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

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SHANGHAI, China, Jan. 17, 2024 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a number one innovation-driven biopharmaceutical firm devoted to the invention, growth, and commercialization of novel therapies, introduced the publication of outcomes from the prespecified interim evaluation for event-free survival (EFS) in sufferers with stage III non-Small Cell Lung Most cancers (NSCLC) of NEOTORCH (NCT04158440) in the
Journal of the American Medical Association (JAMA). NEOTORCH is a randomized, double-blind, placebo-controlled part 3 trial evaluating the efficacy and security of toripalimab together with perioperative platinum-based chemotherapy vs chemotherapy alone in sufferers with resectable stage II or III NSCLC.

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NEOTORCH is the world’s first part III scientific research of a anti-PD-1 monoclonal antibody for NSCLC perioperative remedy (together with neoadjuvant and adjuvant) with optimistic EFS outcomes. NEOTORCH’s newest research outcomes have been introduced in an oral presentation on the 2023 American Society of Medical Oncology (ASCO) Plenary Sequence held final April, in addition to in the course of the 2023 ASCO annual assembly.

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“Whether or not it’s scientific prognosis and remedy degree or scientific analysis capability, now we have regularly remodeled from a ‘follower’ to an ‘equal,’ even changing into a ‘chief’ in sure features. An growing variety of progressive options are originating from China and going international, finally altering worldwide remedy requirements. The publication of NEOTORCH by JAMA is a place to begin. China’s ‘3+1+13’ perioperative remedy mannequin has the very best evidence-based medical worth and can set up new remedy requirements for sufferers, bringing transformative modifications to the prognosis and remedy panorama of lung most cancers in China and past,” mentioned NEOTORCH’s principal investigator, Dr. Shun LU of the Shanghai Chest Hospital inside Shanghai Jiaotong College.

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As a part 3 scientific research of perioperative remedy, NEOTORCH enrolled the most important pattern of resectable stage III NSCLC sufferers in China. Of the 501 randomized sufferers, 404 stage III NSCLC (202 within the toripalimab + chemotherapy group and 202 within the placebo + chemotherapy group) have been included on this interim evaluation. Sufferers have been randomized in a 1:1 ratio to obtain toripalimab or placebo, as soon as each 3 weeks mixed with platinum-based chemotherapy for 3 cycles earlier than and 1 cycle after surgical procedure, adopted by toripalimab solely or placebo for as much as 13 cycles.

As of November 30, 2022 (median follow-up of 18.3 months), outcomes confirmed that the addition of toripalimab to perioperative chemotherapy led to a major enchancment in event-free survival for sufferers with resectable stage III NSCLC, and this remedy technique had a manageable security profile.

For the first end result of event-free survival (assessed by investigator), the median size was not estimable within the toripalimab group in contrast with 15.1 months within the placebo group (hazard ratio, 0.40 [95%CI, 0.28-0.57], P&LT0.001). The main pathological response charge (one other major end result assessed by blinded, unbiased pathological assessment) was 48.5% within the toripalimab group in contrast with 8.4% within the placebo group. The pathological full response charge (secondary end result assessed by blinded, unbiased pathological assessment) was 24.8% within the toripalimab group in contrast with 1.0% within the placebo group.

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Of the 82.2%(166/202) of sufferers within the toripalimab group and 73.3% (148/202) of sufferers within the placebo group who underwent surgical procedure, 95.8percentand 92.6%, respectively, had their resections labeled as R0. Among the many sufferers who underwent surgical procedure, the median size 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&LT0.001). The median size of total survival was not estimable within the toripalimab group in contrast with 30.4 months within the placebo group (HR, 0.62 [95% CI, 0.38-1.00]).

“NEOTORCH’s important analysis findings have been revealed by JAMA, underscoring the worldwide educational group’s recognition of toripalimab and the world’s first ‘3+1+13’ perioperative immunotherapy mannequin for lung most cancers. We anticipate that toripalimab will information China’s perioperative lung most cancers remedy into a brand new period. Junshi Biosciences may even proceed to innovate, and we goal to convey extra superior and improved remedy choices to sufferers,” mentioned Dr. Jianjun ZOU, Normal Supervisor and Chief Government Officer of Junshi Biosciences.

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About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its capability to dam PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis perform). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s capability to assault and kill tumor cells.

Greater than forty company-sponsored toripalimab scientific research protecting greater than fifteen indications have been carried out globally by Junshi Biosciences, together with in China, the US, Southeast Asia, and Europe. Ongoing or accomplished pivotal scientific trials evaluating the protection and efficacy of toripalimab cowl a broad vary of tumor sorts, together with cancers of the lung, nasopharynx, esophagus, abdomen, bladder, breast, liver, kidney, and pores and skin.

In China, toripalimab was the primary home anti-PD-1 monoclonal antibody accepted for advertising and marketing (accepted in China as TUOYI®). At present, there are seven accepted indications for toripalimab in China:

1. unresectable or metastatic melanoma after failure of ordinary systemic remedy;
2. recurrent or metastatic nasopharyngeal carcinoma (“NPC”) after failure of a minimum of two strains of prior systemic remedy;
3. regionally superior or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed inside 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
4. together with cisplatin and gemcitabine because the first-line remedy for sufferers with regionally recurrent or metastatic NPC;
5. together with paclitaxel and cisplatin in first-line remedy of sufferers with unresectable regionally superior/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
6. together with pemetrexed and platinum because the first-line remedy in EGFR mutation-negative and ALK mutation-negative, unresectable, regionally superior or metastatic non-squamous non-small cell lung most cancers (NSCLC);
7. together with chemotherapy as perioperative remedy and subsequently with monotherapy as adjuvant remedy for the remedy of grownup sufferers with resectable stage IIIA-IIIB NSCLC.

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The primary six indications have been included within the Nationwide Reimbursement Drug Record (NRDL) (2023 Version). Toripalimab is the one anti-PD-1 monoclonal antibody included within the NRDL for the remedy of melanoma.

In the US, the U.S. Meals and Drug Administration (FDA) has accepted the Biologics License Software for toripalimab together with cisplatin and gemcitabine for the first-line remedy of adults with metastatic or recurrent regionally superior NPC, and for toripalimab, as a single agent, for the remedy of adults with recurrent, unresectable, or metastatic NPC with illness development on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Remedy designations for the remedy of NPC, 1 Quick Monitor designation for the remedy of mucosal melanoma, and 5 Orphan Drug designations for the remedy of esophageal most cancers, NPC, mucosal melanoma, gentle tissue sarcoma, and small cell lung most cancers (SCLC).

In Europe, advertising and marketing authorization purposes (MAA) have been accepted by the European Medicines Company (EMA) and the UK’s Medicines and Healthcare merchandise Regulatory Company (MHRA) for 1) toripalimab mixed with cisplatin and gemcitabine for the first-line remedy of sufferers with regionally recurrent or metastatic NPC and a couple of) toripalimab mixed with paclitaxel and cisplatin for the first-line remedy of sufferers with unresectable regionally superior/recurrent or metastatic ESCC, in December 2022 and February 2023.

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In Australia, the brand new chemical entity (NCE) software was accepted by the Australia Therapeutic Items Administration (TGA) in November 2023. The TGA has additionally granted toripalimab an Orphan Drug designation for the remedy of NPC.

About Junshi Biosciences

Based in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical firm devoted to the invention, growth and commercialization of progressive therapeutics. The corporate has established a diversified R&D pipeline comprising over 50 drug candidates, with 5 therapeutic focus areas protecting most cancers, autoimmune, metabolic, neurological, and infectious ailments. 4 of the corporate’s improvements have already reached the Chinese language or worldwide markets, one among which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, accepted in China and the US. Moreover, greater than 30 medicine are presently in scientific growth. In the course of the COVID-19 pandemic, Junshi Biosciences actively shouldered the social obligations of a Chinese language pharmaceutical firm by means of its involvement in growing etesevimab, MINDEWEI®, and different novel therapies for the prevention and remedy of COVID-19.

With a mission of “offering sufferers with world-class, reliable, reasonably priced, and progressive medicine”, Junshi Biosciences is “In China, For World.” At current, the corporate boasts roughly 3,000 workers in the US (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, and many others). For extra data, please go to: http://junshipharma.com.

Junshi Biosciences Contact Data
IR Group:
Junshi Biosciences
data@junshipharma.com
+ 86 021-6105 8800

PR Group:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

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