SHANGHAI, China, January 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.