Chinese biopharmaceutical company Akeso Inc (HK:9926) announced on Tuesday that the first patient has been successfully enrolled in the registration Phase III clinical trial (AK112-312/HARMONi-GI6) of ivonescimab in first-line treatment for advanced metastatic colorectal cancer (mCRC).

The company says that this randomised, controlled, multi-centre Phase III clinical trial for first-line treatment of mCRC is one of its key initiatives to address the significant unmet clinical need worldwide with ivonescimab.

At the 2024 European Society for Medical Oncology (ESMO) Congress, Professor Yanhong Deng from the Sixth Affiliated Hospital of Sun Yat-sen University presented promising Phase II efficacy data of ivonescimab in combination with chemotherapy for first-line treatment of MSS/pMMR-type mCRC.

The combination of ivonescimab with FOLFOXIRI has demonstrated anti-tumour activity in this hard-to-treat patient population, with an overall response rate (ORR) of 81.8% and a disease control rate (DCR) of 100%. After a median follow-up of 9 months, the median progression-free survival (mPFS) was not reached, with a 9-month PFS rate of 81.4%. Regardless of KRAS/BRAF mutation status, patients can benefit from ivonescimab combination therapy, Akeso said.

Results published at the 2024 ESMO suggest that ivonescimab may offer a significant improvement over existing treatment options for MSS/pMMR mCRC patients. The Phase III trial AK112-312/HARMONi-GI6 can potentially further validate the clinical benefits of ivonescimab in this setting, offering a novel first-line immunotherapy treatment option for patients with advanced mCRC.