Promising Advances in TNBC Treatment with Ivonescimab
Akeso, Inc. (9926.HK) recently presented a groundbreaking Phase II clinical study at the European Society for Medical Oncology Immuno-Oncology Congress, demonstrating the long-term efficacy of ivonescimab combined with chemotherapy as a first-line treatment for triple-negative breast cancer (TNBC). This innovative therapy targets patients dealing with locally advanced unresectable or metastatic TNBC, marking a significant advancement in treatment options.
The results highlighted at this major oncology event clarify the efficacy and safety profile of ivonescimab, a PD-1/VEGF bispecific antibody. The Center for Drug Evaluation had previously recognized this combination therapy, listing it in its Breakthrough Therapy Designation as a promising treatment option. Currently, Akeso is conducting a multicenter, randomized, double-blind Phase III trial (HARMONi-BC1/AK112-308), aiming to further identify the potential of this combination.
Insights from the Phase II Clinical Study
The extended follow-up period for participants in the clinical study reached an impressive 22.1 months. As of the latest analysis, 36 patients diagnosed with TNBC were enrolled, with an average age of 55 years. Notably, around 83.3% of these patients had a PD-L1 combined positive score (CPS) of less than 10, indicating a diverse range of involvement in the study.
The efficacy analysis focused on 35 patients who underwent at least one post-baseline tumor assessment. Results indicated a remarkable performance from the ivonescimab regimen; patients experienced notable tumor relief and disease control. The objective response rate (ORR) stood at 80%, while the disease control rate (DCR) peaked at 100%. Furthermore, the median duration of response (mDOR) was recorded at 12.2 months, and the median progression-free survival (mPFS) plateaued at 15.2 months.
Subgroup Analysis for Efficacy
The study also broke down the results into specific subgroups based on CPS scores:
- For the CPS?10 subgroup, the ORR was an impressive 83.3%, maintaining a DCR of 100% and a corresponding mPFS of 15.9 months.
- The CPS<10 subgroup displayed an ORR of 79.3%, with a consistent DCR of 100% and an mPFS interval of 13.04 months.
- For patients with a CPS?1, the results indicated a 72.2% ORR, with the same DCR of 100%, and an mPFS of 15.9 months.
Safety Profile and Future Considerations
Importantly, the ivonescimab therapy showcased a commendable safety profile. According to the study, no treatment-related adverse events (TRAEs) resulted in patient discontinuation or fatalities. The primary TRAEs recorded were largely grade 1-2, portraying a manageable safety landscape for patients.
While the overall survival (OS) data remains immature, the findings provide a significant basis for continuing development and research into the ivonescimab regimen for TNBC treatment. Akeso is earnestly pursuing the next phases of research to not only validate these promising results but also to shape the future landscape of TNBC therapies.
About Akeso
Founded in 2012, Akeso (HKEX: 9926.HK) has established itself as a leading biopharmaceutical company, dedicated to developing innovative biological medicines that aim to be the first or best-in-class in their respective areas. With a unique integrated research and development innovation system, Akeso aims to provide accessible therapeutic solutions across various diseases, including cancer and autoimmune conditions.
Utilizing a comprehensive platform, Akeso is actively cultivating a robust pipeline of over 50 innovative assets, with 26 candidates reaching clinical trial stages, demonstrating their commitment to advancing healthcare through groundbreaking therapies.
Frequently Asked Questions
What is ivonescimab?
Ivonescimab is a PD-1/VEGF bispecific antibody being developed for the treatment of various cancers, particularly TNBC.
What were the key findings of the recent study on ivonescimab?
The study reported an 80% objective response rate and a 100% disease control rate, indicating significant efficacy for TNBC patients.
How many patients were involved in the Phase II study?
A total of 36 patients diagnosed with TNBC participated in the trial.
What is the safety profile of ivonescimab?
The safety profile is encouraging, with no severe adverse events leading to treatment discontinuation or death.
What is the next step for Akeso following these findings?
Akeso is continuing its research through a Phase III clinical trial to further validate the efficacy and safety of ivonescimab.
