Toripalimab Regimen Improves EFS, MPR Rate in Stage II/III NSCLC Trial

Combining toripalimab-tpzi (Loqtorzi) with platinum-based chemotherapy improved event-free survival (EFS) and major pathological responses (MPRs) among patients with resectable stage II or III non–small cell lung cancer (NSCLC), according to a press release on final analysis findings from the phase 3 NEOTROCH trial (NCT04158440) from the developer, Shanghai Junshi Biosciences.¹

Data revealed that toripalimab-based treatment reached the pre-defined efficacy boundary for EFS and MPR rate in the stage II/III cohort as well as MPR rate in the stage III group. Based on these findings, the developers intend to submit a supplemental new drug application (sNDA) to regulatory authorities in the future, which may expand the approval status of perioperative toripalimab plus chemotherapy from stage III populations alone to patients with resectable stage II or III NSCLC.

According to the press release, China’s National Medical Products Administration previously approved perioperative toripalimab plus platinum-based chemotherapy for patients with resectable stage IIIA or IIIB NSCLC based on interim analysis findings from the NEOTORCH trial. This decision marked the first approval of perioperative treatment for lung cancer in China and the second approval across the world.

Investigators previously shared interim analysis findings from the NEOTORCH study at an American Society of Clinical Oncology (ASCO) virtual plenary session in April 2023.² After a median follow-up of 18.25 months, the median EFS was not evaluable (NE; 95% CI, 24.4-NE) with toripalimab plus chemotherapy vs 15.1 months (95% CI, 10.6-21.9) with placebo plus chemotherapy (HR, 0.40; 95% CI, 0.277-0.565; P <.0001). The estimated EFS rates in each respective arm were 84.4% vs 57.0% at 1 year and 64.7% vs 38.7% at 2 years.

Among patients with a PD-L1 expression status of at least 1% (n = 265), data showed that the median EFS was NE in the toripalimab arm and 13.3 months in the placebo arm (HR, 0.31; 95% CI, 0.197-0.481). Regarding those with a PD-L1 expression status of less than 1% (n = 139), the median EFS was NE and 15.3 months in each treatment arm (HR, 0.59; 95% CI, 0.327-1.034).

No new safety signals were reported at the time of the interim analysis. Grade 3 or higher treatment-emergent adverse effects (TEAEs) occurred in 63.4% of the toripalimab arm and 54.0% of the placebo arm. The most common high-grade TEAEs included neutropenia, leukopenia, pneumonia, anemia, and thrombocytopenia.

Investigators of the double-blind NEOTORCH study assessed the safety and efficacy of toripalimab or placebo plus chemotherapy for the perioperative treatment of 501 patients with resectable stage II or III NSCLC. Patients were assigned to receive toripalimab at 240 mg or matched placebo in combination with platinum-based doublet chemotherapy.³

The trial’s primary end points included the MPR rate per blinded independent review in the stage III population, EFS in the stage III population per investigator assessment, MPR rate in the stage II/III population, and EFS in the stage II/III population. Secondary end points included the pathological complete response rate, disease-free survival, and overall survival.

Patients 18 to 70 years old with histologically confirmed resectable stage II, IIIA, or IIIB NSCLC and measurable lesions per RECIST v1.1 criteria were eligible for enrollment on the trial. Other eligibility criteria included having an ECOG performance status of 0 or 1 and adequate organ function.

Those with the presence of locally advanced, unresectable, or metastatic disease; known EGFR mutations or ALK translocations; prior systemic antitumor therapy for early NSCLC; or active tuberculosis were ineligible for enrollment on the trial.

References

1. Junshi Biosciences announces primary endpoints met in final analysis of phase 3 study for perioperative toripalimab plus chemotherapy for resectable stage II-III NSCLC. News release. Shanghai Junshi Biosciences Co., Ltd. May 26, 2026. Accessed May 27, 2026. https://tinyurl.com/4ua92sbz
2. 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. J Clin Oncol. 2023;41(suppl 36; abstr 425126). doi:10.1200/JCO.2023.41.36_suppl.425126
3. Phase III study of toripalimab versus placebo plus chemotherapy in resectable NSCLC. ClinicalTrials.gov. Updated July 9, 2024. Accessed May 27, 2026. https://tinyurl.com/5fvp5xz2