Shanghai Junshi Biosciences has completed the pre-specified interim analysis for the Phase III TORCHLIGHT clinical trial of toripalimab along with paclitaxel for injection (albumin-bound) in advanced triple-negative breast cancer patients.

The multi-centre, double-blind, randomised, placebo-controlled Phase III trial compares the efficacy and safety of the combination of toripalimab and paclitaxel for injection (albumin-bound) against a placebo, along with paclitaxel, for injection in people with stage IV breast cancer or an initial recurrent/metastatic triple-negative breast cancer diagnosis.

Its interim analysis showed that the combination of toripalimab and paclitaxel for injection can significantly prolong the progression-free survival (PFS) of PD-L1 positive patients.

Additionally, the overall survival (OS) was also found to be improved in PD-1 positive patients and in all patients, irrespective of the PD-1 status.

The TORCHLIGHT study is claimed to be the first Phase III registration trial to achieve a positive outcome in an advanced triple-negative breast cancer immunotherapy trial in China.

The Independent Data Monitoring Committee (IDMC) has ascertained that the primary endpoint of the trial met the pre-defined efficacy requirement.

Chinese People’s Liberation Army General Hospital Department of Oncology professor Zefei JIANG said: “Advanced TNBC patients have limited survival rates and lack effective treatment methods.

“These results demonstrate that the combined use of the monoclonal antibody, toripalimab, with traditional chemotherapy significantly prolonged the PFS of patients, and this has the potential to become a new standard treatment for patients with an initial diagnosis of stage IV TNBC, as well as those with recurrent/metastatic TNBC, offering patients new hope!”

The company intends to communicate with the regulatory authorities soon regarding the supplemental new drug application of toripalimab.

Junshi Biosciences Global Research and Development president Dr. Jianjun ZOU said: “We will work closely with regulatory authorities to ensure that relevant indications are approved as soon as possible.”