Akeso, Inc. has announced promising interim results for its bispecific antibodies, ivonescimab and cadonilimab, alongside advancements in its broader oncology pipeline. These developments signal Akeso's growing influence in the cancer immunotherapy landscape. The company's innovative approach, particularly with bispecific antibodies, is addressing unmet needs in various cancer types.
Ivonescimab Demonstrates Efficacy in Lung Cancer
Ivonescimab (PD-1/VEGF bispecific antibody) has achieved significant milestones in lung cancer treatment. In May 2024, it was approved in China for epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC), based on the HARMONi-A study. This Phase III trial demonstrated a significant benefit across all subgroups for progression-free survival (PFS) and showed a positive trend in overall survival (OS).
Furthermore, the HARMONi-2 study revealed that ivonescimab monotherapy outperformed pembrolizumab monotherapy in patients with PD-L1 positive (TPS≥1%) locally advanced or metastatic NSCLC. This led to the NMPA granting priority review for the supplemental New Drug Application (sNDA) for ivonescimab in this indication. Akeso is positioning ivonescimab as a potential new standard treatment for first-line lung cancer, offering a chemotherapy-free option.
Ligufalimab Enters Phase III Trials
The Phase III trial of ligufalimab (CD47 monoclonal antibody, AK117) for first-line head and neck squamous cell carcinoma (vs. pembrolizumab) has commenced, marking it as the first CD47 mAb to enter Phase III for solid tumors. This trial underscores Akeso's commitment to exploring novel targets and treatment modalities.
Cadonilimab Shows Broad Benefit
Cadonilimab (PD-1/CTLA-4 bispecific antibody) continues to gain recognition in cancer immunotherapy. Submissions for first-line advanced gastric and cervical cancer treatments are under regulatory review, highlighting its potential in tumors with low or negative PD-L1 expression. Cadonilimab has been involved in multiple pivotal/Phase III clinical trials, including those for hepatocellular carcinoma and non-small cell lung cancer.
Ivonescimab Shows Efficacy in Metastatic Colorectal Cancer
At the 2024 European Society for Medical Oncology (ESMO) Conference, Akeso presented efficacy data for ivonescimab, with or without ligufalimab, in combination with FOLFOXIRI as a first-line (1L) treatment for metastatic colorectal cancer (mCRC). The results indicated that both regimens demonstrate high anti-tumor activity and effective disease control for first-line treatment of MSS/pMMR mCRC. The objective response rate (ORR) was 88.2%, and the disease control rate (DCR) was 100%. At a median follow-up of 9.6 months, the median progression-free survival (mPFS) has not yet been reached, with a 9-month PFS rate of 86.2%.
Advancing a Diverse Pipeline
Akeso is actively advancing over 10 new therapies into clinical trials, including bispecific antibodies and its first differentiated ADC product, AK138D1 (HER3 ADC). The company is also developing preclinical candidates, such as bispecific antibody AK137 (CD73/LAG-3) and trispecific antibody AK150, to further expand its oncology portfolio.
With a robust pipeline and promising clinical data, Akeso is poised to make significant contributions to cancer treatment in the coming years.
