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 - Seite 2

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.”

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.