Akeso's Phase 3 Trial Begins for Ivonescimab and Ligufalimab Combination in Head and Neck Cancer
核心洞察
Akeso (搜索) initiates a Phase 3 trial (AK117-302) evaluating ivonescimab plus ligufalimab versus pembrolizumab for first-line treatment of PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (搜索) (HNSCC (搜索)).
This study marks the first global Phase 3 investigation of a CD47 (搜索) monoclonal antibody therapy (ligufalimab) in solid tumors, highlighting Akeso (搜索)'s commitment to innovative cancer immunotherapy.
Preliminary data from the combination therapy of ivonescimab and ligufalimab presented at ESMO 2024 showed significant tumor reduction and survival benefits in HNSCC (搜索) patients.
Akeso (搜索) Biopharma has announced the enrollment of the first patient in its Phase 3 clinical trial (AK117-302) evaluating the combination of ivonescimab, a PD-1 (搜索)/VEGF (搜索) bispecific antibody, and ligufalimab (AK117), a next-generation CD47 (搜索) monoclonal antibody, for the first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (搜索) (R/M HNSCC (搜索)). The trial compares this combination therapy to pembrolizumab in patients with PD-L1 positive (CPS≥1) R/M HNSCC.
This Phase 3 study is a randomized, controlled, multicenter trial and represents a significant step forward as the first global Phase 3 clinical trial to investigate a CD47 (搜索) monoclonal antibody therapy for solid tumors. It is also the fifth Phase III study for ivonescimab, using PD-1 (搜索)/L1 monoclonal antibody therapy as a positive control, and the third Phase III study comparing ivonescimab with pembrolizumab.
Addressing Unmet Needs in HNSCC
Head and neck cancer is a significant global health burden, with 770,000 new cases reported worldwide in 2022, including 84,000 cases in China. Squamous cell carcinoma accounts for over 90% of these cancers. The five-year survival rate for patients with recurrent/metastatic HNSCC (搜索) is notably low, at just 3.6%. While therapies like pembrolizumab have improved treatment options, the median overall survival (OS) remains below one year, highlighting the urgent need for more effective treatments.
Pembrolizumab is a first-line standard treatment for R/M HNSCC (搜索), recommended in both CSCO and NCCN guidelines. Akeso (搜索) aims to improve outcomes for HNSCC patients and help them achieve long-term survival through this trial.
Promising Early Data
At the 2024 European Society for Medical Oncology (ESMO) Congress, Akeso (搜索) presented encouraging initial data on the ivonescimab and ligufalimab combination. The therapy demonstrated significant tumor reduction and survival benefits, particularly in HNSCC (搜索) patients who require rapid tumor shrinkage. The preliminary efficacy data surpassed that of previously disclosed PD-1 (搜索) studies, suggesting its potential as a new immunotherapy option for HNSCC patients.
About Ligufalimab and Ivonescimab
Ligufalimab (AK117) is a humanized IgG4 anti-CD47 (搜索) antibody developed by Akeso (搜索). It binds to CD47 expressed on tumor cells, blocking the interaction between CD47 and SIRPα, thereby enhancing the phagocytic activity of phagocytes on tumor cells and inhibiting tumor growth. Several Phase II clinical trials are underway to explore ligufalimab's potential in combination with other therapies for hematological and solid tumors.
Ivonescimab (AK112/SMT112) is a PD-1 (搜索)/VEGF (搜索) bi-specific immunotherapy drug independently developed by Akeso (搜索). It has already received marketing approval in China for the treatment of EGFR-mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Akeso is currently conducting six registrational trials of ivonescimab versus anti-PD-1/L1 therapeutics, as well as multiple clinical trials covering 17 indications, including gastrointestinal cancer, hepatocellular carcinoma, and colorectal cancer.