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Updated Efficacy Data of Ivonescimab Combined with Chemotherapy as First-Line Treatment for TNBC Presented at ESMO IO 2025

Ivonescimab plus chemotherapy showed an 80% objective response rate and 100% disease control rate in first-line treatment for advanced triple-negative breast cancer, with no treatment-related deaths.

  • Yesterday, Akeso, Inc. presented updated Phase II data on ivonescimab at the ESMO Immuno‑Oncology Congress, London, UK, noting the regimen is on China's CDE/NMPA Breakthrough Therapy Designation list.
  • The Phase II clinical study extended follow-up to 22.1 months with 36 patients enrolled and 35 patients in efficacy analysis set as of July 15, 2025.
  • Efficacy metrics included ORR 80.0% and DCR 100%, with mDOR 12.2 months and mPFS 15.2 months, across all PD‑L1 subgroups.
  • Investigators reported mostly grade 1–2 TRAEs with no TRAE‑related discontinuations or deaths, supporting ivonescimab combined with chemotherapy's favorable safety profile.
  • A randomized Phase III HARMONi‑BC1/AK112‑308 trial is ongoing; overall survival data are not yet mature, and Akeso issues forward‑looking statements and risk disclosures.
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Updated Efficacy Data of Ivonescimab Combined with Chemotherapy as First-Line Treatment for TNBC Presented at ESMO IO 2025

HONG KONG, Dec. 10, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the presentation of a Phase II clinical study that included a longer-term efficacy data evaluating ivonescimab (a PD-1/VEGF bispecific antibody) combined with chemotherapy as a…

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PR Newswire broke the news in United States on Thursday, December 11, 2025.
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