Akeso's Ivonescimab Phase III Overall Survival Data in First-Line Biliary Tract Cancer Selected for ESMO 2026 Presidential Symposium
核心洞察
Akeso reported positive overall survival results from the Phase III HARMONi-GI1 trial of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy in first-line advanced biliary tract cancer (搜索).
The HARMONi-GI1 data were selected as a Late-Breaking Abstract for the Presidential Symposium at the 2026 ESMO Congress in Madrid, October 23 to 27.
Nearly 30 Akeso studies of its bispecific antibodies will be presented at ESMO 2026, including 12 for ivonescimab and 15 for cadonilimab across more than ten tumor types.
Akeso, Inc. announced that positive overall survival results from the Phase III HARMONi-GI1 trial of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer (搜索) have been selected as a Late-Breaking Abstract for the Presidential Symposium at the 2026 European Society for Medical Oncology (ESMO) Congress. The meeting runs October 23 to 27 in Madrid, Spain, and the HARMONi-GI1 data will be delivered as a late-breaking oral presentation.
HARMONi-GI1 is described as a randomized, controlled, double-blinded Phase 3 trial. The presentation, listed as LBA8, is scheduled for Presidential Symposium II on Sunday, October 25, 2026, from 16:30 to 18:15 Madrid time in the Alicante Auditorium, Hall 6. Jian Zhou of Shanghai, China, is listed as the speaker.
Ivonescimab Across Solid Tumors
Ivonescimab, which Akeso describes as the world's first approved PD-1 (搜索)/VEGF (搜索) bispecific antibody, will be featured in 12 presentations at ESMO 2026. Beyond biliary tract cancer (搜索), two rapid oral presentations will report data on ivonescimab-based regimens as first-line treatment for advanced renal cell carcinoma (搜索) and recurrent or metastatic thymic carcinoma (搜索).
The renal cell carcinoma presentation covers AK112 (ivonescimab) as first-line treatment for patients with IMDC favorable-risk advanced renal cell carcinoma (搜索), with results from a Phase Ib/II study. It is scheduled as abstract 3592RO in Rapid Oral 2, covering genitourinary tumors, renal and urothelial, on Sunday, October 25, 2026, from 14:45 to 16:15 Madrid time. Xieqiao Yan of Peking University Cancer Hospital is the presenter.
The thymic carcinoma (搜索) presentation reports interim results from the iTHYM study of ivonescimab plus chemotherapy as first-line treatment in recurrent or metastatic thymic carcinoma. It is listed as abstract 4156RO in a rapid oral session on non-metastatic NSCLC and other thoracic malignancies, scheduled for Monday, October 26, 2026, from 10:15 to 11:45 Madrid time. Xue Hou of Sun Yat-sen University Cancer Center is the presenter.
Akeso said the ESMO presentations will also highlight ivonescimab's expanding development across multiple tumor types, including continued progress in lung cancer, including brain metastases, gastrointestinal cancers such as esophageal and gastric cancer, and rare or difficult-to-treat malignancies including pancreatic cancer, glioblastoma, endometrial cancer, thymic carcinoma (搜索), and head and neck squamous cell carcinoma.
Cadonilimab Data Span More Than Ten Tumor Types
Cadonilimab, which Akeso describes as the world's first PD-1 (搜索)/CTLA-4 (搜索) bispecific antibody, will be featured in 15 presentations covering more than ten tumor types. These include 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. The studies span neoadjuvant settings as well as first- and second-line treatment of advanced disease.
Pipeline and Platform Context
Akeso, founded in 2012, states that it has built an R&D ecosystem anchored by its Tetrabody antibody technology platform, an AI-powered drug R&D platform, the Dual-Shield ADC technology platform, the Dual-Lock T-cell engager technology platform, a Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms.
The company reports a pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Nearly 30 candidates have advanced into clinical trials, including 15 bispecific or multi-specific antibodies and bispecific ADCs. Eight innovative drugs are commercially available, and two additional drugs with three indications are under regulatory review for marketing approval.
Akeso said full results from the ESMO 2026 presentations will be released during the Congress.