Flamingo Therapeutics today announced that the PEMDA-HN trial has expanded beyond the United States into the UK and Korea.
Patient enrollment in the USA started in February 2024 and now the first patients have been dosed in these new geographies. The PEMDA-HN trial is evaluating danvatirsen in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
Flamingo’s lead oncology program, danvatirsen, is an antisense oligonucleotide discovered by Ionis that selectively targets STAT3 and has shown clinical activity in HNSCC.
“HNSCC is a difficult-to-treat cancer, with approximately 890,000 new cases each year globally, and accounts for almost 5% of global cancer deaths. Patients are in need of new therapies and we are pleased to have expanded our study beyond the United States,” said Andrew Denker, MD PhD, CMO of Flamingo. “This is a significant milestone in the advancement of the PEMDA-HN study, and we are thankful for the support of our study participants, their families and our global collaborators.”
Dr. Kevin Harrington, Consultant Oncologist at The Royal Marsden NHS Foundation Trust and Professor of Biological Cancer Therapies at The Institute of Cancer Research, London, commented, “STAT3 blocking using Flamingo’s investigational therapy, danvatirsen, is a potential novel approach to help patients with HNSCC in my clinic. I am pleased that my patients have an opportunity to participate in the PEMDA-HN trial, which I believe may greatly benefit the global oncology field.”
PEMDA-HN (NCT05814666) is a multicenter, open-label, randomized study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic HNSCC whose tumor expresses PD-L1. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone. The primary endpoint of the study is to determine the overall response rate by RECIST 1.1 as assessed by the investigator. The secondary endpoints will include safety, duration of response, disease control rate, progression free survival and overall survival.
