Akeso Begins Patient Enrollment in Phase 3 Trial of Ivonescimab Combination

Akeso Begins Patient Enrollment in Phase 3 Trial of Ivonescimab Combination

By, Admin 5 November 2024

Akeso begins patient enrollment in phase 3 trial of ivonescimab combination as first-line therapy for biliary tract tumours, compared to durvalumab

Overview

Akeso Biopharma, a leading biopharmaceutical company, announced 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 tumour. 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).

About the Study

  • 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.

Results Presentation at ASCO

  • 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.

Objective Response Rate

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%.
 
PFS: - The median progression-free survival (PFS) was 8.5 months, with a 6-month PFS rate of 84.4%.

Overall Survival (OS)

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 tumours, and 40.9% were diagnosed with gallbladder cancer.

Biliary Tract Malignancies

  • 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 the Immunotherapy Drug: Ivonescimab

  • 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 the Company: Akeso

  • Akeso 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.