Akeso to Present Data from 13 Clinical Studies at ESMO 2024 on I/O Antibodies Including Cadonilimab

HONG KONG, Sept. 5, 2024 -- Akeso, Inc. (9926.HK) has announced compelling outcomes from 13 clinical trials focusing on its innovative therapies, which include the PD-1/CTLA-4 bispecific antibody cadonilimab, the PD-1/VEGF bispecific antibody ivonescimab, the next-generation CD47 monoclonal antibody ligufalimab, and the commercially available PD-1 monoclonal antibody penpulimab. These findings will be presented at the ESMO Congress 2024, taking place from September 13th to 17th (CEST). The clinical studies cover a range of advanced cancers such as colorectal cancer, triple-negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), nasopharyngeal carcinoma, gynecological cancers, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies.

A highlight of the event will be the first-time presentation of clinical results for ivonescimab in combination with ligufalimab. The Mini Oral Session will feature data on ivonescimab, with or without ligufalimab, plus chemotherapy for metastatic colorectal cancer (mCRC) and ivonescimab combined with chemotherapy for TNBC. Additionally, a Phase III study comparing anlotinib combined with penpulimab versus sorafenib for HCC will be presented as a late-breaking abstract in the Proffered Paper Session.

Key findings from these presentations include:

Colorectal Cancer:
The study titled "The efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI as first-line (1L) treatment for metastatic colorectal cancer (mCRC)" reveals that ivonescimab offers significant benefits in objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS) for MSS-type mCRC patients, outperforming standard treatments. Combining ivonescimab with ligufalimab further enhances clinical outcomes. The Mini Oral Session will be presented by Yanhong Deng from Sun Yat-sen University Sixth Affiliated Hospital on September 14.

Triple-Negative Breast Cancer:
The study "The safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC)" reports strong ORR and DCR, along with significant PFS results. These findings are particularly notable given the high proportion of PD-L1 negative patients and those previously treated with taxane-based therapies. The Mini Oral Session will be led by Xiaojia Wang from Zhejiang Provincial Cancer Hospital on September 16.

Head And Neck Squamous Cell Carcinoma:
The study "Evaluation of the safety and efficacy of ivonescimab in combination with ligufalimab as first-line treatment for PD-L1 positive recurrent/metastasis head and neck squamous cell carcinoma (R/M HNSCC)" shows that ivonescimab significantly improves ORR and PFS, especially when combined with ligufalimab, compared to existing PD-1 treatments. The results indicate a notable improvement in patient outcomes, with a Phase III trial against Keytruda set to begin enrollment in late 2024. This will be presented in a Poster Session on September 14.

Hepatocellular Carcinoma:
Initial results from the Phase III ALTN-AK105-III-02 study "Anlotinib plus penpulimab versus sorafenib as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC)" will be presented in a Proffered Paper Session on September 13.

Gynecological Oncology:
Several studies will be presented, including "A phase II study of cadonilimab plus chemotherapy in persistent recurrent/metastatic cervical cancer patients who failed previous immuno/chemotherapy," "Real-world efficacy and safety of cadonilimab in recurrent or metastatic cervical cancer," and "Cadonilimab with neoadjuvant chemotherapy in advanced ovarian cancer patients." These findings will be showcased in Poster Sessions on September 14.

Nasopharyngeal Carcinoma:
The study "Combination of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) with chemotherapy in anti-PD-1 resistant recurrent or metastatic nasopharyngeal carcinoma" will be presented on September 14.

Biliary Tract Cancer:
The study "Cadonilimab in combination with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX)" will be discussed on September 16.

Gastric Cancer:
Two studies titled "Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer" and "Neoadjuvant SOX combined with cadonilimab (AK104) for PD-L1 negative upper GC/GEJC patients" will be presented on September 16.

Esophageal Squamous Cell Carcinoma:
The study "Efficacy and safety of cadonilimab combined with albumin-paclitaxel, cisplatin, and fluorouracil (APF) in neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma (LAESCC)" will also be featured on September 16.

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