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ShanghaiMay 26, 2026 /PRNewswire/ — Junshi Biosciences (1877.HK, 688180.SH) announced that the randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (NEOTORCH, NCT04158440) of toripalimab, an anti-PD-1 monoclonal antibody independently developed by the company, in combination with platinum-based doublet chemotherapy for perioperative treatment of patients with stage II-III resectable non-small cell lung cancer (NSCLC) has completed its final analysis. The primary endpoints—event-free survival (EFS) in the stage II-III population, major pathological response (MPR) rate in the stage II-III population, and MPR rate in the stage III population—all met the pre-specified superiority thresholds. Detailed data from this study will be presented at an upcoming international academic conference. The company plans to submit a supplemental application to regulatory authorities in the near future to expand the indication from perioperative treatment of patients with resectable stage III NSCLC to perioperative treatment of patients with resectable stage II-III NSCLC.
Lung cancer is currently the malignancy with the highest incidence and mortality rates worldwide1. According to statistics, in 2022, lung cancer cases in China accounted for 22% (1.061 million) of new cancer cases and 28.5% (733,000) of cancer deaths2. NSCLC is the main subtype of lung cancer, accounting for approximately 85% of all cases3. Among these, 20-25% of patients are diagnosed at a stage where surgical resection is possible4, but even after curative surgery, 30-55% of patients experience recurrence and death5,6.
In recent years, immunotherapy represented by PD-(L)1 inhibitors has been reshaping the landscape of cancer treatment. By relieving the immunosuppressive effects of tumor cells on immune cells, these drugs can reactivate the patient’s own immune cells to kill tumors, achieving long-term control or elimination of the tumor. PD-(L)1 inhibitors have been recommended by both domestic and international authoritative lung cancer treatment guidelines as one of the standard perioperative treatments for operable stage II-III NSCLC.
The NEOTORCH study is a randomized, double-blind, placebo-controlled Phase III clinical trial designed to compare the efficacy and safety of toripalimab or placebo in combination with chemotherapy for perioperative treatment of patients with stage II/III resectable NSCLC. The study was led by Professor Shun Lu from Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, as the principal investigator, and enrolled a total of 501 patients with stage II-III resectable NSCLC. The primary endpoints were investigator-assessed EFS in stage III and stage II-III patients, and MPR rate assessed by blinded independent central pathology (BIPR) in stage III and stage II-III patients. Secondary endpoints included overall survival (OS), EFS assessed by an independent review committee (IRC), complete pathological response (pCR) rate, disease-free survival (DFS), and safety.
In January 2023, the interim analysis of EFS in stage III resectable NSCLC patients from the NEOTORCH study met its primary endpoint. The latest research results were presented as an oral report at the 2023 American Society of Clinical Oncology (ASCO) Plenary Series April session and the ASCO Annual Meeting, and were published in the top international journal Journal of the American Medical Association (JAMA) in January 20247, marking it as the world’s first Phase III clinical study of an anti-PD-1 monoclonal antibody for perioperative treatment (covering neoadjuvant and adjuvant therapy) of NSCLC to achieve a positive EFS result. Results showed that perioperative treatment with toripalimab plus chemotherapy, compared with perioperative chemotherapy alone, significantly prolonged EFS (median EFS: not reached vs. 15.1 months, P<0.001), reducing the risk of disease recurrence, progression, or death by 60% (HR=0.40, 95% CI: 0.28-0.57). Additionally, the toripalimab plus chemotherapy group showed a clear trend toward OS benefit (HR=0.62, 95% CI: 0.38-1.00). Furthermore, perioperative treatment with toripalimab plus chemotherapy increased the pCR rate by nearly 25-fold (pCR rate: 24.8% vs. 1.0%) and the MPR rate by nearly 6-fold (MPR rate: 48.5% vs. 8.4%).
In December 2023, based on the interim analysis results of the NEOTORCH study, the new indication for toripalimab in combination with platinum-based chemotherapy for perioperative treatment of patients with resectable stage IIIA-IIIB NSCLC was approved. This is China’s first and the world’s second approved perioperative therapy for lung cancer and has been included in the National Reimbursement Drug List (2025 version). This therapy has also received the highest level of recommendation in the 2024 edition of the CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer, setting a new benchmark for perioperative lung cancer treatment.
1. This material is intended to convey cutting-edge information and is not intended to promote any product to you or serve as clinical medication guidance.
2. If you wish to learn about specific disease diagnosis and treatment information, please follow the advice and guidance of healthcare professionals.
[References]
- https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf
- https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
- Planchard D, et al.. Ann Oncol 2018; 29 S4: iv192-iv237.
- Uramoto H, et al. Transl Lung Cancer Res 2014;3:242-9.
About the NEOTORCH Study
All enrolled patients were randomly assigned in a 1:1 ratio to receive perioperative treatment with either toripalimab plus chemotherapy or placebo plus chemotherapy, consisting of 3 cycles before surgery and 1 cycle after surgery, followed by 13 cycles of consolidation therapy with toripalimab or placebo (i.e., the “3+1+13” treatment regimen). The study was stratified by disease stage (stage II vs. stage IIIA vs. stage IIIB), PD-L1 expression status (≥1% vs. <1% or not evaluable), planned surgical procedure (pneumonectomy vs. lobectomy), and histological type (squamous cell carcinoma vs. non-squamous cell carcinoma).
About Toripalimab Injection (Tuoyi®)
Toripalimab injection (Tuoyi®), as the first domestically produced PD-1-targeted monoclonal antibody approved for marketing in China, has received support from the National Major Science and Technology Project and has been honored with the highest national patent award, the “China Patent Gold Award.”
To date, toripalimab has conducted over 40 company-initiated clinical studies covering more than 15 indications globally (including China, the United States, Europe, and Southeast Asia). Ongoing or completed pivotal registration clinical studies are evaluating the safety and efficacy of toripalimab across multiple tumor types, including lung cancer, nasopharyngeal carcinoma, esophageal cancer, gastric cancer, bladder cancer, breast cancer, liver cancer, renal cancer, and skin cancer.
As of now, toripalimab has been approved for 13 indications in mainland China: [1] For the treatment of unresectable or metastatic melanoma that has failed prior systemic therapy (December 2018); [2] For the treatment of recurrent/metastatic nasopharyngeal carcinoma that has failed at least two prior systemic therapies (February 2021); [3] For the treatment of locally advanced or metastatic urothelial carcinoma that has progressed within 12 months of platinum-containing chemotherapy, including neoadjuvant or adjuvant therapy (April 2021); [4] In combination with cisplatin and gemcitabine for first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (November 2021); [5] In combination with paclitaxel and cisplatin for first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (May 2022); [6] In combination with pemetrexed and platinum for first-line treatment of patients with epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK)-negative, unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (September 2022); [7] In combination with chemotherapy for perioperative treatment, followed by monotherapy as adjuvant therapy, for adult patients with resectable stage IIIA-IIIB non-small cell lung cancer (December 2023); [8] In combination with axitinib for first-line treatment of patients with intermediate- or high-risk unresectable or metastatic renal cell carcinoma (April 2024); [9] In combination with etoposide and platinum for first-line treatment of extensive-stage small cell lung cancer (June 2024); [10] In combination with nab-paclitaxel for first-line treatment of recurrent or metastatic triple-negative breast cancer with PD-L1 positive (CPS≥1) as assessed by a fully validated test (June 2024); [11] In combination with bevacizumab for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (March 2025); [12] For first-line treatment of unresectable or metastatic melanoma (April 2025); [13] In combination with disitamab vedotin for first-line treatment of HER2-expressing urothelial carcinoma (May 2026). In December 2020, toripalimab was first included in the National Reimbursement Drug List through negotiation. Currently, all 12 indications approved before 2026 have been included in the National Reimbursement Drug List (2025 version), making it the only anti-PD-1 monoclonal antibody in the list for the treatment of melanoma, renal cancer, and triple-negative breast cancer. Three indications of toripalimab for the treatment of advanced nasopharyngeal carcinoma and esophageal squamous cell carcinoma have been approved in Hong Kong, China.
In terms of international expansion, toripalimab has been approved for marketing in countries and regions including the United States, the European Union, India, the United Kingdom, Australia, and Singapore, and is under regulatory review in multiple other countries and regions globally.
About Junshi Biosciences
Junshi Biosciences (688180.SH, 1877.HK), founded in December 2012, is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies. Leveraging its outstanding innovative drug discovery capabilities, strong biotechnology R&D capabilities, and large-scale production capacity, the company has successfully developed a competitive drug portfolio and built a pipeline with a tiered structure, covering therapeutic areas such as malignant tumors, autoimmune diseases, chronic metabolic diseases, and infectious diseases. The innovation areas include monoclonal antibodies, small molecules, antibody-drug conjugates (ADCs), bispecific/multispecific antibodies, fusion proteins, nucleic acid drugs, vaccines, and other cutting-edge directions. To date, the company has commercialized five products domestically or internationally, including the PD-1 inhibitor toripalimab (Tuoyi®), which was independently developed in China and approved for marketing in over 40 countries and regions, including China, the United States, and Europe.
With the mission of “providing patients with world-class, trustworthy, and innovative medicines,” Junshi Biosciences is rooted in China and expanding globally. Currently, the company has nearly 3,000 employees worldwide, primarily located in Maryland, USA, and Shanghai, Suzhou, Beijing, and Guangzhou, China.
Official website: www.junshipharma.com
Official WeChat: Junshi Biosciences