First-Line Toripalimab Plus Chemo Wins Approval in China for Advanced TNBC

China’s National Medical Products Administration (NMPA) has approved toripalimab-tpzi (Loqtorzi) in combination with nab-paclitaxel (Abraxane) for the first-line treatment of patients with recurrent or metastatic triple-negative breast cancer (TNBC).¹

The regulatory decision was supported by data from the phase 3 TORCHLIGHT trial (NCT04085276), which demonstrated that the addition of toripalimab to nab-paclitaxel led to a statistically significant improvement in progression-free survival (PFS) in the PD-L1–positive population vs paclitaxel plus placebo (HR, 0.65; 95% CI, 0.470-0.906; P = .0102). In this population, the median PFS was 8.4 months in the toripalimab arm (n = 200) vs 5.6 months for those in the placebo arm (n = 100).²

Additionally, the toripalimab regimen led to a 38% reduction in the risk of death compared with chemotherapy alone the PD-L1–positive population (HR, 0.62; 95% CI, 0.414-0.914; P = .0148). Patients treated in the experimental arm experienced a median overall survival (OS) of 32.8 months compared with 19.5 months for those in the control arm.

“Immunotherapy has become the most important treatment for TNBC,” principal investigator Zefei Jiang, MD, of the Department of Oncology of the Chinese People’s Liberation Army General Hospital, stated in a news release.¹ “The TORCHLIGHT study introduces immune checkpoint inhibitors in addition to traditional chemotherapy, which not only significantly prolongs the median PFS for patients with advanced TNBC, but also demonstrates notable benefits to OS, increasing the total survival time for [patients with] TNBC to more than 30 months. As the very first approved immunotherapy for TNBC in China, toripalimab will set a new standard for the first-line treatment of TNBC.”

TORCHLIGHT was a multicenter, randomized, double-blind trial that enrolled patients with histologically confirmed TNBC who were eligible for taxane monotherapy and received no more than 1 line of chemotherapy in the metastatic setting. Other key inclusion criteria included an ECOG performance status of 0 or 1; a life expectancy of at least 12 weeks; at least 1 measurable lesion per RECIST 1.1 criteria; and adequate hematologic and organ function.³

Key exclusion criteria consisted of prior treatment with a PD-1, PD-L1, PD-L2, or CTLA-4 antibody; confirmed active or untreated brain metastases; and meningeal carcinomatosis.

Patients were randomly assigned to receive toripalimab at 240 mg once every 3 weeks plus nab-paclitaxel at 125 mg/m2 on days 1 and 8 of every 3-week cycle (n = 353); or placebo once every 3 weeks plus the same nab-paclitaxel regimen (n = 178).^2,3

PFS as assessed by blinded independent central review in the intention-to-treat and PD-L1–positive populations served as the trial’s primary end points. Secondary end points included investigator-assessed PFS, objective response rate, duration of response, disease control rate, OS, and safety.

Regarding safety, the rates of any-grade treatment-emergent adverse effects (TEAEs) were 99.2% in the toripalimab arm and 98.9% in the placebo arm. The rates of grade 3 or higher TEAEs were 56.4% and 54.3%, respectively. Fatal AEs occurred in 0.6% of patients in the toripalimab arm vs 3.4% of patients in the placebo arm.

“For a long time, effective treatments for advanced TNBC have been lacking,” Jianjun Zou, MD, PhD, general manager and chief executive officer of Junshi Biosciences, stated in a news release. “The approval of this new indication is another milestone success, and it offers new hope to Chinese patients with advanced TNBC. As of now, toripalimab has 10 approved indications in China. Moving forward, we will remain dedicated to patient care, collaborate with Chinese experts and scholars, and address the long-standing unmet clinical needs of many more patients.”

References

1. Junshi Biosciences announces approval of the sNDA for toripalimab for the 1st-line treatment of advanced TNBC. News release. Junshi Biosciences. June 25, 2024. Accessed June 25, 2024. https://www.globenewswire.com/news-release/2024/06/25/2903696/0/en/Junshi-Biosciences-Announces-Approval-of-the-sNDA-for-Toripalimab-for-the-1st-Line-Treatment-of-Advanced-TNBC.html
2. Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2024;30(1):249-256. doi:10.1038/s41591-023-02677-x
3. 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 March 7, 2023. Accessed June 25, 2024. https://clinicaltrials.gov/study/NCT04085276