Akeso Releases Initial Efficacy Data for Ivonescimab in mCRC at ESMO 2024

At the 2024 European Society for Medical Oncology (ESMO) Conference, Akeso unveiled promising efficacy data for its innovative PD-1/VEGF bispecific antibody, ivonescimab, both as a monotherapy and in combination with ligufalimab (an anti-CD47 antibody), alongside the chemotherapy regimen FOLFOXIRI. This combination is being investigated as a first-line treatment for metastatic colorectal cancer (mCRC). Professor Yanhong Deng from the Sixth Affiliated Hospital of Sun Yat-Sen University provided an oral presentation on these findings.

Colorectal cancer that is microsatellite stable (MSS) and mismatch repair proficient (pMMR) has long posed a challenge for immunotherapy due to its resistance to current treatments. Typically, chemotherapy combined with bevacizumab or cetuximab is the standard initial treatment for MSS/pMMR mCRC patients, yet this approach offers limited efficacy.

By February 29, 2024, the median follow-up period was 9.6 months for patients receiving the ivonescimab and ligufalimab combination with FOLFOXIRI, and 9.0 months for those receiving ivonescimab with FOLFOXIRI alone. Findings highlighted strong anti-tumor activity and effective disease control in both regimens for the first-line treatment of MSS/pMMR mCRC. Importantly, the combination treatment with ligufalimab exhibited superior anti-tumor efficacy, with preliminary data showing significant improvements over existing standard treatments.

For patients treated with ivonescimab, either alone or in conjunction with ligufalimab and FOLFOXIRI, the objective response rate (ORR) reached 88.2%, and the disease control rate (DCR) was at 100%. At a median follow-up of 9.6 months, the median progression-free survival (mPFS) has not been reached, with a 9-month progression-free survival (PFS) rate of 86.2%.

When ivonescimab was combined solely with FOLFOXIRI for treating MSS/pMMR mCRC, the ORR was 81.8%, and the DCR remained at 100%. At a median follow-up duration of 9 months, the mPFS had not been reached, with a 9-month PFS rate of 81.4%.

Both treatment groups exhibited acceptable safety profiles, with manageable treatment-related adverse events (TRAEs).

These encouraging results support further detailed evaluation of ivonescimab, both as a standalone treatment and in combination with ligufalimab, alongside chemotherapy for the initial treatment of MSS/pMMR mCRC.