Toripalimab Plus Chemotherapy Lengthens PFS in Chinese Metastatic/Recurrent TNBC Population

The combination of toripalimab (Tuoyi) and nab-paclitaxel prolonged progression-free survival (PFS) in Chinese patients with stage IV breast cancer or recurrent/metastatic triple-negative breast cancer (TNBC), meeting the primary end point of the phase 3 TORCHLIGHT clinical trial (NCT04085276).¹

According to an Independent Data Monitoring Committee (IDMC) review, the PFS benefit of toripalimab plus nab-paclitaxel was shown in the PD-L1-positive population. In addition, there was a trend toward overall survival (OS) improvement, regardless of PD-L1 status. The safety of toripalimab in the study appears consistent with the known risks. No new safety signals have been shown.

“The TNBC subtype of breast cancer is the most aggressive and has the worst prognosis,” said professor Zefei Jiang, MD, from the Department of Oncology at the Chinese People’s Liberation Army General Hospital, the vice president and secretary general of the Chinese Society of Clinical Oncology (CSCO), and principal investigator of the TORCHLIGHT study, in a press release.

“[Patients with] advanced TNBC have limited survival rates and lack effective treatment methods. Aiming to improve patient survival, a group of Chinese researchers successfully conducted the first phase 3 study on immune-oncology for [patients with] advanced TNBC, even amidst the COVID-19 pandemic, and achieved breakthrough results. 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,” Jiang added.

TORCHLIGHT is a randomized, double-blind, multicenter, in which toripalimab and nab-paclitaxel was compared with nab-paclitaxel alone in 561 patients with metastatic or recurrent TNBC with or without systemic treatment. In terms of the study end point, PFS is being assessed per blinded independent committee review in the overall population and PD-L1-positive population. The secondary end points of the study include investigator-assessed PFS, objective response rate, duration of response, disease control rate, OS, 12-month OS rate, 24-month OS rate, differences in safety and tolerability, and differences in the scores of disease/treatment-related symptoms.²

The TORCHLIGHT study is actively recruiting patients in China who are 18 years of age or older, have histologically a confirmed diagnosis of Metastatic or recurrent TNBC, who are eligible to receive taxane monotherapy, and those who have had 1 or fewer lines of chemotherapy prior to the study. Patients are also required to have an ECOG performance status of 0 to 2, a life expectancy of at least 12 weeks, a minimum of 1 measurable lesion per RECIST v1.1, and adequate hematologic and organ function.

Toripalimab is not an FDA-regulated drug. However, toripalimab has been granted orphan drug designations for the treatment of small cell lung cancer and esophageal cancer. The agent has also been granted fast track designation for the treatment of mucosal melanoma, and a biologics license application has been filed for toripalimab plus chemotherapy for the treatment of advanced recurrent or metastatic nasopharyngeal carcinoma.¹

“I’m extremely pleased that TORCHLIGHT research has been successful, and its success is a result of the dedicated efforts of patients, researchers, and development teams,” said Jianjun Zou, MD, the president of Global Research and Development at Junshi Biosciences, in the press release. “We will work closely with regulatory authorities to ensure that relevant indications are approved as soon as possible. We hope that toripalimab will provide better treatment options for patients and address unmet medical needs.”

_REFERENCES:

_{1. Junshi Biosciences announces toripalimab in combination with chemotherapy for treatment of advanced triple-negative breast cancer met primary endpoint in phase 3 clinical study. News release. Junshi Biosciences. February 20, 2023. Accessed February 22, 2023. https://bit.ly/3Stq86o}

_{2. Toripalimab in combination with nab-paclitaxel for patients with metastatic or recurrent triple-negative breast cancer (TNBC) with or without systemic treatment (TORCHLIGHT). ClinicalTrials.gov. Updated September 15, 2022. Accessed February 22, 2023. https://clinicaltrials.gov/ct2/show/NCT04085276?term=TORCHLIGHT&draw=2&rank=1}