Flamingo Therapeutics Presents Phase II PEMDA-HN Trial for HNSCC at ASCO 2024

Flamingo Therapeutics recently showcased a Trial-in-Progress poster at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO 2024) in Chicago, Illinois. The poster provides an overview of the PEMDA-HN trial, which evaluates the efficacy and safety of danvatirsen in combination with pembrolizumab, compared to pembrolizumab alone, in treating patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1.

Danvatirsen, an oligonucleotide discovered by Ionis, selectively targets STAT3 and has demonstrated clinical activity in HNSCC. The Phase II PEMDA-HN study (NCT05814666) is a multicenter, open-label, randomized trial. It aims to assess the treatment efficacy and safety of danvatirsen combined with pembrolizumab against pembrolizumab alone as a first-line therapy for patients with recurrent/metastatic HNSCC. The trial involves multiple study centers located in the United States, South Korea, and the United Kingdom.

In the study, patients are randomized in a two-to-one ratio where two-thirds receive the combination of danvatirsen and pembrolizumab, while the remaining third receive pembrolizumab only. The primary endpoint of the study focuses on the overall response rate, as determined by RECIST 1.1 criteria assessed by investigators. Secondary endpoints include safety profiles, duration of response, disease control rate, progression-free survival, and overall survival.

The ASCO 2024 poster, titled "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)," was presented during the Poster Session for Head and Neck Cancer on June 2, 2024. The presenting author was Dr. Marshall R. Posner from the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai.

Flamingo Therapeutics is at the forefront of developing RNA-targeted therapies for oncology. The company’s clinical-stage pipeline targets transcription factors and long non-coding RNAs that are typically considered undruggable. Flamingo has formed a strategic alliance with Ionis Pharmaceuticals and has backing from prominent biotechnology investors including Abrdn, Andera Partners, Bpifrance Large Venture, Eurazeo - Kurma Partners, Perceptive Advisors, PMV, Pontifax, Sphera, and VIB.

In addition to the PEMDA-HN trial, Flamingo is also conducting a Phase I investigator-initiated study evaluating danvatirsen as a monotherapy and in combination with venetoclax in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

Flamingo Therapeutics continues to advance its innovative approach to oncology treatment, leveraging their expertise in RNA biology to target challenging cancer types. Their ongoing clinical trials represent a significant step towards potentially providing new therapeutic options for patients with difficult-to-treat cancers.