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KOL Pulse · AI-Native Trial Intelligence

Neotorch Trial

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).

ESMO 2026 · LBA64 · Annals of Oncology Phase III · NCT04158440 Resectable stage II–III NSCLC · perioperative Toripalimab + chemo vs placebo + chemo Final analysis · median follow-up 48.2 mo · China Approved in China (NMPA, stage IIIA–IIIB) · not FDA/EMA approved for NSCLC
See the LBA64 Results →

Neotorch Key Takeaways

Endpoint hierarchy

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 NCT04158440

Primary endpoint met: event-free survival, stage II–III

Median 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 mo
LBA64 presentation slides (Shun Lu, ESMO 2026) · ESMO 2026 abstract LBA64 (programme; click Abstract under LBA64) · Annals of Oncology, Oct 26, 2026 (doi 10.1016/j.annonc.2026.10.094)

Primary endpoint met: major pathological response

By 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%
LBA64 presentation slides (Shun Lu, ESMO 2026) · ESMO 2026 abstract LBA64 (programme; click Abstract under LBA64)

Overall survival (secondary endpoint)

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% maturity
LBA64 presentation slides (Shun Lu, ESMO 2026) · ESMO 2026 abstract LBA64 (programme; click Abstract under LBA64) · Annals of Oncology, Oct 26, 2026 (doi 10.1016/j.annonc.2026.10.094)

PD-L1 subgroups (exploratory)

EFS 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)

Safety

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)

Earlier data cut: the 2023 interim analysis (stage III only)

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

Regulatory status & clinical implications

✓ 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)

Sources: ESMO 2026 abstract LBA64 and presentation (Shun Lu, MD, October 26, 2026); Annals of Oncology (Li ZM, et al., published October 26, 2026, doi 10.1016/j.annonc.2026.10.094); Junshi Biosciences release (May 26, 2026); JAMA 2024;331(3):201-211 (interim analysis); ClinicalTrials.gov NCT04158440. FDA and EMA status checked against the FDA label database and the EMA medicine page on October 26, 2026. Slides were shared on X by the physicians credited in Key Slides.

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Top KOLs Discussing Neotorch

The physicians whose Neotorch posts drew the most views, including posts on the 2023 interim analysis. The presenter, Shun Lu, MD (Shanghai Chest Hospital, Shanghai Jiao Tong University), has no X profile we could verify; his slides are in Key Slides. The invited discussant was Jordi Remon Masip, MD (Villejuif, France).

Neotorch Key Slides & Visuals

ESMO 2026 slides

The LBA64 final-analysis presentation (presenter: Shun Lu, MD), as photographed and shared on X by physicians on October 26, plus the Annals of Oncology graphical abstract and the abstract. The last group shows the 2023 interim analysis, an earlier data cut in stage III patients only. Survival curves and response data are summarized in number tables under the slide groups. Click any image to view it full size, and open the transcribed text under each group. All ESMO 2026 Neotorch slides in the KOL Pulse slide library →

Stephen V Liu, MD
Stephen V Liu, MD@StephenVLiu
Presenter, EFS, pathological response and overall survival
Oct 26, 2026 · ESMO 2026 · LBA64
View post on X ↗
Event-free survival, stage II–III (primary endpoint by investigator), final analysis, data cutoff Apr 18, 2026, median follow-up 48.2 months, as printed on the LBA64 slide
Toripalimab + chemo (n=250)Placebo + chemo (n=251)HR (95% CI), P
Median EFS by investigator, months (95% CI)NR (51.3–NE)20.2 (14.3–24.8)0.52 (0.391–0.677), P < 0.0001
EFS rate by investigator at 24 / 36 months71.5% / 63.1%45.5% / 40.6%—
Median EFS by IRC (secondary), months (95% CI)NR (NE–NE)22.6 (15.1–45.8)0.53 (0.395–0.701), P < 0.0001
EFS rate by IRC at 24 / 36 months70.1% / 64.0%48.4% / 44.5%—
Pathological response by blinded independent pathologic review (BIPR), stage II–III, as printed on the LBA64 slide and abstract
Toripalimab + chemo (n=250)Placebo + chemo (n=251)Difference (95% CI), P
MPR (primary endpoint), % (95% CI)47.2 (40.9–53.6)9.2 (5.9–13.4)38% (31–45), P < 0.0001
pCR (secondary endpoint), % (95% CI)25.6 (20.3–31.5)1.2 (0.2–3.5)24% (19–30), P < 0.0001
Overall survival, stage II–III (secondary endpoint), final analysis, data cutoff Apr 18, 2026, maturity 34.3%, as printed on the LBA64 slide
Toripalimab + chemo (n=250)Placebo + chemo (n=251)HR (95% CI), P
Deaths, n (%)73 (29.2)99 (39.4)—
Median OS, months (95% CI)NR (NE–NE)NR (58.6–NE)0.66 (0.49–0.89), P = 0.0072
OS rate at 24 / 36 months84% / 78%78% / 67%—
Slide text (transcribed from the slide images) [Photo] Shun Lu, MD, presenting LBA64 at the ESMO Congress 2026 podium, Madrid, 23-27 October 2026. [EFS in Stage II and III Patients] (Kaplan-Meier curves; key numbers below) EFS by investigator. Median follow-up: 48.2 months. Median (95% CI): toripalimab NR (51.3, NE); placebo 20.2 (14.3, 24.8). HR (95% CI) 0.52 (0.391, 0.677). P-value <0.0001. Landmarks: 24 months 71.5 vs 45.5; 36 months 63.1 vs 40.6. No. at risk (0, 12, 24, 36, 48, 60, 72 mo): Toripalimab 250, 173, 139, 109, 76, 17, 0; Placebo 251, 133, 94, 75, 52, 13, 0 EFS by IRC. Median follow-up: 48.2 months. Median (95% CI): toripalimab NR (NE, NE); placebo 22.6 (15.1, 45.8). HR (95% CI) 0.53 (0.395, 0.701). P-value <0.0001. Landmarks: 24 months 70.1 vs 48.4; 36 months 64.0 vs 44.5. No. at risk: Toripalimab 250, 167, 130, 105, 74, 16, 0; Placebo 251, 122, 88, 73, 50, 11, 0 NR, not reached; NE: not estimable; HR: hazard ratio; CI: confidence interval. Data cutoff date: April 18, 2026 Shun Lu [Pathological response in Stage II and III Patients] MPR by BIPR: Difference = 38% (95% CI: 31, 45); P < 0.0001. Toripalimab + chemo 47.2; Placebo + chemo 9.2 pCR by BIPR: Difference = 24% (95% CI: 19, 30); P < 0.0001. Toripalimab + chemo 25.6; Placebo + chemo 1.2 HR: hazard ratio; CI: confidence interval. Data cutoff date: April 18, 2026 Shun Lu [Overall Survival in Stage II and III Patients] (Kaplan-Meier curve; key numbers below) Median follow-up: 48.2 months; maturity: 34.3% Toripalimab vs Placebo: N 250 vs 251; Events, n (%) 73 (29.2) vs 99 (39.4); Median OS (95% CI), mo NR (NE, NE) vs NR (58.6, NE); HR (95% CI) 0.66 (0.49, 0.89); P-value 0.0072 Landmarks: 24 months 84% vs 78%; 36 months 78% vs 67% No. at risk (censored), 0/12/24/36/48/60/72 mo: Toripalimab 250 (0), 232 (6), 203 (9), 179 (18), 142 (42), 71 (106), 1 (176); Placebo 251 (0), 220 (10), 184 (15), 148 (24), 109 (53), 50 (103), 1 (151) NR, not reached; NE, not estimable; HR: hazard ratio; CI: confidence interval. Data cutoff date: April 18, 2026 Shun Lu
Hidehito HORINOUCHI
Study design, EFS, PD-L1 subgroups and pathological response
Oct 26, 2026 · ESMO 2026 · LBA64
View post on X ↗
EFS by tumor PD-L1 expression (exploratory subgroups), as printed on the LBA64 slide
PD-L1 (tumor cells)Patients (toripalimab / placebo)Median EFS, monthsHR (95% CI)
<1% (n=129)63 / 6651.3 vs 20.20.72 (0.436–1.191)
1–49% (n=164)85 / 7940.9 vs 15.40.41 (0.264–0.631)
≥50% (n=157)75 / 82NR vs NR0.47 (0.262–0.812)
Slide text (transcribed from the slide images) [Neotorch Study Design] Newly diagnosed resectable stage II-III NSCLC; EGFR/ALK wild type; biopsy tissue available for biomarker analysis; measurable lesion(s) 1:1 (N=501) Neoadjuvant*: Toripalimab 240mg + platinum-based chemotherapy Q3W 3 cycles | Placebo + platinum-based chemotherapy Q3W 3 cycles SURGERY Adjuvant: Toripalimab 240mg + platinum-based chemotherapy Q3W 1 cycle | Placebo + platinum-based chemotherapy Q3W 1 cycle Maintenance: Toripalimab 240mg Q3W up to 13 cycles | Placebo Q3W up to 13 cycles Follow Up Primary endpoints: EFS by investigator (stage III); EFS by investigator (stage II-III); MPR by BIPR (stage III); MPR by BIPR (stage II-III) Secondary endpoints: Overall survival; pCR by BIPR/site pathologist for stage III and stage II-III; EFS by IRC for stage III and stage II-III; Disease-free survival; Safety and feasibility of surgery Stratification factors: II vs IIIA vs IIIB; Lobectomy vs pneumonectomy; Non-squamous vs squamous; PD-L1 TC expression: >= 1% vs < 1% or non-evaluable EFS: event-free survival; MPR: major pathological response; pCR: pathologic complete response; BIPR: blinded independent pathologic review; IRC: independent review committee * 3 cycles of neoadjuvant chemotherapy with 4 cycles of peri-operative chemotherapy in total were required with in Neotorch study, meanwhile, surgeons were allowed to determine the most appropriate timing for surgery based on the patient's condition. Shun Lu [EFS in Stage II and III Patients] (Kaplan-Meier curves; key numbers below) EFS by investigator. Median follow-up: 48.2 months. Median (95% CI): toripalimab NR (51.3, NE); placebo 20.2 (14.3, 24.8). HR (95% CI) 0.52 (0.391, 0.677). P-value <0.0001. Landmarks: 24 months 71.5 vs 45.5; 36 months 63.1 vs 40.6. No. at risk (0, 12, 24, 36, 48, 60, 72 mo): Toripalimab 250, 173, 139, 109, 76, 17, 0; Placebo 251, 133, 94, 75, 52, 13, 0 EFS by IRC. Median follow-up: 48.2 months. Median (95% CI): toripalimab NR (NE, NE); placebo 22.6 (15.1, 45.8). HR (95% CI) 0.53 (0.395, 0.701). P-value <0.0001. Landmarks: 24 months 70.1 vs 48.4; 36 months 64.0 vs 44.5. No. at risk: Toripalimab 250, 167, 130, 105, 74, 16, 0; Placebo 251, 122, 88, 73, 50, 11, 0 NR, not reached; NE: not estimable; HR: hazard ratio; CI: confidence interval. Data cutoff date: April 18, 2026 Shun Lu [EFS in Different PD-L1 Expression Subgroups] (Kaplan-Meier curves; key numbers below) PD-L1 < 1% (n=129): Median EFS 51.3 vs. 20.2 months; HR = 0.72 (95% CI 0.436-1.191). No. at risk at 0 months: Toripalimab 63, Placebo 66 PD-L1 1-49% (n=164): Median EFS 40.9 vs. 15.4 months; HR = 0.41 (95% CI 0.264-0.631). Toripalimab 85, Placebo 79 PD-L1 >= 50% (n=157): Median EFS NR vs. NR months; HR = 0.47 (95% CI 0.262-0.812). Toripalimab 75, Placebo 82 NR, not reached; HR: hazard ratio; CI: confidence interval. Data cutoff date: April 18, 2026 Shun Lu [Pathological response in Stage II and III Patients] MPR by BIPR: Difference = 38% (95% CI: 31, 45); P < 0.0001. Toripalimab + chemo 47.2; Placebo + chemo 9.2 pCR by BIPR: Difference = 24% (95% CI: 19, 30); P < 0.0001. Toripalimab + chemo 25.6; Placebo + chemo 1.2 HR: hazard ratio; CI: confidence interval. Data cutoff date: April 18, 2026 Shun Lu
Hidehito HORINOUCHI
Annals of Oncology graphical abstract
Oct 26, 2026 · Annals of Oncology · Oct 26, 2026
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Slide text (transcribed from the slide images) [Annals of Oncology graphical abstract] POPULATION: 454 Men, 47 Women. Adults with resectable Stage II or III NSCLC. Median age: 62 years. LOCATION: 55 Hospitals in China. INTERVENTION: 501 patients randomized. 250 Toripalimab: 240 mg of toripalimab plus chemotherapy. 251 Placebo: placebo plus chemotherapy. All patients received the neoadjuvant treatment. PRIMARY OUTCOME: Event-free survival and major pathological response rate. FINDINGS: Median event-free survival (months): Not reached vs 20.2. Major pathological response rate: 47% vs 9%. The results were significant: Hazard ratio for event-free survival, 0.52 (95% CI, 0.39 to 0.68), P <0.0001. Between-group difference for major pathological response rate, 38% (95% CI, 31% to 45%), P <0.0001.
Hidehito HORINOUCHI
Abstract LBA64 (ESMO 2026 programme)
Oct 26, 2026 · ESMO 2026 · LBA64
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Slide text (transcribed from the slide images) LBA64 - Toripalimab plus chemotherapy as perioperative treatment for resectable stage II or III non-small cell lung cancer (NSCLC): Final analysis of the phase 3 Neotorch study Speakers: Shun Lu (Shanghai, China). Session: Proffered paper: Non-metastatic NSCLC and other thoracic malignancies, Alicante Auditorium - Hall 6, Mon 26.10.2026, 14:45-16:15; lecture time 15:23-15:33. Invited Discussant LBA64, 2519O and 2511O: Jordi Remon Masip (Villejuif, France), 15:53-16:05. Authors: Shun Lu, Lin Wu, Wenxiang Wang, Longhua Sun, Peng Zhang, Wentao V. Fang, Zheng Yan, Qixun Chen, Lin Yang, Lijie Tan, Jiandong Mei, Jinlu Shan, Shidong Xu, Xiaohong Sun, Nong Yang, Xiaohua Hu, Guohua Yu, Dongliang Yu, Yuping Chen, Ligang Xing Background: In the interim analysis of the Neotorch study, perioperative toripalimab plus chemotherapy significantly improved the event-free survival (EFS) in patients with resectable stage III NSCLC. Here, we report the final analysis in patients with Stage II or III disease. Methods: Eligible adult patients with histologically confirmed resectable Stage II or III NSCLC (excluding patients with EGFR or ALK alterations for non-squamous NSCLC) were randomized 1:1 to receive 240 mg toripalimab or placebo once every 3 weeks (Q3W) plus platinum-based chemotherapy for 3 cycles before surgery, 1 cycle after surgery, followed by toripalimab or placebo monotherapy for up to 13 cycles. The primary endpoints were EFS assessed by investigators (INV-EFS) and major pathological response rate by a blinded independent pathologic review (BIPR) in Stage III and Stage II or III populations. Secondary endpoints included overall survival (OS), pathologic complete response (pCR) rate, and safety. Results: A total of 501 patients (404 Stage III, 97 Stage II) were randomized to toripalimab (n=250) or placebo (n=251) arms. By April 18, 2026, the median follow-up was 48.2 months. Baseline characteristics were well balanced between the 2 arms. The INV-EFS was significantly improved in the toripalimab arm (hazard ratio [HR]: 0.52; 95% CI: 0.391, 0.677; p <0.0001). The OS was also significantly prolonged in the toripalimab arm (HR: 0.66; 95% CI: 0.486, 0.894; p =0.0072). The BIPR-assessed MPR and pCR rates were much higher in the toripalimab arm (Table). The safety profile was consistent with the interim analysis, with no new safety signals identified. Table: Efficacy and safety summary. Toripalimab arm (n=250) vs Placebo arm (n=251) INV-EFS, median (95% CI), m: NR (51.3, NE) vs 20.2 (14.3, 24.8); HR (95% CI) 0.52 (0.391, 0.677); p <0.0001 BIPR-MPR rate (95% CI), %: 47.2 (40.9, 53.6) vs 9.2 (5.9, 13.4); p <0.0001 OS, median (95% CI), m: NR (NE, NE) vs NR (58.6, NE); HR (95% CI) 0.66 (0.486, 0.894); p 0.0072 BIPR-pCR (95% CI), %: 25.6 (20.3, 31.5) vs 1.2 (0.2, 3.5); p <0.0001 Common adverse events, n (%): Anaemia 166 (66.4) vs 163 (64.9); Neutropenia 145 (58.0) vs 134 (53.4); Leukopenia 142 (56.8) vs 127 (50.6); Alanine aminotransferase increased 83 (33.2) vs 65 (25.9); Thrombocytopenia 76 (30.4) vs 58 (23.1); Aspartate aminotransferase increased 76 (30.4) vs 60 (23.9); Decreased appetite 75 (30.0) vs 38 (15.1) NR, not reached; NE, not estimable. Conclusions: The addition of toripalimab to perioperative chemotherapy showed significant and clinically meaningful improvements in EFS, MPR rate, and OS for resectable Stage II or III NSCLC patients with a manageable safety profile.
Drew Moghanaki
Drew Moghanaki@DrewMoghanaki
2023 interim analysis (stage III, earlier data cut): design, EFS, pCR and immune-related AEs
Apr 23, 2023 · 2023 · Interim
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Interim analysis, stage III patients only (earlier data cut: Nov 30, 2022, median follow-up 18.25 months), as printed on the 2023 slides
Toripalimab + chemo (n=202)Placebo + chemo (n=202)HR or difference (95% CI)
EFS events / median EFS, months (95% CI)47 / NE (24.4–NE)97 / 15.1 (10.6–21.9)HR 0.40 (0.277–0.565), two-sided P < 0.0001 (boundary 0.01683)
EFS rate at 1 / 2 years84.4% / 64.7%57.0% / 38.7%—
pCR by BIPR, n (%)50 (24.8)2 (1.0)23.7 (17.6–29.8), nominal P < 0.0001
Slide text (transcribed from the slide images) [Neotorch Study Design] (2023 interim presentation) Neotorch is a randomized, double-blind, placebo-controlled, Phase III trial evaluating the efficacy and safety of perioperative toripalimab plus chemotherapy, followed by toripalimab maintenance vs perioperative chemotherapy alone in resectable stage II/III non-small cell lung cancer (NSCLC). Newly diagnosed resectable stage II-III NSCLC; EGFR/ALK wild type; biopsy tissue available for biomarker analysis; evaluable lesions; planned enrollment N=500. 1:1. Neoadjuvant: Toripalimab 240mg + platinum-based chemotherapy Q3W 3 cycles | Placebo + platinum-based chemotherapy Q3W 3 cycles. SURGERY. Adjuvant: Q3W 1 cycle. Maintenance: Toripalimab 240mg / Placebo Q3W up to 13 cycles. Follow up. Primary endpoints: EFS by investigator (stage III); EFS by investigator (stage II-III); MPR evaluated by BIPR (stage III); MPR evaluated by BIPR (stage II-III) Secondary endpoints: Overall survival; pCR by BIPR/site pathologist for stage III and stage II-III; EFS by IRC for stage III and stage II-III; Disease-free survival; Safety and feasibility of surgery Stratification factors: II vs IIIA vs IIIB; Lobectomy vs pneumonectomy; Non-squamous vs squamous; PD-L1 TC expression: >= 1% vs < 1% or non-evaluable [Event-Free Survival Analysis by Investigator] (2023 interim; Kaplan-Meier curve; key numbers below) Intent-to-treat Stage III patients assessed by investigator per RECIST v1.1 Toripalimab + Chemo: 47/202 events; median EFS NE (24.4, NE). Placebo + Chemo: 97/202; 15.1 (10.6, 21.9) 1-Yr EFS rate 84.4% vs 57.0%; 2-Yr EFS rate 64.7% vs 38.7% Median follow-up: 18.25 months. HR 0.40 (95%CI 0.277, 0.565); two-sided P<0.0001; 2-sided efficacy boundary: 0.01683 Data cutoff date: Nov. 30, 2022 [Pathological Complete Response] (2023 interim; stage III) Toripalimab + Chemo (N=202) vs Placebo + Chemo (N=202) pCR assessed by local pathologist: n (%) 57 (28.2) vs 2 (1.0); 95% CI 22.1, 35.0 vs 0.1, 3.5; stratified difference between arms (95% CI) 27.2 (20.8, 33.5); P value <0.0001 pCR assessed by BIPR: n (%) 50 (24.8) vs 2 (1.0); 95% CI 19.0, 31.3 vs 0.1, 3.5; stratified difference between arms (95% CI) 23.7 (17.6, 29.8); P value <0.0001 pCR: Pathological Complete Response; IRC: Independent Review Committee; P-values are nominal [Immune-related Adverse Events] (2023 interim) Immune-related adverse events with an incidence of >=2%, grade 1-2 and grade >=3, toripalimab + chemo vs placebo + chemo (bar chart; individual values are not printed on the slide).

KOL-Made Infographics

Summary graphics designed or shared by physicians (not conference slides). Values are as the authors drew them. Click to enlarge.

Summary card on the Neotorch final analysis from the LBA64 abstract: median EFS NR vs 20.2 months, MPR 47.2% vs 9.2%, pCR 25.6% vs 1.2% (made by Jeff Ryckman)@jryckman3

Neotorch conversations on X

Full reply chains, in order, each post shown verbatim under its own author. In 2023, physicians also raised surgical quality and real-world applicability of perioperative regimens (H. Jack West, MD; Oncology Brothers); their posts are in Physician Reactions.

Physician reactions to Neotorch

Full, verbatim posts, newest first, linked to the originals; posts that are part of a reply chain are in Discussion Threads above. In all, 12 posts from 7 physician accounts: 5 from 2026 on the final analysis and 7 from 2023 on the interim analysis, which are labelled.

Stephen V Liu, MD
Stephen V Liu, MD@StephenVLiu

#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

407 views 3 likes2 RT 2026-10-26
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🆙#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

323 views 5 likes4 RT 2026-10-26
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🔥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

264 views 3 likes5 RT 2026-10-26
Jeff Ryckman
Jeff Ryckman@jryckman3

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.

227 views 0 likes1 RT 2026-10-26
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🆙 #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.

2K views 8 likes5 RT 2026-09-23
H. Jack West, MD, FASCO
H. Jack West, MD, FASCO@JackWestMD

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.

707 views 4 likes0 RT 2023-06-29
Oncology Brothers
Oncology Brothers@OncBrothers

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.

4.9K views 7 likes1 RT 2023-06-28
Anis Toumeh, MD
Anis Toumeh, MD@AnisToumeh

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.

57 views 0 likes0 RT 2023-05-25

Neotorch Trial Design

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).

Study Design

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).

Population

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.

Interventions

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.

Endpoints

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 & Discussant

Presenter and principal investigator: Shun Lu, MD (Shanghai Chest Hospital). Annals of Oncology first author: Ziming Li, MD. Invited discussant: Jordi Remon Masip, MD.

Data Cuts

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 in the News

Neotorch Questions

What is the Neotorch trial?

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.

What did the Neotorch final analysis show at ESMO 2026?

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.

Did toripalimab improve overall survival in Neotorch?

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).

How do the final results differ from the 2023 interim analysis?

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.

Is perioperative toripalimab approved for lung cancer?

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.

Who benefited by PD-L1 expression?

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.

Key KOL Sentiments - Neotorch

5 positive, 6 neutral and 1 negative posts from physicians, each shown verbatim.

PhysicianDateSentimentPost (verbatim)
Hidehito HORINOUCHI
Hidehito HORINOUCHI
@HHorinouchi
Oct 26, 2026 ● POSITIVE 🆙#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
Hidehito HORINOUCHI
Hidehito HORINOUCHI
@HHorinouchi
Oct 26, 2026 ● POSITIVE 🔥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
Jeff Ryckman
Jeff Ryckman
@jryckman3
Oct 26, 2026 ● POSITIVE 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.
Hidehito HORINOUCHI
Hidehito HORINOUCHI
@HHorinouchi
Sep 23, 2026 ● POSITIVE 🆙 #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.
Drew Moghanaki
Drew Moghanaki
@DrewMoghanaki
Apr 23, 2023 ● POSITIVE DRUM ROLL: Within a week of learning AEGEAN's results, a 3rd randomized phase III trial demonstrates the benefit of adding a PD-1 inhibitor to platinum-based neoadjuvant chemotherapy. This time, the pCR rate = 25%. #Neotorch #ASCO23 https://t.co/4IJnrAyX2r
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.
Stephen V Liu, MD
Stephen V Liu, MD
@StephenVLiu
Oct 26, 2026 ● NEUTRAL #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
Jun 29, 2023 ● NEUTRAL 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.
Oncology Brothers
Oncology Brothers
@OncBrothers
Jun 28, 2023 ● NEUTRAL 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.
Anis Toumeh, MD
Anis Toumeh, MD
@AnisToumeh
May 25, 2023 ● NEUTRAL 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.
Drew Moghanaki
Drew Moghanaki
@DrewMoghanaki
Apr 23, 2023 ● NEUTRAL The subgroup analyses are intriguing. https://t.co/UfUnccS28G
Drew Moghanaki
Drew Moghanaki
@DrewMoghanaki
Apr 23, 2023 ● NEUTRAL More subgroup analyses, also intriguing. https://t.co/vxz8Md5da4
Drew Moghanaki
Drew Moghanaki
@DrewMoghanaki
Apr 23, 2023 ● NEGATIVE Once again, many participants (22%) who were started on systemic therapy didn't make it to surgery. By comparison: CM816 = 20%, AEGEAN = 19%. Are any of these people being harmed by delaying concurrent chemoRT with the hopes that they'll make it to the "pCR Winner's Circle"? https://t.co/8UZY0OyzUc

Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated October 26, 2026. Every quote verbatim; every number checked against the ESMO 2026 LBA64 abstract and presentation slides, the Annals of Oncology publication, the Junshi Biosciences release, the JAMA interim publication or ClinicalTrials.gov, with the source labelled.

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