Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced an additional indication approval for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), from China’s National Medical Products Administration (NMPA). The drug is now approved for use as perioperative treatment in combination with chemotherapy for resectable stage IIIA-IIIB non-small cell lung cancer (NSCLC), followed by toripalimab alone as adjuvant therapy.
The approval is supported by the results of the NEOTORCH study, a randomized, double-blind, placebo-controlled, multi-center Phase III study led by Shanghai Chest Hospital and conducted across 56 centers in China. This study, the world’s first Phase III study for a PD-1 inhibitor as NSCLC perioperative treatment with positive event-free survival (EFS) data, enrolled 404 stage IIIA-IIIB NSCLC patients. Patients were randomized to receive toripalimab/chemotherapy versus placebo/chemotherapy for three cycles before surgery and one cycle after surgery, followed by 13 cycles of adjuvant therapy with toripalimab or placebo.
The data indicates that the combination of toripalimab and chemotherapy as perioperative treatment for resectable stage III NSCLC significantly prolonged patient EFS compared to chemotherapy alone (median EFS not yet reached vs 15.1 months, P<0.001), reducing the risk of disease recurrence, progression, or death by 60% (HR=0.40, 95% CI: 0.277-0.565). EFS benefits were observed across all key subgroups in the toripalimab group, regardless of PD-L1 expression status and histological type (squamous or non-squamous).
Toripalimab, China’s first domestic PD-1 inhibitor approved in December 2018 as a second-line treatment for melanoma, has received six indication approvals in China to date. The drug, which is subject to over 40 clinical studies in more than 15 indications globally, was approved for two nasopharyngeal carcinoma (NPC) indications in the United States in October last year.- Flcube.com
