The phase III clinical study of Junshi Biologics in combination with teripulimab in the treatment of advanced triple-negative breast cancer reached the primary endpoint

Recently, Junshi Biotechnology (1877. HK,688180 .SH) announces that the randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (TORCHLIGHT study) of the first stage IV or recurrent metastatic triple-negative breast cancer (TNBC) in combination with paclitaxel (albumin-binding type) developed by the Company has completed the protocol-pre-programmed midterm analysis of the anti-PD-1 monoclonal antibody drug teripulimab combined with paclitaxel (albumin-binding type) for the treatment of first-diagnosed stage IV or relapsed metastatic triple-negative breast cancer (TNBC). Junshi Biologics will communicate with the regulatory authorities in the near future to submit the marketing application for this new indication.

According to statistics, the annual number of new cases of breast cancer and the number of deaths in the world reach 226.68 million [1], which is the highest incidence of cancer in the world. In China, the annual number of new cases of breast cancer and the number of deaths reached 42,12, accounting for 18.4% and 17.1% of the global cases, respectively [2]. Triple-negative breast cancer (TNBC) accounts for about 15-20% of all breast cancers and is characterized by high aggressiveness, high recurrence rate, and poor prognosis [3],[4]. Advanced TNBC is insensitive to targeted therapy and endocrine therapy, and lacks specific treatments.

In recent years, tumor immunotherapy drugs represented by PD-(L)1 inhibitors have made a series of breakthroughs in many tumor types. However, at present, there is no approved immunotherapy drug for advanced TNBC in China, and the treatment is still mainly chemotherapy, and the drugs available include anthracyclines, taxane, platinum drugs, etc. However, the efficacy of both single and combined chemotherapy is not good, the median survival is about 9~12 months, and the 5-year survival rate is less than 30% [4], [5].

The TORCHLIGHT study (NCT04085276) is the first phase III registration study in China to achieve positive results in the field of advanced TNBC immunotherapy. This randomized, double-blind, placebo-controlled, multicenter phase III clinical study aims to compare the efficacy and safety of teripulimab plus paclitaxel (albumin-binding type) with placebo plus paclitaxel (albumin-binding type) in patients with first-time diagnosis or relapsed metastatic TNBC.

According to the results of this interim analysis, teripulimab combined with paclitaxel for injection (albumin-binding type) in patients with stage IV or recurrent metastatic TNBC at first diagnosis significantly prolongs progression-free survival (PFS) in PD-L1-positive people compared with paclitaxel for injection (albumin-binding type), while overall survival (OS), a secondary endpoint for the whole population and PD-L1-positive population, also showed a clear trend of benefit. The safety data for teripulimab were consistent with known risks, and no new safety signals were identified. Regarding the detailed research data, Junshi Biologics will be presented at the upcoming international academic conference.

Professor Jiang Zefei, principal investigator of the TORCHLIGHT study, Vice President and Secretary-General of the Chinese Society of Clinical Oncology (CSCO), and Department of Oncology, PLA General Hospital, said:

"TNBC is the most aggressive and prognostic subtype of breast cancer, and advanced patients lack effective treatment and have extremely limited survival rates. In order to change the survival situation of patients, TORCHLIGHT, the first phase III study led by Chinese scholars for tumor immunotherapy in patients with advanced TNBC, was successfully carried out, especially after withstanding the challenges of the new crown epidemic in the past three years, and finally achieved exciting breakthrough results. The results showed that the combination of teripulimab on the basis of traditional chemotherapy could significantly prolong the PFS of patients, which is expected to become a new standard for the treatment of stage IV and recurrent metastatic TNBC at the first diagnosis, bringing new hope to patients. ”

Dr. Jianjun Zou, President of Global R&D of Junshi Biologics, said:

"WE ARE DELIGHTED THAT THE TORCHLIGHT STUDY HAS BEEN SUCCESSFUL, THANKS TO THE JOINT EFFORTS AND DEDICATION OF PATIENTS, INVESTIGATORS AND THE R&D TEAM. We will actively communicate with the regulatory authorities to advance the marketing application of relevant indications as soon as possible. We hope that teripulimab can enable patients with advanced TNBC in China to obtain better treatment options and solve unmet clinical needs. ”