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Menarini Group Unveils New ELZONRIS® Data at ASH 2025

In a significant development for hematological oncology, Menarini Group announced its upcoming presentation of fresh data concerning ELZONRIS® (tagraxofusp-erzs) at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH). The event is scheduled to occur from December 6 to 9, 2025, in Orlando, Florida. This presentation comes as a beacon of hope for patients battling blastoid plasmacytoid dendritic cell neoplasms (BPDCN), a rare and aggressive hematological cancer.

Key Findings from the Presentations

The presentation will include five abstracts, two of which will be delivered as oral presentations, providing crucial insights into the treatment of BPDCN. This specific form of neoplasm is characterized by its aggressiveness and impacts primarily the skin, bone marrow, and blood.

Among the invaluable insights, one of the talks will detail the results of a triplet therapy that combines Tagraxofusp, Azacitidine, and Venetoclax. Preliminary results reveal high response rates and significant bridging rates leading up to transplantation, underscoring ELZONRIS’s pivotal role in treating patients with BPDCN.

Elcin Barker Ergun, CEO of Menarini Group, expressed optimism, stating, “At Menarini Stemline, we are dedicated to improving the lives of those suffering from hard-to-treat cancers. These new data illustrate the potential of Tagraxofusp in both mono and combination therapies for BPDCN and suggest its effectiveness could extend to patients with other aggressive hematologic malignancies that desperately need better treatment options.”

Detailed Presentation Schedule

• - December 6, 2025: Navarro Vicente I, et al., will present on the disease profile and immunophenotypic features in 257 patients with BPDCN in a session titled “Acute Myeloid Leukemias.” This oral presentation is expected to shed light on the characteristics that define this rare cancer, offering a clearer diagnostic framework.

• - December 7, 2025: A second major presentation will focus on how the triplet therapy of Tagraxofusp, Azacitidine, and Venetoclax (TAG-AZA-VEN) produced promising results, demonstrating both efficacy and tolerability in BPDCN patients. This phase 2 study aims to present critical data reflecting the treatment's potential, also part of the “Drugs under Investigation” session.

Following this, there will be a poster presentation by Stein et al., detailing comparative survival analysis for patients treated with Tagraxofusp against those treated with Venetoclax, providing real-world data that may influence future treatment paradigms.

This data is not only pertinent for practitioners but may interest anyone monitoring advancements in the treatment of complex hematological disorders.

Background on BPDCN and ELZONRIS

BPDCN represents a significant challenge within the realm of hematological cancers, characterized by a high prevalence of cutaneous lesions and affecting patients across diverse demographics. Its manifestations can escalate quickly, requiring urgent and effective therapeutic interventions.

ELZONRIS was granted FDA approval in December 2018 to treat BPDCN in adult and pediatric patients aged two years and older, highlighting a critical development in the landscape of treatment options for this rare malignancy, particularly for those unresponsive to prior therapies.

According to recent insights, approximately 85-90% of BPDCN patients present with skin lesions as their first symptom. The context of these discussions at ASH 2025 will emphasize the need for awareness and further investigation of this rare malignancy, ensuring that patients receive timely and effective therapies.

In advance of the ASH meeting, Menarini and Stemline continue to ensure that professionals are equipped with the latest research and findings, emphasizing the importance of collaborative efforts in addressing unmet medical needs. Follow the developments and robust discussions that are shaping the future treatment paradigms for BPDCN and beyond.

Conclusion

The upcoming ASH 2025 Annual Meeting promises to be a significant milestone for researchers and healthcare professionals dedicated to fighting hematologic malignancies. The fresh data presented on ELZONRIS® will not only illuminate pathways for improved treatment but also engage a wider community in discussions around innovative approaches to cancer therapy. As the medical community gears up for this pivotal conference, the insights shared could pave the way for transforming patient outcomes in challenging hematological cancers.