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 - Seite 2

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.