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Leuven (Belgium), Strasbourg (France), Philadelphia (USA) – February 14, 2024 /PRNewswire/-

Flamingo Therapeutics (“Flamingo”) today announced that the first patient has been dosed in its PEMDA-HN trial 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.   The global study is planned to be conducted at study centers in the United States, Korea and the United Kingdom.

“We are excited to launch this study and evaluate the combination of a STAT3 targeting agent, danvatirsen, with an established checkpoint inhibitor used in first-line therapy for this difficult-to-treat cancer population.  Based on the potential synergy of the mechanisms of action, we aim to improve upon the overall response rates of pembrolizumab alone to better serve HNSCC patients,” said Andrew Denker, MD, CMO of Flamingo. “We are grateful for the contribution of all participants in this study and for the support of our clinical collaborators at each site.”

Recurrent/metastatic HNSCC is considered an incurable disease with poor prognosis and limited treatment options. It requires active treatment from the early stages and significantly impacts patients’ lives, causing functional disability and a high mortality rate.

"Our site is very excited about being the first enrollment on this important head and neck trial.  The data is important to establish the effectiveness of the combination therapy with Danvatirsen and Pembrolizumab.  We are thankful to Flamingo for giving us the opportunity to have this treatment option for our patients here in Kansas City," added Dr. Jaswinder Singh, AMR Kansas City Oncology, Kansas City.

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.  More information on PEMDA-HN can be found here.

Dr. Nabil F. Saba, Emory Winship Cancer Institute and Chair of the PEMDA-HN Protocol Steering Committee, added, “I am enthusiastic about the PEMDA-HN trial.  I believe the combination of danvatirsen and pembrolizumab has tremendous promise to treat patients with head and neck cancer.  Our center is proud to be participating in this important clinical study.”