Akeso's Phase III Clinical Trial of Ivonescimab Launched for Advanced Colorectal Cancer Treatment

Akeso Initiates Groundbreaking Phase III Trial



Akeso, Inc. has recently announced a significant milestone in its quest for innovative cancer therapies. The company has successfully enrolled the first patient in its Phase III clinical trial (AK112-312/HARMONi-GI6) assessing ivonescimab as a first-line treatment for advanced metastatic colorectal cancer (mCRC). This is a pivotal step in an ongoing effort to address a pressing unmet clinical need.

Colorectal cancer stands as one of the most concerning health issues worldwide, ranking as the third most prevalent cancer and the second leading cause of cancer mortality. According to statistics from 2022, the world witnessed over 1.9 million new cases and approximately 904,000 associated deaths. A staggering 95% of metastatic cases are categorized as microsatellite stable (MSS) or proficient mismatch repair (pMMR), which have historically shown poor responses to traditional immunotherapy due to their unfavorable immunological landscape.

While various PD-1/L1 inhibitors have been explored for the treatment of MSS/pMMR mCRC patients, their effectiveness has been limited. As it stands, there are no approved immunotherapy options for this substantial subset of patients. Current therapeutic regimens primarily revolve around chemotherapy combined with targeted therapies such as bevacizumab and cetuximab, which, despite being the standard care, offer limited efficacy with a disheartening five-year survival rate of less than 20% for advanced stages.

At the 2024 European Society for Medical Oncology (ESMO) Congress, promising Phase II data was presented by Professor Yanhong Deng from the Sixth Affiliated Hospital of Sun Yat-sen University. The trial showcased the efficacy of ivonescimab in conjunction with chemotherapy (specifically FOLFOXIRI), demonstrating a remarkable overall response rate of 81.8% and a disease control rate of 100%. Following a median follow-up of nine months, participants achieved an impressive nine-month progression-free survival rate (PFS) of 81.4%. Notably, the benefits of this combination therapy transcend KRAS/BRAF mutation status.

The compelling findings shared at ESMO indicate that ivonescimab could significantly enhance treatment outcomes for patients with MSS/pMMR colorectal cancer, offering potentially groundbreaking advancements in therapeutic options. The commencement of Phase III trial AK112-312/HARMONi-GI6 serves as a critical juncture in further consolidating the clinical benefits of ivonescimab, heralding a new era of first-line immunotherapy for advanced mCRC patients.

Challenges and Future Outlook


Akeso, Inc. acknowledges the inherent risks and uncertainties accompanying these forward-looking statements. Current industry conditions, competitive landscapes, regulatory hurdles, and general economic factors significantly impact the trajectory of pharmaceutical developments. Although the firm maintains a well-integrated R&D approach and an extensive pipeline with over 50 innovative assets, the pathway to regulatory approval and commercial success remains fraught with challenges.

In an era where effective treatments for mCRC are desperately needed, ivonescimab's Phase III trial may bring hope not only to patients but also to the medical community grappling with colorectal cancer treatment. With Akeso's strong commitment to innovation and patient care, the potential realization of a first-line immunotherapy could ultimately reshape the landscape of mCRC management.

Topics Health)

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