ASCO 2023: Toripalimab Combination Therapy – A Breakthrough for TNBC

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ASCO 2023: Junshi Biosciences Unveils Breakthrough Phase III Trial Results: Toripalimab Combination Therapy Shows Remarkable Efficacy in Metastatic or Recurrent TNBC


Combining taxanes-based chemotherapy with checkpoint blockade yields diverse outcomes in the first-line metastatic triple-negative breast cancer (TNBC) treatment. Toripalimab, a humanized IgG4K monoclonal antibody targeting PD-1, has shown significant clinical efficacy and a favorable safety profile in various solid tumors. The results presented at the ASCO 2023 conference, as of the data cutoff date of November 30, 2022, included 531 randomized patients with PD-L1 positive TNBC who received toripalimab. 

Based on the interim analysis with a median follow-up of 14 months, the group receiving toripalimab exhibited a statistically significant improvement in progression-free survival (PFS), as supported by the Blinded Independent Central Review (BICR) results. Additionally, the subgroup of patients with PD-L1 positive tumors showed promising advancements, with an extended median PFS of 8.4 months compared to 5.6 months.

Moreover, a descriptive analysis revealed a positive trend in overall survival (OS) for PD-L1-positive patients, with a notable increase in median OS from 19.5 months to 32.8 months. Safety results indicated that no new safety signals were identified. However, the rates of Grade≥3 adverse events (AEs) and fatal AEs were comparable between the treatment arms (56.4% vs. 54.3% and 0.6% vs. 3.4%, respectively). Notably, the toripalimab arm showed a higher frequency of AEs leading to treatment discontinuation (8.5% vs. 3.4%) and immune-related AEs (irAEs) (40.8% vs. 24.0%).

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