Junshi Biosciences Announces Publication of Results from TORCHLIGHT, a Randomized Phase 3 Trial of Toripalimab for the Treatment of Metastatic or Recurrent Triple-negative Breast Cancer in Nature Medicine

SHANGHAI, China, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced the publication of results from TORCHLIGHT (NCT04085276), a randomized, double-blind, placebo-controlled phase 3 study comparing the efficacy and safety of toripalimab versus placebo, in combination with nab-paclitaxel for patients with newly diagnosed metastatic or recurrent locally advanced triple-negative breast cancer (TNBC) in Nature Medicine.

TORCHLIGHT is the first registered Phase 3 study to achieve positive results in advanced TNBC immunotherapy in China. It was jointly conducted across 56 centers nationwide, with principal investigator Professor Zefei JIANG from the Department of Oncology of the Chinese People’s Liberation Army General Hospital and Vice President and Secretary General of the Chinese Society of Clinical Oncology (CSCO).

“Using immunotherapy with Chinese products and designs to address the challenges of Chinese patients with advanced TNBC, TORCHLIGHT has produced encouraging results, providing some TNBC patients with an opportunity at prolonged survival,” said Professor Zefei JIANG.

From December 25, 2018, to November 30, 2022, 531 patients were enrolled and randomized at a 2:1 ratio into either the experimental arm (n = 353; treated with toripalimab and nab-paclitaxel) or the control arm (n = 178; treated with placebo and nab-paclitaxel). A total of 300 patients had PD-L1-positive TNBC: 200 in the toripalimab arm and 100 in the control arm. The primary endpoints were progression-free survival (PFS), as assessed by blinded independent central review (BICR) per RECIST v.1.1, in the PD-L1-positive subgroup and the intention-to-treat (ITT) population. The secondary endpoints included overall survival (OS) in the PD-L1-positive and ITT populations, 1-year and 2-year OS rates, PFS as assessed by the investigator, objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and safety.

TORCHLIGHT’s results show that the addition of toripalimab to nab-paclitaxel significantly improved PFS for PD-L1-positive patients with metastatic or recurrent TNBC, while maintaining an acceptable safety profile.

At the prespecified interim analysis (cutoff date of 30 November 2022), a statistically significant improvement in PFS assessed by BICR was demonstrated in the toripalimab arm in the PD-L1-positive population (median PFS 8.4 versus 5.6 months; hazard ratio (HR) = 0.65, 95% confidence interval (CI) 0.470–0.906, P = 0.0102), which had crossed the prespecified efficacy boundary of 0.0273. The 1-year PFS rate was 41.9% versus 24.4%, and the 2-year PFS rate was 23.5% versus 14.5%. The interim analysis of PFS in the ITT population showed a similar improvement in BICR-assessed PFS. The median PFS was 8.4 and 6.9 months for the toripalimab and control arms, respectively, and the HR was 0.77 (95% CI 0.602–0.994), P = 0.0445.