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A Chinese trial showing that adding the PD-1 antibody toripalimab to chemotherapy before and after lung cancer surgery more than doubles the time before the cancer comes back.
Neotorch enrolled 501 patients with resectable stage II or III non-small-cell lung cancer at 50 hospitals in China between March 2020 and June 2023, randomising them 1:1 to toripalimab or placebo with platinum-based chemotherapy for three cycles before surgery and one after, followed by toripalimab or placebo alone for up to 13 cycles. Non-squamous tumours had to be free of EGFR and ALK alterations. The dual primary endpoints were investigator-assessed event-free survival and blinded independently reviewed major pathological response.
The interim analysis, with a data cutoff of 30 November 2022, reported the 404 stage III patients (202 in each arm); the 97 stage II patients were excluded from it. Median age was 62, 92 percent were male and median follow-up was 18.3 months. Median event-free survival was not estimable (95 percent confidence interval 24.4 months to not estimable) with toripalimab against 15.1 months (10.6 to 21.9) with placebo, a hazard ratio of 0.40 (0.28 to 0.57).
Neotorch is one of four perioperative trials, with KEYNOTE-671, AEGEAN and CheckMate 77T, that made chemotherapy plus a checkpoint inhibitor before and after surgery a standard for stage II to III disease. Its population is almost entirely Chinese and male, which limits how far it transfers.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
501 enrolled.
median not estimable (95 percent confidence interval 24.4 to not estimable)
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival (stage III population)primary | Toripalimab with chemotherapy | 202 | median not estimable (95 percent confidence interval 24.4 to not estimable) | 0.4 (0.28 to 0.57) | - | link |
| Placebo with chemotherapy | 202 | 15.1 months |
Shares Toripalimab, Cisplatin, Platinum agents, Carboplatin.
Shares KEYNOTE-671, Neoadjuvant / adjuvant / perioperative, Resectable stage I to III non-small-cell lung cancer, PD-1.
Shares Resectable stage I to III non-small-cell lung cancer, Cisplatin, Platinum agents, Carboplatin.
Shares A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer, A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer, Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative.
Shares Shanghai Junshi Biosciences, Toripalimab, Cytotoxic chemotherapy, Immune checkpoint inhibitors.
Shares Resectable stage I to III non-small-cell lung cancer, Platinum agents, Carboplatin, Cytotoxic chemotherapy.
Shares Resectable stage I to III non-small-cell lung cancer, Platinum agents, Carboplatin, Cytotoxic chemotherapy.
Shares Resectable stage I to III non-small-cell lung cancer, Cisplatin, Platinum agents, Cytotoxic chemotherapy.