Junshi Biosciences Announces Approval of the Supplemental New Drug Application for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients - Seite 2

A total of 404 patients with stage IIIA-IIIB NSCLC were enrolled in the study and randomized at a ratio of 1:1 to receive toripalimab in combination with chemotherapy (n=202) or placebo in combination with chemotherapy (n=202). The patients received three cycles of pre-operative treatment and one cycle of post-operative treatment with toripalimab or placebo in combination with chemotherapy (paclitaxel in combination with cisplatin for patients with squamous NSCLC, while pemetrexed in combination with cisplatin for patients with non-squamous NSCLC), respectively; they then received either toripalimab or placebo for 13 cycles of adjuvant therapy.

The latest study results of the NEOTORCH study were announced in an oral presentation at the 2023 American Society of Clinical Oncology (“ASCO”) Plenary Series held in April, as well as the 2023 ASCO annual meeting. The study data showed that compared to chemotherapy alone, toripalimab in combination with chemotherapy for perioperative treatment of resectable stage III NSCLC could significantly extend patient EFS (median EFS as assessed by investigators: not reached vs. 15.1 months, P < 0.0001), and reduce the risk of disease recurrence, progression, or death in patients by 60% (HR=0.40, 95% CI: 0.277-0.565), and EFS benefits was observed in all key toripalimab subgroups, regardless of PD-L1 expression status and histologic type (squamous or non-squamous). Major pathological remission (MPR) rates and pathological complete remission (pCR) rates were significantly better in the toripalimab group, 48.5% vs 8.4% (P < 0.0001) and 24.8% vs 1.0% (P < 0.0001), respectively, and the overall survival (OS) of the toripalimab group also showed a clear trend of benefit. In terms of safety, the incidences of treatment-emergent adverse events (TEAEs) were similar in both groups, and no new safety signals were observed.

“The NEOTORCH study has pioneered the world’s first ‘3+1+13’ perioperative treatment model for NSCLC, which has resulted in nearly 25 times higher rates of pCR and 6 times higher rates of MPR compared to patients treated with chemotherapy alone,” said, Professor Shun LU of Shanghai Chest Hospital of the Shanghai Jiao Tong University School of Medicine. “Additionally, this model has achieved elevated rates of R0 resection without increasing the surgical risks. Post-surgery, this regimen requires one cycle of immunotherapy combined with chemotherapy, along with a year-long maintenance treatment with toripalimab, which further eliminates patients’ residual lesions and extends benefits to those who did not achieve pCR. The EFS hazard ratio (HR) of 0.40 stands as the most substantial reduction in HR reported in perioperative immunotherapy studies to date. We believe that the approval of China’s first perioperative immunotherapy indication for lung cancer will significantly impact the long-term survival prospects for stage III NSCLC patients in China, opening up new avenues for potential treatments, drastically improving the standard of NSCLC treatment in China, and setting a new benchmark for perioperative treatment.”