Ivonescimab First-Line Biliary Tract Cancer Phase III Overall Survival Data Selected as ESMO Late-Breaking Abstract; Nearly 30 Akeso Studies to Be Presented at ESMO 2026

On September 21, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that nearly 30 clinical studies of its globally first-in-class bispecific antibodies will be presented at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place October 23–27 in Madrid, Spain. The presentations include one Late-Breaking Abstract (LBA) selected for the Presidential Symposium and two oral presentations.

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Ivonescimab, the world’s first approved PD-1/VEGF bispecific antibody, will be featured in 12 presentations at ESMO (Free ESMO Whitepaper) 2026. Notably, positive overall survival results from the Phase III HARMONi-GI1 trial evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer have been selected as a Late-Breaking Abstract for the Presidential Symposium and will be delivered as a late-breaking oral presentation. In addition, two rapid oral presentations will present breakthrough data on ivonescimab-based regimens as first-line treatment for advanced renal cell carcinoma and recurrent/metastatic thymic carcinoma. The presentations will also highlight ivonescimab’s expanding development across multiple tumor types, including continued progress in lung cancer (including brain metastases), gastrointestinal cancers (esophageal and gastric cancer), and rare or difficult-to-treat malignancies such as pancreatic cancer, glioblastoma, endometrial cancer, thymic carcinoma, and head and neck squamous cell carcinoma.

Cadonilimab, the world’s first PD-1/CTLA-4 bispecific antibody, will be featured in 15 presentations covering more than ten tumor types, including gastric cancer, renal cell carcinoma, lung cancer, esophageal squamous cell carcinoma, colorectal cancer, nasopharyngeal carcinoma, ovarian cancer, soft tissue sarcoma, pleural mesothelioma, and rectal cancer. These studies span neoadjuvant settings as well as first- and second-line treatment of advanced disease, underscoring the broad anti-tumor potential of this dual checkpoint inhibitor.

The extensive data to be presented at ESMO (Free ESMO Whitepaper) 2026 reflect Akeso’s ongoing commitment to advancing next-generation immuno-oncology therapies for major global diseases and our continued efforts to build a differentiated global oncology portfolio. Full results will be released during the Congress. Please stay tuned for updates.

Key Presentations Highlights:

LBA8 – Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double- blinded, Phase 3 trial (HARMONi-GI1)

Speakers: Jian Zhou (Shanghai, China)
Session Name: Presidential Symposium II
Room: Alicante Auditorium – Hall 6
Date: Sunday, 25 October 2026
Time: 16:30 – 18:15 (Madrid)
Efficacy and Safety of AK112 (Ivonescimab), a PD-1/VEGF Bispecific Antibody, as First-Line Treatment for Patients with IMDC Favorable-Risk Advanced Renal Cell Carcinoma (aRCC): Results from a Phase Ib/II Study

Session: Rapid Oral 2: Genitourinary tumours, renal and urothelial
Abstract: 3592RO
Presentation time: Sunday, 25 October 2026, 14:45–16:15 (Madrid)
Presenter: Professor Xieqiao Yan, Peking University Cancer Hospital
Ivonescimab plus chemotherapy as first-line treatment in recurrent/metastatic thymic carcinoma: interim results from the iTHYM study

Session: Rapid Oral: Non-metastatic NSCLC and other thoracic malignancies
Abstract: 4156RO
Presentation time: Monday, 26 October 2026, 10:15–11:45 (Madrid)
Presenter: Professor Xue Hou, Sun Yat-sen University Cancer Center

(Press release, Akeso Biopharma, SEP 21, 2026, View Source [SID1234670978])