On September 22, 2025 Akeso Inc. (9926.HK) reported 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) (Free ESMO Whitepaper) Annual Congress (Press release, Akeso Biopharma, SEP 22, 2025, View Source [SID1234656155]). 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.
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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 (Free ESMO Whitepaper). 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 (Free ESMO Whitepaper) 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.
Cadonilimab (Cado) plus chemotherapy (chemo) versus chemotherapy as first-line (1L) treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: final results of the Phase Ⅲ COMPASSION-15 trial
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 (Free ESMO Whitepaper) 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) (Free AACR Whitepaper) 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.