HONG KONG, Sept. 15, 2024 — Akeso (9926.HK) unveiled the first efficacy data for its proprietary PD-1/VEGF bispecific antibody, ivonescimab, both alone and combined with ligufalimab (anti-CD47 antibody AK117) , in tandem with FOLFOXIRI as a first-line (1L) treatment for metastatic colorectal cancer (mCRC) at the 2024 European Society for Medical Oncology (ESMO) Conference. The study’s lead researcher, Professor Yanhong Deng from the Sixth Affiliated Hospital of Sun Yat-Sen University, presented these findings orally at the conference.

Metastatic colorectal cancer (mCRC) tumors characterized by microsatellite stability (MSS) and mismatch repair proficiency (pMMR) have historically been considered “immunological deserts,” with prior immunotherapy attempts yielding minimal benefits. The prevailing first-line treatment for MSS/pMMR mCRC patients involves combining chemotherapy with bevacizumab or cetuximab, but this approach has demonstrated limited therapeutic effectiveness.

As of February 29, 2024, the median follow-up time for the ivonescimab plus ligufalimab combination with FOLFOXIRI group was 9.6 months, and 9.0 months for the ivonescimab plus FOLFOXIRI group. These results indicated that both treatment regimens exhibit significant anti-tumor activity and effective disease control in the first-line treatment of MSS/pMMR mCRC, demonstrating promising preliminary long-term outcomes. Importantly, the combination of ivonescimab with ligufalimab demonstrated superior anti-tumor efficacy, with preliminary data from both groups surpassing existing standard treatments.

• In the first-line treatment of MSS/pMMR mCRC using ivonescimab, either alone or in combination with ligufalimab and FOLFOXIRI, the objective response rate (ORR) was 88.2%, and the disease control rate (DCR) was 100%. With a median follow-up of 9.6 months, the median progression-free survival (mPFS) has not yet been reached, showing a 9-month PFS rate of 86.2%.
  • In the first-line treatment of MSS/pMMR mCRC where ivonescimab was combined with FOLFOXIRI, the ORR reached 81.8% and the DCR was 100%. At a median follow-up of 9 months, the median PFS remains undetermined, with a 9-month PFS rate of 81.4%.
• Both treatment groups displayed acceptable safety profiles, with manageable treatment-related adverse events (TRAEs).
• The study findings support further investigation of ivonescimab, both as a standalone treatment and in combination with ligufalimab, alongside chemotherapy for first-line treatment of MSS/pMMR mCRC.

SOURCE Akeso, Inc.