Ivonescimab HARMONi-6 Results Selected for ESMO 2025 LBA; Final Phase III Results of Cadonilimab as First-Line Therapy for Advanced Gastric Cancer to Be Published as an Oral Presentation

HONG KONG, Sept. 22, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) is excited to announce that the Late-Breaking Abstract (LBA) from the registrational Phase III clinical study (AK112-306/HARMONi-6 study) of ivonescimab, a globally first-in-class bispecific antibody targeting PD-1 and VEGF, will be presented at the 2025 European Society for Medical Oncology (ESMO) Annual Congress. This study, which evaluates ivonescimab in combination with chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC), has been selected for the Presidential Symposium. The study's principal investigator, Professor Lu Shun, Director of the Department of Oncology at Shanghai Chest Hospital, will present the results from this pivotal study.

Additionally, the final results of the Phase III clinical study (COMPASSION-15/AK104-302 study) of cadonilimab in combination with oxaliplatin and capecitabine as first-line treatment for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, have been accepted for a Mini Oral Session at ESMO. Cadonilimab is a first-in-class bispecific antibody targeting PD-1 and CTLA-4 developed by Akeso that is currently approved for first line treatment of gastric cancer, first line treatment of cervical cancer, and second/third line treatment of cervical cancer. The study's principal investigator, Professor Shen Lin from Peking University Cancer Hospital, will present the findings in an oral presentation.

Phase Ⅲ Study of lvonescimab plus chemotherapy versus Tislelizumab plus chemotherapy as Firstline Treatment for advanced squamous non-small cell lung cancer (HARMONi-6)

• Speakers: Professor Shun Lu (Shanghai, China)
• Session: Presidential Symposium 2 Proffered Paper session
• Presentation Time: 16:30 -16:42 (CEST) Sun. 19.10.2025
• Room: Berlin Auditorium - Hub 27

The upcoming detailed results from the HARMONi-6 study, to be presented at ESMO 2025, will provide a comprehensive overview of the exceptional efficacy and favorable safety profile of ivonescimab in combination with chemotherapy for the treatment of first line advanced squamous NSCLC. These findings will further underscore ivonescimab's role in advancing treatment strategies beyond first-generation immuno-oncology therapies.

The HARMONi-6 study represents the third Phase III trial of ivonescimab in NSCLC, showing significant positive outcomes. This trial is particularly important as it introduces an antiangiogenic mechanism-based therapy for sq-NSCLC, a subtype previously lacking such therapeutic options. Notably, it is the second Phase III head-to-head trial where ivonescimab has outperformed a PD-1 inhibitor-based regimen, reinforcing its breakthrough clinical value.

The promising results thus far affirm that ivonescimab provides significant advancements in clinical treatment for NSCLC, whether compared to PD-1 monotherapy, PD-1 plus chemotherapy, or VEGF-targeted therapies. The consistent superiority observed in these comparisons highlights ivonescimab's potential to redefine treatment paradigms in oncology.

In April 2025, Akeso announced that the topline results from the registrational Phase III study, HARMONi-6, met its primary endpoint of progression-free survival (PFS), as confirmed by the Independent Data Monitoring Committee (IDMC). The results showed statistically significant and clinically meaningful improvements in PFS for ivonescimab plus chemotherapy compared to tislelizumab plus chemotherapy. In the intent-to-treat (ITT) population, patients receiving ivonescimab plus chemotherapy showed significantly superior PFS benefits compared to the control group. This PFS improvement was consistently observed across all subgroups, regardless of PD-L1 expression status.

On July 28, 2025, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) accepted the supplemental New Drug Application (sNDA) for ivonescimab in combination with chemotherapy as a first-line treatment for advanced sq-NSCLC.

• Speaker: Professor Shen Lin, Peking University Cancer Hospital
• Presentation Format: Mini Oral Session
• Abstract Number: 2098MO
• Presentation Time: 10:45–10:50 AM (CEST) , Saturday, 18 October 2025

The final results of the COMPASSION-15 study, to be presented at ESMO 2025, will further validate the groundbreaking clinical value of the cadonilimab-based regimen, reinforcing its potential as a transformative therapeutic option for advanced gastric cancer.

Preliminary findings from the COMPASSION-15 study were first presented by Professor Ji Jiafu of Peking University Cancer Hospital at the 2024 American Association for Cancer Research (AACR) Annual Meeting. These results garnered international recognition and were subsequently published in the esteemed Nature Medicine journal. Due to the positive clinical results, cadonilimab received approval from the NMPA in September 2024 for the first-line treatment of advanced gastric cancer. Furthermore, the regimen was included as the only immunotherapy strategy with a Category I Recommendation (Level IA Evidence) in the 2025 CSCO Gastric Cancer Guidelines, facilitating its widespread adoption in clinical practice.

Forward-Looking Statement of Akeso, Inc.

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.

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, 24 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.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

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