NEW YORK – Akeso Biopharma on Wednesday said it dosed the first patient with PD-L1-positive advanced head and neck cancer in a Phase III trial, comparing the activity of its PD-1/VEGF bispecific antibody ivonescimab (AK112) plus the anti-CD47 monoclonal antibody ligufalimab (AK117) versus Merck's checkpoint inhibitor Keytruda (pembrolizumab).
In the AK117-302 trial, the Hong Kong-based company will enroll approximately 510 patients with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck to receive either first-line ivonescimab-ligufalimab or Keytruda-placebo. Akeso will track overall survival as the primary outcome measure of the trial. Secondary outcome measures will include progression-free survival and objective response rate.
About 770,000 new cases of head and neck cancer were reported globally in 2022, with 84,000 patients diagnosed in China, and squamous cell carcinoma accounts for 90 percent of those cases. However, even with currently available targeted therapies and immunotherapies such as Keytruda, median overall survival is less than a year. Akeso believes ivonescimab-ligufalimab could improve patients' outcomes, particularly long-term survival. Earlier data reported by the company have suggested the combination can significantly shrink tumors and improve head and neck cancer patients' survival.
Akeso licensed ivonescimab from Summit Therapeutics in 2022 and is evaluating the drug in four other Phase III clinical trials. In September, the company shared results from the Phase III HARMONi-2 trial, in which patients with advanced, PD-L1-positive non-small cell lung cancer survived 11.14 months free of disease progression or death compared to 5.82 months for those on Keytruda. The firm is also evaluating ivonescimab plus chemotherapy in a Phase III trial in advanced, EGFR-mutated, non-squamous, NSCLC patients after they receive an EGFR tyrosine kinase inhibitor.