Neotorch (NCT04158440) is a phase 3 trial in China testing perioperative toripalimab, Junshi Biosciences’ anti-PD-1 antibody, with chemotherapy for resectable stage II–III NSCLC. Perioperative toripalimab is approved in China for resectable stage IIIA–IIIB NSCLC only; it is not FDA or EMA approved for lung cancer (in the US, LOQTORZI is approved for nasopharyngeal carcinoma). At ESMO 2026 (LBA64) and in Annals of Oncology, the final analysis showed EFS HR 0.52 and MPR 47.2% vs 9.2% (primary endpoints) and OS HR 0.66 (secondary endpoint).
See the LBA64 Results →Neotorch has four primary endpoints: event-free survival (EFS) by investigator and major pathological response (MPR) by blinded independent pathologic review (BIPR), each in the stage III population and in the full stage II–III population. The interim analysis (data cutoff November 30, 2022) met the stage III EFS endpoint. Junshi Biosciences reported in May 2026 that the final analysis met EFS and MPR in the stage II–III population and MPR in the stage III population. Overall survival, pCR, EFS by independent review, disease-free survival and safety are secondary endpoints. All final-analysis figures below are from the data cutoff of April 18, 2026 (median follow-up 48.2 months) unless labelled otherwise.
LBA64 presentation slides (Shun Lu, ESMO 2026) · Junshi Biosciences release, May 26, 2026 · ClinicalTrials.gov NCT04158440Median investigator-assessed EFS was not reached (95% CI 51.3–not estimable) with toripalimab plus chemotherapy vs 20.2 months (14.3–24.8) with placebo plus chemotherapy: HR 0.52 (95% CI 0.391–0.677), P < 0.0001. EFS rates were 71.5% vs 45.5% at 24 months and 63.1% vs 40.6% at 36 months. EFS by independent review (a secondary endpoint) was consistent: HR 0.53 (0.395–0.701), median not reached vs 22.6 months.
EFS HR 0.52 · NR vs 20.2 moBy blinded independent pathologic review, MPR was 47.2% (95% CI 40.9–53.6) vs 9.2% (5.9–13.4), a difference of 38% (31–45), P < 0.0001. Pathological complete response, a secondary endpoint, was 25.6% (20.3–31.5) vs 1.2% (0.2–3.5), a difference of 24% (19–30).
MPR 47.2% vs 9.2% · pCR 25.6% vs 1.2%There were 73 deaths (29.2%) with toripalimab vs 99 (39.4%) with placebo, at 34.3% maturity. Median OS was not reached in either arm: HR 0.66 (95% CI 0.49–0.89; abstract 0.486–0.894), P = 0.0072. OS rates were 84% vs 78% at 24 months and 78% vs 67% at 36 months. The LBA64 abstract and the Annals of Oncology paper describe the OS improvement as statistically significant.
OS HR 0.66 · P = 0.0072 · secondary endpoint, 34.3% maturityEFS hazard ratios were 0.41 (0.264–0.631) for PD-L1 1–49% (164 patients) and 0.47 (0.262–0.812) for PD-L1 ≥50% (157 patients). For PD-L1 <1% (129 patients), median EFS was 51.3 vs 20.2 months and the HR was 0.72 (0.436–1.191), with a confidence interval that crosses 1. These subgroups were not powered for separate conclusions.
LBA64 presentation slides (Shun Lu, ESMO 2026)The investigators report a safety profile consistent with the interim analysis and no new safety signals. The most common adverse events in the abstract were anemia (66.4% vs 64.9%), neutropenia (58.0% vs 53.4%), leukopenia (56.8% vs 50.6%), increased ALT (33.2% vs 25.9%), thrombocytopenia (30.4% vs 23.1%), increased AST (30.4% vs 23.9%) and decreased appetite (30.0% vs 15.1%). Grade ≥3 adverse event rates are not reported in the abstract.
ESMO 2026 abstract LBA64 (programme; click Abstract under LBA64) · Annals of Oncology, Oct 26, 2026 (doi 10.1016/j.annonc.2026.10.094)At the interim analysis (data cutoff November 30, 2022; median follow-up 18.25 months; 404 stage III patients), EFS by investigator was HR 0.40 (95% CI 0.277–0.565), median not estimable vs 15.1 months, and pCR by BIPR was 24.8% vs 1.0%. The interim OS HR was 0.62 (95% CI 0.38–1.00). These results were presented at ASCO 2023 and published in JAMA in January 2024. They come from a different population and data cut than the final analysis.
JAMA 2024;331(3):201-211 (interim analysis) · Junshi Biosciences release, May 26, 2026✓ China (NMPA): toripalimab plus platinum doublet chemotherapy was approved in December 2023 as perioperative treatment for resectable stage IIIA–IIIB NSCLC, based on the interim analysis. Junshi Biosciences said in May 2026 that it plans a supplemental application to extend the approval to stage II–III NSCLC. ⚠ US and EU: investigational in lung cancer. In the US, LOQTORZI (toripalimab-tpzi, marketed by Coherus) is FDA approved only for nasopharyngeal carcinoma. In the EU, Loqtorzi is approved for nasopharyngeal carcinoma and esophageal squamous cell carcinoma.
Junshi Biosciences release, May 26, 2026 · FDA label, LOQTORZI (openFDA) · EMA, Loqtorzi EPAR · Annals of Oncology, Oct 26, 2026 (doi 10.1016/j.annonc.2026.10.094)Create a free account, pick the tumor types you cover, and go beyond the tweet — the intelligence pharma teams use to map influence and prepare for engagement:
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@jryckman3
Posted in 2023 about the interim analysis (stage III patients, data cutoff November 30, 2022), an earlier data cut than the final analysis presented at ESMO 2026.
#ESMO26 Dr. Shun Lu gives us the final analysis of the phase III Neotorch trial: perioperative toripalimab + chemotherapy for resectable stage II/III NSCLC. With 48.2m follow up, EFS 0.52 (median NR vs 20), MPR 47% vs 9%, pCR 26% vs 1%, OS HR 0.66. #ESMOAmbassadors https://t.co/4qsvyICFGa
🆙#ESMO26 Proffered Paper: #LCSM Non-Mets 🔥NEOTORCH: Toripalimab Plus Chemotherapy as Perioperative Treatment for Resectable Stage II or III Non-Small Cell Lung Cancer (NSCLC): Final Analysis of the Phase 3 Study 🎙️Dr. Shun Lu 🔢LBA64 🎯Significantly Improved EFS (NR vs 20.2mo, HR 0.52, p<0.0001; n=501) and OS (HR 0.66, p=0.0072) 🎯MPR 47.2% vs 9.2%, pCR 25.6% vs 1.2% ☑️NCT04158440 🔗 https://t.co/grEfaUchKN @OncoAlert @Larvol @myESMO @IASLC
🔥Neotorch Final Analysis: Perioperative toripalimab + chemo in resectable stage II/III NSCLC 🆙 @Annals_Oncology #ESMO26 🎙Dr. Ziming Li & Dr. Shun Lu 🎯Significantly Improved EFS (NR vs 20.2mo, HR 0.52, p<0.0001; n=501) and OS (HR 0.66, p=0.0072) 🎯MPR 47.2% vs 9.2%, pCR 25.6% vs 1.2% #LCSM @OncoAlert @Larvol https://t.co/7BSzito9TT
Improved EFS and OS w/ perioperative toripalimab in Neotorch (LBA64). 📌 Randomized, double-blind phase 3; final analysis (n=501 randomized), resectable stage II-III NSCLC. Toripalimab + platinum chemo vs placebo + platinum chemo perioperatively. 📌 Median follow-up 48.2 mo. mEFS NR vs 20.2 mo; HR 0.52 (95% CI 0.391-0.677). 📌 mOS NR in both arms; HR 0.66 (95% CI 0.486-0.894). 📌 Common AEs: neutropenia 58.0% vs 53.4%; decreased appetite 30.0% vs 15.1%. G≥3 AE rates aren't reported in the abstract. https://t.co/SCceCdT3GT #ESMO26 #LCSM
Posted on October 26, before the presentation, from the LBA64 abstract.
🆙 #ESMO26 Proffered Paper: #LCSM Non-Mets NSCLC, others 🔥NEOTORCH: Toripalimab Plus Chemotherapy as Perioperative Treatment for Resectable Stage II or III Non-Small Cell Lung Cancer 🎙️Dr. Shun Lu 🔢LBA64 🎯Final Analysis Met Primary Endpoints: EFS and MPR in Stage II-III Population ☑️NCT04158440 🔗 https://t.co/grEfaUbJVf @OncoAlert @Larvol @myESMO @IASLC
Posted on September 23, before the presentation.
Agree. My caution about having surgeons who don't meet quality criteria for st I-II NSCLC doing amateur hour surg for multistation N2 dzs applies to CM816, AEGEAN, NEOTORCH, KN-617, & NADIM2. This isn't broadly applicable strategy when you don't have same skill set as in study.
Posted in 2023 about the interim analysis (stage III patients, data cutoff November 30, 2022), an earlier data cut than the final analysis presented at ESMO 2026.
PeriOp/NeoAdj space in NSCLC post CM816, KN671, AEGEAN and NEOTORCH is obviously very exciting. But curious to see how these results play out in the real world given dramatically different surgical patterns in the community or rural settings (even when in controlled/clinical trial settings good amount of patients did not get to surgery). Great discussion by @JackWestMD here:
Posted in 2023 about the interim analysis (stage III patients, data cutoff November 30, 2022), an earlier data cut than the final analysis presented at ESMO 2026.
Important update. I am very interested in looking at other peri-operative trials’ (AEGEAN, NEOTORCH) long term outcomes. #ASCO23 #lungcancer #Immunotherapy
Posted in 2023 about the interim analysis (stage III patients, data cutoff November 30, 2022), an earlier data cut than the final analysis presented at ESMO 2026.
Neotorch asked whether adding toripalimab, an anti-PD-1 antibody, to perioperative platinum-based chemotherapy and continuing it as maintenance after surgery improves outcomes in resectable stage II–III NSCLC. The trial is sponsored by Shanghai Junshi Biosciences. Final results were presented by Shun Lu, MD, at ESMO 2026 (LBA64, Proffered paper: Non-metastatic NSCLC and other thoracic malignancies, October 26, 2026), with Jordi Remon Masip, MD, as invited discussant, and published in Annals of Oncology the same day (first author Ziming Li, MD).
Randomized 1:1, double-blind, placebo-controlled, multicenter phase 3 in China (NCT04158440; 55 hospitals); 250 vs 251 patients. Stratified by stage (II vs IIIA vs IIIB), lobectomy vs pneumonectomy, histology and PD-L1 (≥1% vs <1% or non-evaluable).
Treatment-naive resectable stage II, IIIA or IIIB (N2) NSCLC; EGFR/ALK-altered nonsquamous tumors excluded; 404 stage III and 97 stage II patients. Median age 62; 454 men and 47 women.
Toripalimab 240 mg or placebo Q3W plus platinum-based chemotherapy for 3 cycles before surgery and 1 cycle after surgery, then toripalimab or placebo monotherapy Q3W for up to 13 cycles.
Primary: EFS by investigator and MPR by BIPR, each in stage III and stage II–III. Secondary: OS, pCR, EFS by IRC, DFS, safety and feasibility of surgery.
Presenter and principal investigator: Shun Lu, MD (Shanghai Chest Hospital). Annals of Oncology first author: Ziming Li, MD. Invited discussant: Jordi Remon Masip, MD.
Final analysis: data cutoff April 18, 2026; median follow-up 48.2 months; OS maturity 34.3%. Interim analysis (stage III only): data cutoff November 30, 2022; median follow-up 18.25 months.
Neotorch (NCT04158440) is a randomized, double-blind, placebo-controlled phase 3 trial sponsored by Shanghai Junshi Biosciences. It enrolled 501 patients with resectable stage II or III NSCLC at 55 hospitals in China and compared toripalimab or placebo, each with platinum-based chemotherapy for 3 cycles before and 1 cycle after surgery, followed by toripalimab or placebo maintenance for up to 13 cycles. EGFR- or ALK-altered nonsquamous tumors were excluded.
At the final analysis (data cutoff April 18, 2026; median follow-up 48.2 months), investigator-assessed EFS in the stage II–III population was not reached vs 20.2 months, HR 0.52 (95% CI 0.391–0.677), P < 0.0001. Major pathological response by blinded independent review was 47.2% vs 9.2%. Both are primary endpoints in the stage II–III population and both were met at this analysis; MPR in stage III was also met, and stage III EFS had been met at the 2023 interim analysis. Results were presented by Shun Lu, MD (LBA64) and published in Annals of Oncology the same day.
Overall survival is a secondary endpoint. At the final analysis there were 73 vs 99 deaths (34.3% maturity), medians were not reached in either arm, and the HR was 0.66 (95% CI 0.49–0.89), P = 0.0072. The LBA64 abstract and the Annals of Oncology paper describe the OS improvement as statistically significant. At the 2023 interim analysis (stage III only), the OS HR was 0.62 (0.38–1.00).
The interim analysis (data cutoff November 30, 2022; median follow-up 18.25 months) covered stage III patients only (404 patients) and reported EFS HR 0.40 (95% CI 0.277–0.565) and pCR by blinded review of 24.8% vs 1.0%, published in JAMA in 2024. The final analysis covers all 501 stage II and III patients with longer follow-up: EFS HR 0.52, pCR 25.6% vs 1.2%. The two analyses use different populations and data cuts and should not be compared directly.
In China only. The NMPA approved toripalimab plus platinum doublet chemotherapy as perioperative treatment for resectable stage IIIA–IIIB NSCLC in December 2023, based on the interim analysis; Junshi said in May 2026 that it planned to submit a supplemental application to extend this to stage II–III. In the US, LOQTORZI (toripalimab-tpzi, Coherus) is FDA approved only for nasopharyngeal carcinoma, and in the EU Loqtorzi is approved only for nasopharyngeal carcinoma and esophageal squamous cell carcinoma. Perioperative toripalimab for NSCLC is investigational in the US and EU.
In exploratory subgroups, the EFS hazard ratio was 0.41 (0.264–0.631) for PD-L1 1–49% and 0.47 (0.262–0.812) for PD-L1 ≥50%. For PD-L1 <1% (129 patients) it was 0.72 (0.436–1.191), with a confidence interval that crosses 1. These subgroups were not powered for separate conclusions.