Flamingo Therapeutics has dosed the first patients in the UK and South Korea in the ongoing Phase II PEMDA-HN clinical trial, which is assessing the combination of danvatirsen and MSD’s Keytruda (pembrolizumab) for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
The move marks the expansion of the trial, which began enrolling patients in the US in February this year.
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Danvatirsen is Flamingo’s lead oncology programme. Discovered by Ionis Pharmaceuticals, it is an antisense oligonucleotide that targets signal transducer and activator of transcription 3 (STAT3) and has demonstrated clinical activity in HNSCC.
The multi-centre, open-label, randomised study aims to assess the safety and efficacy of danvatirsen and pembrolizumab against pembrolizumab alone as first-line treatment of patients with programmed death-ligand 1 (PD-L1) expressing tumours.
Two-thirds of subjects will be randomised to receive the combination therapy and one-third will receive only pembrolizumab.
The study’s primary endpoint is to determine the overall response rate while the secondary endpoints will focus on response duration, safety, disease control rate, progression-free survival and overall survival.
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By GlobalDataFlamingo CMO Andrew Denker said: “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 US.
“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.”
In addition to the PEMDA-HN trial, Flamingo has initiated a Phase I study to investigate danvatirsen as both a monotherapy and in combination with venetoclax for patients with AML/MDS.
