Akeso, Inc. announced that ivonescimab, its global first-in-class bispecific antibody targeting PD-1 and VEGF, has been granted its fifth Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This latest designation applies to ivonescimab in combination with chemotherapy for the first-line treatment of advanced biliary tract cancer (BTC). This milestone represents the fifth BTD awarded to ivonescimab by the NMPA, following three prior designations in lung cancer indications and one for triple-negative breast cancer (TNBC).
The repeated recognition highlights ivonescimab's broad clinical potential across multiple high unmet need tumor types. A randomized, controlled, multicenter, registrational Phase III clinical study (AK112-309/HARMONi-GI1) is evaluating ivonescimab plus chemotherapy versus durvalumab (a PD-L1 inhibitor) plus chemotherapy for first-line treatment of advanced BTC. Patient enrollment has been completed, and the BTD status for this indication underscores the promising clinical profile of ivonescimab.
The BTD status is expected to accelerate both the ongoing clinical development and the regulatory review process in China. Encouraging results from a Phase 1b/II study, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual meeting, support the potential of the ivonescimab combination therapy as a superior first-line treatment for advanced BTC. In the study,ivonescimab plus chemotherapy achieved an Objective Response Rate (ORR) of 63.6% and a Disease Control Rate (DCR) of 100%.
The ivonescimab regimen also demonstrated a median Progression-Free Survival (mPFS) of 8.5 months and a median Overall Survival (mOS) of 16.8 months. These compelling Phase II results provide a robust foundation for the ongoing Phase III registrational trial and reinforce ivonescimab's potential to address the significant unmet needs in advanced BTC, where current treatment options often yield limited durable responses. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso.
There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. R risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
