Toripalimab Plus Chemotherapy Meets PFS End Point in PD-L1+ TNBC

Toripalimab plus nab-paclitaxel (albumin-bound paclitaxel injection; Abraxane) demonstrated a significant improvement in progression-free survival (PFS) compared with placebo and nab-paclitaxel in PD-L1–positive patients with stage IV or recurrent/metastatic triple-negative breast cancer (TNBC), according to topline findings from an interim analysis of the phase 3 TORCHLIGHT trial (NCT04085276).¹

Additionally, investigators reported a positive trend toward improved overall survival (OS)—a key secondary end point—with the combination, irrespective of PD-L1 status. The safety profile of toripalimab was consistent with its known profile, and no new signals were reported.

Per Junshi Biosciences, the developer of toripalimab, TORCHLIGHT is the first phase 3 registrational study in China to demonstrate a positive outcome with immunotherapy in advanced TNBC. The company also announced it will discuss the parameters regarding the supplemental new drug application with the regulatory authorities in the near future.

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

Checkpoint inhibitors have led to significant improvements in the treatment of several tumors. However, immunotherapy has not been approved for use in patients with advanced TNBC in China, leaving chemotherapy, which is associated with median survival of approximately 9 to 12 months and a 5-year survival rate of less than 30%, as the current standard of care.

TORCHLIGHT is a randomized, double-blind, placebo-controlled, multi-center phase 3 trial evaluating the safety and efficacy of toripalimab plus nab-paclitaxel compared with placebo plus nab-paclitaxel in patients with stage IV or recurrent/metastatic TNBC.

To be eligible for enrollment, patients could not have received more than 1 line of chemotherapy in the metastatic setting and had to be eligible for taxane monotherapy. Traditional criteria included an ECOG performance status of 0 or 1, at least 1 measurable lesion per RECIST v1.1 criteria, adequate hematologic and organ function, and life expectancy of at least 12 weeks.²

Prior treatment with taxane as frontline therapy or exposure to another checkpoint inhibitor precluded patients from enrollment.

The primary end point was PFS in the intention-to-treat and PD-L1–positive population per blinded independent central review using RECIST v1.1 criteria. In addition to OS, other secondary end points included objective response rate, duration of response, disease control rate, and safety and tolerability.

“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,” Dr Jianjun Zou, president of Global Research and Development at Junshi Biosciences, said. “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 21, 2023. https://www.junshipharma.com/en/
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 21, 2023. https://clinicaltrials.gov/ct2/show/NCT04085276