Junshi Biosciences Announces JAMA Publication of Results from NEOTORCH, a Randomized Phase 3 Trial of Perioperative Toripalimab plus Chemotherapy for Patients with Resectable Non-Small Cell Lung Cancer

SHANGHAI, China, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced the publication of results from the prespecified interim analysis for event-free survival (EFS) in patients with stage III non-Small Cell Lung Cancer (NSCLC) of NEOTORCH (NCT04158440) in the Journal of the American Medical Association (JAMA). NEOTORCH is a randomized, double-blind, placebo-controlled phase 3 trial evaluating the efficacy and safety of toripalimab in combination with perioperative platinum-based chemotherapy vs chemotherapy alone in patients with resectable stage II or III NSCLC.

NEOTORCH is the world's first phase III clinical study of a anti-PD-1 monoclonal antibody for NSCLC perioperative treatment (including neoadjuvant and adjuvant) with positive EFS results. NEOTORCH's latest study results were announced in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Plenary Series held last April, as well as during the 2023 ASCO annual meeting.

"Whether it is clinical diagnosis and treatment level or clinical research ability, we have gradually transformed from a ?follower' to an ?equal,' even becoming a ?leader' in certain aspects. An increasing number of innovative solutions are originating from China and going global, ultimately changing international treatment standards. The publication of NEOTORCH by JAMA is a starting point. China's ?3+1+13' perioperative treatment model has the highest evidence-based medical value and will establish new treatment standards for patients, bringing transformative changes to the diagnosis and treatment landscape of lung cancer in China and beyond," said NEOTORCH's principal investigator, Dr. Shun LU of the Shanghai Chest Hospital within Shanghai Jiaotong University.

As a phase 3 clinical study of perioperative treatment, NEOTORCH enrolled the largest sample of resectable stage III NSCLC patients in China. Of the 501 randomized patients, 404 stage III NSCLC (202 in the toripalimab + chemotherapy group and 202 in the placebo + chemotherapy group) were included in this interim analysis. Patients were randomized in a 1:1 ratio to receive toripalimab or placebo, once every 3 weeks combined with platinum-based chemotherapy for 3 cycles before and 1 cycle after surgery, followed by toripalimab only or placebo for up to 13 cycles.

As of November 30, 2022 (median follow-up of 18.3 months), results showed that the addition of toripalimab to perioperative chemotherapy led to a significant improvement in event-free survival for patients with resectable stage III NSCLC, and this treatment strategy had a manageable safety profile.

For the primary outcome of event-free survival (assessed by investigator), the median length was not estimable in the toripalimab group compared with 15.1 months in the placebo group (hazard ratio, 0.40 [95%CI, 0.28-0.57], P<0.001). The major pathological response rate (another primary outcome assessed by blinded, independent pathological review) was 48.5% in the toripalimab group compared with 8.4% in the placebo group. The pathological complete response rate (secondary outcome assessed by blinded, independent pathological review) was 24.8% in the toripalimab group compared with 1.0% in the placebo group.

Of the 82.2%(166/202) of patients in the toripalimab group and 73.3% (148/202) of patients in the placebo group who underwent surgery, 95.8%and 92.6%, respectively, had their resections classified as R0. Among the patients who underwent surgery, the median length of disease-free survival (assessed by the investigators) was not estimable vs. 19.3 months, respectively (HR, 0.50 [95% CI, 0.33-0.76], P<0.001). The median length of overall survival was not estimable in the toripalimab group compared with 30.4 months in the placebo group (HR, 0.62 [95% CI, 0.38-1.00]).

"NEOTORCH's significant research findings have been published by JAMA, underscoring the international academic community's recognition of toripalimab and the world's first ?3+1+13' perioperative immunotherapy model for lung cancer. We anticipate that toripalimab will guide China's perioperative lung cancer treatment into a new era. Junshi Biosciences will also continue to innovate, and we aim to bring more advanced and improved treatment options to patients," said Dr. Jianjun ZOU, General Manager and Chief Executive Officer of Junshi Biosciences.

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system's ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are seven approved indications for toripalimab in China:

1. unresectable or metastatic melanoma after failure of standard systemic therapy;
2. recurrent or metastatic nasopharyngeal carcinoma ("NPC") after failure of at least two lines of prior systemic therapy;
3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
5. in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
6. in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
7. in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC.
   

The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma.

In the United States, the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).

In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.

In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (TGA) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Four of the company's innovations have already reached the Chinese or international markets, one of which is toripalimab, China's first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in China and the US. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.

With a mission of "providing patients with world-class, trustworthy, affordable, and innovative drugs", Junshi Biosciences is "In China, For Global." At present, the company boasts approximately 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com.

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