Akeso Presents Ivonescimab and Ligufalimab for PD-L1-Positive Head and Neck Cancer at ESMO 2024

At the 2024 European Society for Medical Oncology (ESMO) Conference held in Hong Kong, Akeso presented promising Phase 2 clinical trial results for its innovative PD-1/VEGF bispecific antibody, ivonescimab. This treatment, studied alone and in combination with ligufalimab (an anti-CD47 antibody designated AK117), is aimed at first-line treatment of PD-L1-positive (CPS≥1) recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

As of the data cut-off on March 19, 2024, the initial results show that ivonescimab has led to significant tumor size reduction in patients with R/M HNSCC, a cancer type in urgent need of effective therapies. More notably, when ivonescimab is paired with ligufalimab, the treatment demonstrated even greater efficacy in terms of both tumor shrinkage and patient survival rates compared to ivonescimab alone. These preliminary results suggest that the combination therapy exceeds the performance of previously studied PD-1 inhibitors.

Key metrics from the trial indicate that the objective response rate (ORR) for the ivonescimab monotherapy group stands at 30%, which doubles to 60% when ligufalimab is added. The disease control rate (DCR) also shows improvement, rising from 80% with ivonescimab alone to 90% when combined with ligufalimab. Encouragingly, some patients who initially exhibited stable disease (SD) experienced an upgrade to partial response (PR). Overall ORR for ivonescimab monotherapy reached 40%, while the combination therapy achieved 65%.

In assessing progression-free survival (PFS), the median PFS (mPFS) for patients receiving only ivonescimab was 5.0 months, with the 6-month PFS rate still to be determined. For those treated with the combination of ivonescimab and ligufalimab, the mPFS extended to 7.1 months, accompanied by a 6-month PFS rate of 71.8%.

The safety profile of ivonescimab, both as a standalone treatment and in combination with ligufalimab, appears manageable. There were no treatment-related adverse events (TRAE) severe enough to cause discontinuation or death reported in either group.

Current first-line treatment for recurrent/metastatic HNSCC largely revolves around PD-1 inhibitors used in conjunction with chemotherapy. However, this standard approach does not yield satisfactory results for all patients, underlining the critical need for new therapeutic options. In response, Akeso has initiated a Phase 3 clinical trial to directly compare the efficacy of the ivonescimab-ligufalimab combination against pembrolizumab for treating PD-L1 positive R/M HNSCC. This ongoing study holds promise for introducing a potent new immunotherapy alternative and advancing the field of cancer immunotherapy.