Menarini Group Unveils Promising Findings on ELZONRIS for BPDCN at ASH Meeting

Menarini Group Presents New Data on ELZONRIS® (tagraxofusp-erzs)

The Menarini Group, in collaboration with Stemline Therapeutics, is set to present significant new research on ELZONRIS® at the upcoming 67th Annual American Society of Hematology (ASH) meeting, which will be held from December 6 to 9, 2025, in Orlando. The data includes findings from five abstracts, featuring two oral presentations that highlight critical advancements for patients suffering from blastic plasmacytoid dendritic cell neoplasm (BPDCN).

BPDCN is a rare and highly aggressive hematologic malignancy that can severely affect a patient's skin, bone marrow, and blood, often leading to complex treatment challenges. Menarini’s commitment to innovative oncology therapies is evident in their focus on ELZONRIS, which has shown promising results in recent trials for treating this difficult disease.

During the ASH meeting, a particularly noteworthy oral session will discuss results from a groundbreaking triplet therapy involving tagraxofusp, azacitidine, and venetoclax. This new combination has demonstrated impressive efficacy, including high response rates and improved transplant potential for patients with BPDCN.

Elcin Barker Ergun, CEO of Menarini Group, expressed optimism regarding the latest ELZONRIS data, stating, "Our commitment to transforming the lives of people living with difficult-to-treat cancers is unwavering. These findings underscore the pivotal role of tagraxofusp not only as a monotherapy but also in combination therapies, offering hope to patients faced with numerous hematologic cancers, particularly where there is an urgent need for more effective treatment options."

The research will detail valuable information from various studies, including:

1. Disease Presentation and Immunophenotype Characteristics: At the presentation, researchers will explore the characteristics of BPDCN in a cohort of 257 patients, providing crucial insights into how this neoplasm presents and progresses among different demographics.
2. Triplet Therapy Efficacy: Further data will elucidate the efficacy of the TAG-AZA-VEN (tagraxofusp, azacitidine, venetoclax) treatment, shedding light on patient responses and tolerability during phase 2 trials.
3. Long-Term Survival Studies: A real-world analysis showing a comparison of tagraxofusp versus venetoclax outcomes will also be highlighted, showcasing the potential longer survival benefits linked to tagraxofusp treatment.
4. Impact on Transplant Survival: The results will also emphasize favorable outcomes in patients post-transplant who have been treated with tagraxofusp, providing hope for those who are newly diagnosed as well as those who have undergone prior treatments.
5. Chemotherapy Combinations: Additional research focusing on tagraxofusp and low-intensity chemotherapy for patients displaying CD123-positive relapsed or refractory acute myeloid leukemia will be presented online, ensuring updated information is reached swiftly to the medical community.

ELZONRIS® was initially approved by the FDA back in December 2018 and has since been available for both adult and pediatric patients aged two years and older diagnosed with BPDCN. It provides options for both treatment-naïve patients and those who have undergone previous therapies. Its European Commission approval followed in January 2021.

In recent data trends, BPDCN has been noted to impact individuals across various demographics, with a prevalence of approximately 0.4 to 0.5 per 100,000 annually. The disease is characterized by the presence of a protein known as CD123, which provides an important marker for diagnostic and therapeutic targets. With an aggressive nature, BPDCN is found primarily in older men, often surfacing through noticeable skin lesions as an initial indicator.

With a focus on innovative solutions, the Menarini Group continues to strive for advancements in cancer treatment, underscoring their commitment to addressing unmet medical needs. The upcoming data presentations at ASH 2025 promise to illuminate the potential of ELZONRIS in theranostic strategies, enhancing awareness and understanding around BPDCN, as well as expanding its therapeutic use.

For further details regarding the presentations and the Menarini Group’s ongoing research efforts, please visit the official website or attend the symposium at ASH 2025.