Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combination as First-Line Therapy for Biliary Tract Tumors, Compared to Durvalumab

HONG KONG, Nov. 1, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the successful enrollment of the first patient in the HARMONi-GI-01/AK112-309 study, a randomized, controlled, multicenter Phase III registration study for biliary track tumor. This trial is designed to compare the ivonescimab combined regimen, a PD-1/VEGF bispecific antibody internally developed by Akeso, with the durvalumab (PD-L1) combined regimen for the first-line treatment of advanced biliary tract cancers (BTC). The primary endpoint of the AK112-309 study is overall survival (OS).

This study represents the sixth registrational Phase III clinical trial featuring ivonescimab, with a PD-1/L1 monoclonal antibody as the comparator. It underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights Akeso's capability to maximize the number of cancer patients globally that can benefit from its product portfolio through a strategic approach to clinical development.

Previously, the positive results from a Phase II clinical study of ivonescimab in combination with chemotherapy for the first-line treatment of BTC were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings demonstrated that the ivonescimab regimen exhibits significant antitumor activity and a good safety profile in BTC.

• The objective response rate (ORR), as assessed by investigators, was 63.6%, with an ORR of 77.8% specifically for patients with gallbladder cancer. The disease control rate (DCR) reached 100%.
• The median progression-free survival (PFS) was 8.5 months, with a 6-month PFS rate of 84.4%.
• Furthermore, the median overall survival (OS) was 16.8 months, with a 9-month OS rate of 81.8%. Notably, patients with gallbladder cancer exhibited a median OS of 16.8 months.

At the time of the analysis, the median follow-up time was 13.8 months. The study included patients with a median age of 65.3 years, of whom 81.8% had an ECOG performance status of 1. All enrolled patients are presented with unresectable tumors, and 40.9% were diagnosed with gallbladder cancer.

Biliary tract malignancies, originating from the bile ducts and gallbladder, represent a group of highly heterogeneous cancers associated with a poor prognosis. At the time of diagnosis, approximately 50% of biliary tract cancer patients are already in advanced stages, often with a survival period of less than one year. Although PD-1/L1 inhibitors in combination with chemotherapy have been approved as a first-line treatment for advanced biliary tract cancer, the overall survival benefit has been limited, particularly for patients with gallbladder cancer. The initial positive clinical data from the ivonescimab regimen indicates a possible advancement in the therapeutic landscape for these challenging malignancies.

About Ivonescimab (AK112/SMT112)

Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

source: Akeso, Inc.