Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment of recurrent or metastatic triple negative breast cancer (TNBC) with positive PD-L1 (CPS ≥ 1) as determined by fully validated tests.
The approval follows the successful results of the TORCHLIGHT study, which met its pre-set superiority threshold for the primary endpoint in an interim analysis conducted in February 2023. This study stands as the first regulatory Phase III study for immunotherapy in advanced TNBC to report positive results. In the study, the median progression-free survival (PFS) in the toripalimab group was 8.4 months, with a 35% reduction in the risk of disease progression or death (P=0.0102). Additionally, the median overall survival (OS) in the toripalimab group was extended to 13.3 months, with a 38% reduction in the risk of death (P=0.0148). The safety profile of toripalimab remains consistent with known risks, and no new safety signals were identified.
Toripalimab, China’s first domestically approved PD-1 inhibitor, was initially approved in December 2018 as a second-line treatment for melanoma. It has since received a total of nine indication approvals in China. The drug also has six indications that are reimbursed under the National Reimbursement Drug List (NRDL).- Flcube.com
