Over 40 Studies Featuring Akeso's Innovative Oncology Agents to Be Presented at ASCO 2026: Ivonescimab's HARMONi-6 Overall Survival Data Selected for Plenary Session

HONG KONG, May 26, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that more than 40 clinical studies of its oncology portfolio will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2 in Chicago, Illinois. Notably, the presentations include one Late-Breaking Abstract (LBA) selected for the prestigious Plenary Session, alongside four Oral or Rapid Oral presentations.

The datasets featured at ASCO 2026 primarily highlight the Company's core first-in-class bispecific antibodies — cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF) — along with other novel therapeutic antibodies such as ligufalimab, a next-generation CD47 monoclonal antibody. These presentations include several potentially practice-changing datasets across multiple tumor types.

A pivotal highlight will be the Phase III overall survival (OS) results from the HARMONi-6 study, evaluating the survival advantage of ivonescimab combined with chemotherapy versus a PD-1 inhibitor combined with chemotherapy in the first-line setting for advanced squamous non-small cell lung cancer (sq-NSCLC). Additional notable presentations feature ivonescimab in small-cell lung cancer (SCLC) that has progressed after first-line chemoimmunotherapy, ivonescimab plus chemotherapy in first-line metastatic colorectal cancer (mCRC) from a global Phase II interim analysis, alongside cadonilimab-based regimens in renal cell carcinoma, melanoma, colorectal cancer, head and neck cancer, gynecologic malignancies, and biliary tract cancer.

The maturity and breadth of these datasets underscore the success of Akeso's innovation engine, demonstrating the clinical benefits of the Company's differentiated bispecific antibody platform to the international oncology community.

Key Presentations

Plenary Session

Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in previously untreated advanced squamous non-small cell lung cancer: Overall survival results of the Phase 3 HARMONi-6 study

• Abstract: LBA4
• Session: Plenary Session
• Date/Time (CDT): May 31, 2026, 2:47 PM–2:59 PM
• Presenter: Professor Shun Lu, Shanghai Chest Hospital

Oral Presentation

Efficacy and safety of ivonescimab combined with liposomal irinotecan in patients with small-cell lung cancer (SCLC) progressing after first-line chemoimmunotherapy: A multicenter, Phase 2 study

• Abstract: 8007
• Date: June 2, 2026
• Presenter: Professor Yun Fan, Zhejiang Cancer Hospital

Oral Presentation

A prospective, multicenter, Phase Ib/II trial of first-line cadonilimab plus axitinib in advanced non–clear cell renal cell carcinoma

• Abstract: 4501
• Date: June 2, 2026
• Presenter: Dr. Junru Chen, West China Hospital, Sichuan University

Rapid Oral Presentation

Neoadjuvant ivonescimab (AK112, a PD-1/VEGF bispecific antibody) combined with nab-paclitaxel and cisplatin for resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC): An exploratory Phase II study

• Abstract: 6014
• Date: June 2, 2026
• Presenter: Professor Kunyu Yang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Rapid Oral Presentation

Cadonilimab or ivonescimab plus axitinib in metastatic mucosal melanoma: Results from a Phase Ib trial

• Abstract: 9516
• Date: May 31, 2026
• Presenter: Professor Lili Mao, Peking University Cancer Hospital

International Multicenter Phase II Study

Ivonescimab (ivo) with oxaliplatin + fluorouracil (5-FU) + leucovorin calcium (mFOLFOX6) for patients (pts) with unresectable metastatic colorectal cancer (mCRC): A phase II study

• Abstract: 3576
• Date: May 30, 2026
• First Author: David Berz, MD, PhD,  Department of Oncology, Valkyrie Clinical Trials, Inc

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 established a robust R&D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical 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, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. 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.

Forward-Looking Statements
This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

SOURCE Akeso, Inc.