SHANGHAI, China, January 9, 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.
According to the prespecified descriptive analysis of OS, a trend toward improved OS favoring toripalimab was observed in the PD-L1-positive population, with median OS at 32.8 versus 19.5 months (HR = 0.62, 95% CI 0.414–0.914, nominal P = 0.0148). The 1, 2 and 3-year OS rates in the PD-L1-positive population were 82.6% versus 73.0%, 64.6% versus 43.5% and 47.9% versus 33.0% in the two arms, respectively. Similar OS improvement was also observed in the ITT population favoring toripalimab, with median OS 33.1 versus 23.5 months (HR = 0.69, 95% CI 0.513–0.932, nominal P = 0.0145). The 1, 2 and 3-year OS rates in the ITT population were 81.0% versus 77.6%, 61.0% versus 47.2% and 48.4% versus 32.1% in the two arms, respectively.
Patients in the toripalimab arm had a significantly longer DoR than those in the control arm in the PD-L1-positive subgroup and ITT populations. The median DoR was 10.8 versus 5.6 months (HR = 0.55, 95% CI 0.366–0.830, nominal P = 0.0040) in the PD-L1-positive subgroup; and 8.5 versus 6.9 months (HR 0.64, 95% CI 0.468–0.881, nominal P = 0.0060) in the ITT population.
Similar incidences of treatment-emergent adverse events (AEs) (99.2% versus 98.9%), grade ≥3 treatment-emergent AEs (56.4% versus 54.3%) and fatal AEs (0.6% versus 3.4%) occurred in the toripalimab and control arms.
In May 2023, the supplemental new drug application (sNDA) for toripalimab in combination with albumin-bound paclitaxel for the treatment of PD-L1 positive (CPS ≥ 1) previously-untreated metastatic or recurrent metastatic TNBC was accepted by the National Medical Products Administration (NMPA).
“I am delighted to see the TORCHLIGHT study reach new heights once again,” said Dr. Jianjun ZOU, Global Research and Development President of Junshi Biosciences. “TORCHLIGHT’s series of successes would not have been possible without the collaboration and determination of the patients, researchers, and R&D team. The groundbreaking outcomes of this study has the potential to address unmet clinical needs and offer Chinese TNBC patients better treatment options.”