Akeso to Present Data from 13 Clinical Studies at ESMO 2024, Featuring its Internally Developed Cadonilimab, Ivonescimab, Ligufalimab, and other I/O Antibodies

HONG KONG, Sept. 6, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) will showcase promising results from 13 clinical studies on its internally developed PD-1/CTLA-4 bispecific antibody cadonilimab, PD-1/VEGF bispecific antibody ivonescimab, next-generation CD47 monoclonal antibody ligufalimab, and commercially available PD-1 monoclonal antibody penpulimab at the ESMO Congress 2024 from September 13th to 17^th (CEST). These studies span advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies.

Notably, ivonescimab's clinical results in combination with ligufalimab will be presented for the first time. Data on ivonescimab ± ligufalimab plus chemotherapy for mCRC and ivonescimab combined with chemotherapy for TNBC will be featured in the Mini Oral Session. Additionally, 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. Stay tuned for additional updates!

Details of the Presentations:

Colorectal Cancer
Abstract Title: The efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI as first-line (1L) treatment for metastatic colorectal cancer (mCRC)

Key Study Findings:
For first-line treatment of MSS-type mCRC, previous immunotherapies have shown limited benefits. Ivonescimab has achieved meaningfully significant ORR, DCR, and PFS (although data is immature) in these mCRC patients. When combined with ligufalimab (CD47), the clinical outcome improved further, surpassing current standard treatments. These findings highlight the promising potential of ivonescimab, both alone and in combination with ligufalimab, for treating MSS-type mCRC.

• Session Type: Mini Oral Session
• Number: 514MO
• Presentation Presentation Time: Saturday, 14 September 15:50-15:55 (CEST)
• Speaker: Yanhong Deng, Sun Yat-sen University Sixth Affiliated Hospital

Triple-Negative Breast Cancer
Abstract Title: The safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC)

Key Study Findings:
Most patients were PD-L1 negative (53.3%). The proportion of patients who had previously received taxane-based neoadjuvant therapy (60%) was higher than in similar targeted drug studies. 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.

• Session Type: Mini Oral Session
• Number: 347MO
• Presentation Time: Monday, 16 September 08:30-08:35 (CEST)
• Speaker: Xiaojia Wang, Zhejiang Provincial Cancer Hospital

Head And Neck Squamous Cell Carcinoma
Abstract Title: 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)

Key Study Findings:
PD-1 is the standard first-line treatment for CPS≥1 R/M HNSCC but has limited efficacy. Preliminary data from this study suggest that ivonescimab improves ORR and PFS for patients needing rapid tumor shrinkage. 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.

• Session Type: Poster Session
• Number: 876P
• Presentation Time: Saturday, 14 September 2024 (CEST)

Abstract Title: Neoadjuvant and Adjuvant AK104 in patients with recurrent, resectable squamous cell carcinoma of the head and neck: A phase II study

• Session Type: Poster Session
• Number: 866P
• Presentation Time: Saturday, 14 September 2024 (CEST)

Hepatocellular Carcinoma
Abstract Title: Primary 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)

• Session Type: Proffered Paper Session
• Number: LBA40
• Presentation Time: Friday,13 September 16:55-17:05 (CEST)

Gynecological Oncology
Abstract Title: A phase II study of cadonilimab plus chemotherapy in persistent recurrent/ metastatic cervical cancer patients who failed previous immuno/chemotherapy

• Session Type: Poster Session
• Number: 732P
• Presentation Time: Saturday, 14 September 2024 (CEST)

Abstract Title: Real-world efficacy and safety of cadonilimab in recurrent or metastatic cervical cancer: a multicenter retrospective analysis in China

• Session Type: Poster Session
• Number: 727P
• Presentation Time: Saturday, 14 September 2024 (CEST)

Abstract Title: Cadonilimab with neoadjuvant chemotherapy in advanced ovarian cancer patients : an open, prospective, single arm, phase II trial

• Session Type: Poster Session
• Number: 760P
• Presentation Time: Saturday, 14 September 2024(CEST)

Nasopharyngeal Carcinoma
Abstract Title: 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

• Session Type: Poster Session
• Number: 893P
• Presentation Time: Saturday, 14 September 2024(CEST)

Biliary Tract Cancer
Abstract Title: Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A Phase II, single-arm clinical trial

• Session Type: Poster Session
• Number: 52P
• Presentation Time: Monday, 16 September 2024 (CEST)

Gastric Cancer
Abstract Title: Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer: A prospective, single-arm, phase II clinical trial

• Session Type: Poster Session
• Number: 1455P
• Presentation Time: Monday, 16 September 2024(CEST)

Abstract Title: Neoadjuvant SOX combined with cadonilimab (AK104) for PD-L1 negative upper GC/GEJC patients

• Session Type: Poster Session
• Number: 1473TiP
• Presentation Time: Monday, 16 September 2024 (CEST)

Esophageal Squamous Cell Carcinoma
Abstract Title: 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

• Session Type: Poster Session
• Number: 1446P
• Presentation Time: Monday, 16 September 2024 (CEST)