Akeso Published First-Ever Efficacy Data for PD-1/VEGF Bispecific Antibody Ivonescimab with or without CD47 Antibody plus FOLFOXIRI for mCRC at ESMO 2024

HONG KONG, Sept. 15, 2024 /PRNewswire/ —  At the 2024 European Society for Medical Oncology (ESMO) Conference, Akeso (9926.HK) presented efficacy data for the first time for its internally developed PD-1/VEGF bispecific antibody, ivonescimab, with or without ligufalimab (anti-CD47 antibody AK117) , in combination with FOLFOXIRI as a first-line (1L) treatment for metastatic colorectal cancer (mCRC). The principal investigator of the study, Professor Yanhong Deng from the Sixth Affiliated Hospital of Sun Yat-Sen University, delivered an oral presentation at the conference.

Microsatellite stable (MSS) and mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC) tumors have long been considered “immunological deserts,” with prior attempts at immunotherapy offering minimal benefits. The current standard first-line treatment for MSS/pMMR mCRC patients remains a combination of chemotherapy with bevacizumab or cetuximab, which has shown limited therapeutic efficacy.

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. Results indicated that both regimens demonstrate high anti-tumor activity and effective disease control for first-line treatment of MSS/pMMR mCRC, with promising preliminary long-term outcomes. Notably, the combination of ivonescimab with ligufalimab showed superior anti-tumor efficacy, with preliminary data from both groups significantly surpassing existing standard treatments.

• For first-line treatment of MSS/pMMR mCRC with 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%. At a median follow-up of 9.6 months, the median progression-free survival (mPFS) has not yet been reached, with a 9-month PFS rate of 86.2%.
  • In the first-line treatment of MSS/pMMR mCRC with ivonescimab combined with FOLFOXIRI, the ORR was 81.8% and the DCR was 100%. At a median follow-up of 9 months, the median PFS has not yet been reached, with a 9-month PFS rate of 81.4%.
• Both groups demonstrated acceptable safety profiles, with manageable treatment-related adverse events (TRAEs).
• The study results support further evaluation of ivonescimab, either alone or in combination with ligufalimab, with chemotherapy for first-line treatment of MSS/pMMR mCRC.