Shanghai Junshi Biosciences Co., Ltd. announced that a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“Neotorch”, NCT04158440) of the company's anti-PD-1 monoclonal antibody, toripalimab, in combination with platinum-containing doublet chemotherapy as perioperative treatment for operable non-small cell lung cancer (“NSCLC”) patients, has finished the pre-specified interim analysis. The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of event-free survival (“EFS”) has met the pre-defined efficacy boundary. Junshi Biosciences will communicate with regulatory authorities regarding matters related to the supplemental New Drug Application in the near future.

Lung cancer is currently the second most prevalent type of cancer with the highest mortality rate in the world. According to data released by the World Health Organization, in 2020, the number of new lung cancer cases in China amounted to 816,000 and accounted for 17.9% of all new cancer cases in China. In the same year, the number of lung cancer deaths in China amounted to 715,000 and accounted for 23.8% of all cancer deaths in China.

NSCLC is a major subtype of lung cancer, accounting for approximately 85% of all cases. Amongst these patients, 20%-25% are surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of such patients will suffer from post-surgical recurrence and death. Radical surgery in combination with chemotherapy is a way to prevent recurrence, but chemotherapy, as preoperative neoadjuvant or postoperative adjuvant therapy, has limited clinical benefit and can only raise the 5-year survival rate of patients by approximately 5%.

Immuno-oncology (I-O) therapy, a type of treatment best represented by PD-(L)1 inhibitors, can provide patients with long-term tumor control or elimination. By relieving the immune suppression of immune cells caused by cancer cells, PD-(L)1 inihibitors reactivate the patients' own immune system to destroy cancer. At present, the global community has accumulated sufficient clinical evidence proving that I-O can significantly improve the overall survival of patients with advanced NSCLC.

However, the research on patients with operable NSCLC began relatively recently and focused solely on preoperative neoadjuvant or postoperative adjuvant I-O therapy. Perioperative I-O therapy covering the whole process, including pre- and post-surgery, is expected to be a better treatment model for patients. Neotorch is the world's first phase III registered study of perioperative I-O therapy for lung cancer with a positive EFS result.

Led by Professor Shun LU of Shanghai Chest Hospital as primary researcher, the study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study aiming to compare the efficacy and safety of toripalimab in combination with platinum-containing doublet chemotherapy versus placebo in combination with platinum-containing doublet chemotherapy for patients with operable NSCLC. The primary endpoints are EFS as assessed by researchers and major pathological remission rate (“MPR rate”) as assessed by the Blind Independent Pathology Review Committee (“BIPR”). The secondary endpoints include pathological complete remission rate (pCR rate) as assessed by BIPR and researchers, EFS as assessed by Independent Review Committee (“IRC”), and disease free survival (DFS), overall survival (OS) and safety as assessed by IRC and researchers, etc.

The study was launched in 56 centers nationwide. Patients with operable NSCLC received toripalimab/placebo in combination with platinum-containing doublet chemotherapy as neoadjuvant and adjuvant therapy, and received toripalimab monotherapy as consolidation therapy after postoperative adjuvant therapy. Platinum-containing doublet chemotherapy was selected by researchers according to treatment practices of therapeutic institutions, of which paclitaxel in combination with cisplatin was for patients with squamous NSCLC, while pemetrexed in combination with cisplatin was for non-squamous NSCLC.

Based on the interim analysis, compared with chemotherapy alone, toripalimab in combination with chemotherapy as perioperative treatment for phase III operable NSCLC patients and toripalimab monotherapy for consolidation therapy thereafter may significantly extend EFS of patients. The safety data of toripalimab is in line with known risks, with no new safety signals identified.