Towards Healthcare

Akeso Begins Phase 3 Trial for Ivonescimab as First-Line Treatment in Advanced Colorectal Cancer

Akeso Inc. has enrolled the first patient in its Phase 3 trial of Ivonescimab for advanced colorectal cancer. The study aims to offer a breakthrough first-line immunotherapy option for MSS/pMMR mCRC patients.

Author: Towards Healthcare Published Date: 18 July 2025
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Akeso Enrolled First Patient for MCRc

Researchers at Akeso initiating a Phase 3 clinical trial for Ivonescimab targeting advanced colorectal cancer patients

Akeso Inc. has enrolled its first patient in the registration phase 3 clinical trial AK112-312/HARMONi-GI6 of ivonescimab for its primary treatment of advanced metastatic colorectal cancer (mCRC). The phase 3 trial is a center for the company to achieve primary treatment for MCRC. The company’s main efforts are to identify and provide the required clinical needs with Ivonescimab globally. Further, the results of this promising trial will lead to the discovery of a new therapy in the healthcare market.

About MCRc

Colorectal cancer is a common cancer worldwide and the second most common reason for cancer–based deaths. Around 1.9 million cases were registered, including 904,000 deaths, in 2022. Around 95% of MCRC cases are differentiated as microsatellite stable (MSS) or proficient mismatch repair (pMMR). This differentiation has a dull response to the tumors and immunotherapy, as it is popularly known as ‘immune desert’. The 95% cases are under primary treatment of MSS/PMMR-type mcrc, and various PD-1/L1 inhibitors are addressed in several international studies. Though the efficacy has not reached its expectation, for now, there’s no primary immunotherapy that is approved worldwide for Pmmr/MSS-type MCRC patients.

Merged Therapies

The chemotherapy combined with targeted therapies like cetuximab, bevacizumab, etc, is a preferred common treatment for MRCR. It doesn’t have much efficacy and ensures 5 5-year survival rate of less than 20% patients. Whereas, bevacizumab is a developed and clinically effective treatment in the mcrc also a maijor indication of bevacizumab. Professor Yanhong Deng from the Hospital of sun yat-sen University, at the European Society for Medical Oncology (ESMO) congress 2024, showcased excellent phase 2 efficacy data of ivonescimab in chemotherapy as a first-line treatment of MSS/PMMR-type mCRC.

Another is the merger of Ivonescimab with FOLFOXIRI elaborates a compatible anti-tumor activity for the difficult treatment, with an overall response rate (ORR) of 81.8% and disease control rate (DCR) of 100%. After the 9 months of follow-up the median progression free survival (mpfs) did not touch the 9-month PFS rate of 81.4%. Even in the absence of KRAS/BRAF mutation status, patients can receive a positive and beneficial response from the ivonescimab combination therapy. The EMSO 2024 results show that Ivonescimab can serve promising improvement over existing treatment alternatives for MSS/PMMR MCRC patients. The phase 3 trial AK112-312/HARMONi-GI6 is eligible to address the clinical benefits of ivonescimab in this space, which will provide a remarkable first-line immunotherapy treatment option for advanced MCRC patients.

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