Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced significant progress in the Phase III TORCHLIGHT study for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The study, which combines Tuoyi with paclitaxel and albumin, has completed its pre-set interim analysis for initially-diagnosed stage IV or recurrent metastatic triple-negative breast cancer (TNBC). The Independent Data Monitoring Committee (IDMC) has determined that the study’s endpoint has reached the pre-set superiority threshold, paving the way for further regulatory discussions.
Study Design and Results
The randomized, double-blind, placebo-controlled, multi-center Phase III study was designed to compare the safety and efficacy of the toripalimab/paclitaxel combination against placebo/paclitaxel in patients with initially-diagnosed stage IV or recurrent metastatic TNBC. The results showed that the toripalimab/paclitaxel combination significantly prolonged the progression-free survival (PFS) of PD-L1 positive patients with initially-diagnosed stage IV or recurrent metastatic TNBC. Additionally, the secondary endpoint of overall survival (OS) for the entire population and PD-L1-positive patients also demonstrated a significant trend of benefit. The safety profile was consistent with known risks, and no new safety signals were identified.
Regulatory Milestones and Market Access
Toripalimab was the first domestic PD-1 inhibitor to be approved in China in December 2018 for the second-line treatment of melanoma. Since then, it has received multiple regulatory approvals, including as a second-line treatment for nasopharyngeal carcinoma (NPC) in February 2021, for locally advanced or metastatic urothelial cancer (UC) in previously treated patients in April 2021, as a first-line treatment for NPC in November 2021, and as a first-line treatment for esophageal squamous cell carcinoma (ESCC) in May 2022. The molecule was included on the National Reimbursement Drug List (NRDL) for three indications last year, making it the only PD-1 inhibitor to treat melanoma and NPC on the list. The US FDA previously granted Breakthrough Therapy Designation status to toripalimab plus chemotherapy for first-line NPC and for toripalimab as a monotherapy for second or third-line treatment of recurrent or metastatic NPC. Junshi first filed for approval of toripalimab plus chemotherapy for first-line NPC in the US in November 2021 and received a Complete Response Letter in May 2022. A Biologic License Application (BLA) was refiled in July of the previous year with a PDUFA date of December 2022. However, the regulatory decision has been indefinitely delayed due to COVID-19 disruptions in China.-Fineline Info & Tech
