Akeso, Inc. is set to present data from 13 clinical studies at the ESMO Congress 2024, showcasing its internally developed bispecific antibodies and other immuno-oncology (IO) antibodies across a range of advanced cancers. The presentations will feature data on cadonilimab (PD-1/CTLA-4 bispecific antibody), ivonescimab (PD-1/VEGF bispecific antibody), ligufalimab (next-generation CD47 monoclonal antibody), and penpulimab (PD-1 monoclonal antibody).
The studies cover advanced colorectal cancer (mCRC), triple-negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies.
Ivonescimab in Metastatic Colorectal Cancer
Ivonescimab's clinical results, both alone and in combination with ligufalimab, will be presented for the first time. The data highlights the efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI as a first-line treatment for metastatic colorectal cancer (mCRC). Previous immunotherapies have shown limited benefits in first-line treatment of MSS-type mCRC. Ivonescimab has demonstrated meaningfully significant ORR, DCR, and PFS in these mCRC patients. When combined with ligufalimab (CD47), the clinical outcome improved further, surpassing current standard treatments. Yanhong Deng from Sun Yat-sen University Sixth Affiliated Hospital will present these findings in a Mini Oral Session.
Ivonescimab in Triple-Negative Breast Cancer
Data on ivonescimab combined with chemotherapy for TNBC will also be featured in a Mini Oral Session. The study evaluated the safety and efficacy of ivonescimab in combination with chemotherapy as a first-line treatment for triple-negative breast cancer (TNBC). Notably, a significant proportion of patients were PD-L1 negative (53.3%), and 60% had previously received taxane-based neoadjuvant therapy. Ivonescimab demonstrated robust ORR and DCR. PFS results were meaningfully significant, even in patients with limited follow-up time and immature data. The safety profile of ivonescimab aligns with results from prior studies. Xiaojia Wang from Zhejiang Provincial Cancer Hospital will present these findings.
Ivonescimab and Ligufalimab in Head and Neck Squamous Cell Carcinoma
Preliminary data suggests that ivonescimab improves ORR and PFS for patients needing rapid tumor shrinkage in PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Ivonescimab combined with ligufalimab (CD47) further extends both ORR and PFS. Ivonescimab, both as monotherapy and in combination with ligufalimab, has yielded preliminary results that significantly outperform currently approved PD-1 treatments. A Phase III head-to-head trial against Keytruda is scheduled to initiate patient enrollment in the fourth quarter of 2024.
Penpulimab in Hepatocellular Carcinoma
The Phase III study of anlotinib combined with penpulimab versus sorafenib for HCC will be presented as a late-breaking abstract in the Proffered Paper Session. This study evaluates the primary results from the phase III ALTN-AK105-III-02 study, comparing anlotinib plus penpulimab versus sorafenib as first-line therapy for advanced hepatocellular carcinoma (aHCC).
Cadonilimab Across Multiple Cancers
Additional presentations will cover cadonilimab in various settings, 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: a multicenter retrospective analysis in China.
- Cadonilimab with neoadjuvant chemotherapy in advanced ovarian cancer patients: an open, prospective, single arm, phase II trial.
- Combination of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) with chemotherapy in anti-PD-1 resistant recurrent or metastatic nasopharyngeal carcinoma: an open-label, single-arm, phase II clinical trial.
- Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A Phase II, single-arm clinical trial.
- Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer: A prospective, single-arm, phase II clinical trial.
- Neoadjuvant SOX combined with cadonilimab (AK104) for PD-L1 negative upper GC/GEJC patients.
- Efficacy and safety of cadonilimab combined albumin-paclitaxel, cisplatin and fluorouracil (APF) in neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma (LAESCC): results from the CAPITAL trial.
