Flamingo Therapeutics Presents Poster at ASCO 2024 on Phase II PEMDA-HN Trial for Head and Neck Squamous Cell Carcinoma (HNSCC)

2024-06-02

临床2期ASCO会议临床1期寡核苷酸

-Trial-in-Progress poster provides overview on PEMDA-HN trial evaluating danvatirsen in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with recurrent/metastatic HNSCC-

LEUVEN, Belgium and STRASBOURG, France and PHILADELPHIA, June 2, 2024 /PRNewswire/ -- Flamingo Therapeutics ("Flamingo") today announced the presentation of a Trial-in-Progress poster at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO 2024) taking place in Chicago, Illinois.

Flamingo's lead oncology program, danvatirsen, is an oligonucleotide discovered by Ionis that selectively targets STAT3 and has shown clinical activity in HNSCC. 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 overall response rate by RECIST 1.1 as assessed by the investigator. The secondary endpoints include safety, duration of response, disease control rate, progression free survival and overall survival. PEMDA-HN is being conducted at study centers in the United States, South Korea and the United Kingdom.

ASCO poster details are as follows:

Abstract#: TPS6113

Title: "PEMDA-HN, an open-label, phase II, randomized controlled study of danvatirsen plus pembrolizumab compared to pembrolizumab alone in first-line recurrent and/or metastatic head and neck squamous cell carcinoma (RM HNSCC)"

Session Title: Poster Session – Head and Neck Cancer

Session Date and Time: June 2, 2024, 9:00am CDT

Presenting Author: Marshall R. Posner, MD, Tisch Cancer Institute Cancer Institute, Icahn School of Medicine at Mount Sinai

For more information, please visit the ASCO 2024 website.

About Flamingo Therapeutics

Flamingo is pioneering RNA-targeted therapies for oncology with a clinical-stage pipeline targeting undruggable transcription factors and long non-coding RNAs. Flamingo has an alliance with Ionis Pharmaceuticals and is supported by well-known biotechnology investors including Abrdn (formerly funds managed by Tekla Capital Management LLC), Andera Partners, Bpifrance Large Venture, Bpifrance through its FABS and Fonds Biothérapies Innovantes et Maladies Rares funds, Eurazeo - Kurma Partners, Perceptive Advisors, PMV, Pontifax, Sphera, and VIB.

Flamingo has initiated a Phase II trial 'PEMDA-HN' evaluating the STAT3 targeting agent danvatirsen, in combination with pembrolizumab, in patients with head and neck squamous cell carcinoma (HNSCC). A Phase I investigator-initiated trial study has also been initiated evaluating danvatirsen as a monotherapy and in combination with venetoclax in AML/MDS patients.

For more information on Flamingo, please visit:

https://flamingotx.com

PEMDA-HN (head and neck cancer) on clinicaltrials.gov:

https://clinicaltrials.gov/study/NCT05814666