toripalimab plus chemotherapy improves event-free survival (EFS) over chemotherapy alone in patients with stage III non-small cell lung cancer (NSCLC), according to results of the phase 3 Neotorch study.
The improvement in EFS was seen across PD-L1 subgroups, said study author Shun Lu, PhD, of the Shanghai Chest Hospital of Shanghai Jiao Tong University in China. Dr Lu presented results from this study at the ASCO Annual Meeting 2023.
The Neotorch study (ClinicalTrials.gov Identifier: NCT04158440) included 404 patients with newly diagnosed, resectable stage III NSCLC. They were randomly assigned to receive platinum-based chemotherapy plus either toripalimab (240 mg; n=202 patients) or placebo (n=202) every 3 weeks for 3 cycles before surgery and 1 cycle after surgery. Maintenance consisted of toripalimab (240 mg) or placebo every 3 weeks for up to 13 cycles.
At baseline, the study arms were well balanced for age, sex, smoking history, performance status, tumor histology and stage, and PD-L1 expression.
The pathologic complete response rate was 24.8% in the toripalimab arm and 1% in the placebo arm. The major pathologic response rate was 48.5% and 8.4%, respectively.
The median EFS by investigator assessment was not reached in the toripalimab arm and was 15.1 months in the placebo arm (hazard ratio [HR], 0.40; 95% CI, 0.277-0.565; P <.0001).
The 12-month EFS rate was 84.4% in the toripalimab arm and 57.0% in the placebo arm. The 24-month EFS rate was 64.7% and 38.7%, respectively.
A subgroup analysis showed similar EFS results regardless of PD-L1 expression levels. On the other hand, there was a significant improvement in EFS with toripalimab for patients with squamous NSCLC (P <.0001), but the improvement in EFS did not reach significance for patients with non-squamous NSCLC (P =.08).
Overall survival (OS) data were not mature at a median follow-up of 18.25 months. However, the median OS was not reached in the toripalimab arm and was 30.4 months in the placebo arm (HR, 0.62; 95% CI, 0.38-0.999; P =.0502).
The 12-month OS rate was 94.4% in the toripalimab arm and 89.6% in the placebo arm. The 24-month OS rate was 81.2% and 74.3%, respectively.
Dr Lu said toripalimab plus chemotherapy was well tolerated, and no new safety signals were observed. Treatment-emergent adverse events (AEs) occurred in all but 1 of the patients in the toripalimab arm and all but 3 of the patients in the placebo arm.
Grade 3 or higher AEs occurred in 63.4% of patients in the toripalimab arm and 54.0% of those in the placebo arm. AEs led to treatment discontinuation in 9.4% of patients receiving toripalimab and 7.4% of those receiving placebo. There was 1 fatal AE considered related to toripalimab.
Postoperative surgery-related AEs were similar between the arms overall. However, these AEs led to treatment interruption in 6.6% of patients in the toripalimab arm and 1.4% of those in the placebo arm.
“The results from the Neotorch study, as well as other studies, indicate that perioperative immunotherapy plus chemotherapy should be a standard of care for stage III non-small cell lung cancer patients,” Dr Lu concluded.
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 2023. June 2-6, 2023. Abstract 8501.