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New Insights into ELZONRIS® (tagraxofusp-erzs)

Menarini Group is set to reveal groundbreaking data on its cancer treatment ELZONRIS® (tagraxofusp-erzs) at the 67th Annual Meeting of the American Society of Hematology (ASH) in December 2025. This pivotal event, taking place from December 6-9 in Orlando, promises to shed light on significant advancements for patients battling blistering plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive form of hematological malignancy.

Background on BPDCN

BPDCN is a highly aggressive hematological cancer that predominantly affects the skin, bone marrow, and blood, and has a global prevalence estimated between 0.4 and 0.5 per 100,000 people annually. Symptoms tend to manifest in the form of skin lesions, primarily impacting males, with a median onset age between 60 and 70 years. The cancerous cells are distinguished by their high expression of the CD123 protein, which serves as both a diagnostic marker and a target for precision therapies.

Major Findings to be Presented

The data to be presented encompasses five abstracts, including two oral presentations that highlight key findings from a study on ELZONRIS's efficacy. One of these presentations focuses on a triplet therapy involving tagraxofusp, azacitidine, and venetoclax, showcasing promising results in both efficacy and tolerability among BPDCN patients.

Elcin Barker Ergun, CEO of Menarini Group, emphasized the company’s unwavering commitment to transforming the lives of individuals facing challenging-to-treat cancers. He remarked, “These findings indicate that tagraxofusp plays a crucial role not only as monotherapy but also in combination therapy for BPDCN. It holds potential to help patients with other aggressive hematological malignancies, where more effective treatment options are urgently needed.”

Details of Upcoming Presentations

The oral and poster presentations include:

• - Disease Presentation and Immunophenotype Characteristics in BPDCN: A study illustrating the characteristics in 257 patients, scheduled for December 6.
• - Triple Therapy Efficacy: Findings from a Phase 2 trial demonstrating efficacy and transplant potential in BPDCN patients through the TAG-AZA-VEN regimen, set for presentation on December 7.
• - Real-World Analysis of Tagraxofusp: A poster detailing longer survival rates with tagraxofusp compared to venetoclax, on display December 7.
• - Post-Transplant Outcomes: Analysis showing favorable post-transplant survival rates independent of baseline skin involvement, scheduled for December 8.
• - Combination Treatment Efficacy: Exploration of tagraxofusp alongside low-intensity chemotherapy for patients with relapsed or refractory acute myeloid leukemia, to be published online.

The Importance of This Research

The studies aim to provide clarity on the clinical utility of ELZONRIS, which was approved by the FDA in December 2018 for treating BPDCN in adults and pediatric patients aged two years and older. As this malignancy can sharply affect quality of life and has limited treatment options, the findings could represent a critical step forward in patient care, offering hope through innovative therapies.

With a strong emphasis on unmet medical needs, Menarini Group aims to continue its legacy of pioneering treatments in oncology, pulmonary medicine, and beyond. This commitment is underpinned by a robust pipeline and a global presence that spans 140 countries.

For more details, visit Menarini Group and stay tuned for updates from the ASH Annual Meeting, where transformative advancements in cancer treatment may reshape patient outcomes across the globe.