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First Clinical Data Release for Dapolsertib in Aggressive B-cell Non-Hodgkin Lymphoma

On December 13, 2026, groundbreaking initial clinical data from the JASPIS-01 Phase II study evaluating Dapolsertib (MEN1703, SEL24) was presented during the 68th Annual Meeting and Exposition of the American Society of Hematology (ASH) in New Orleans, Louisiana. This study, conducted by Menarini Group and Ryvu Therapeutics, focuses on Dapolsertib’s efficacy in heavily pretreated patients suffering from relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL).

Dapolsertib is recognized as a first-in-class oral dual inhibitor of PIM and FLT3 kinases, designed to address unmet needs in patients experiencing limited therapeutic options after exhausting standard treatments. Recent clinical observations reported that patients in this study had undergone a median of four prior treatment lines, with more than half having received CAR-T therapy and nearly 60% having been treated with bispecific CD3×CD20 antibodies.

Clinical Study Overview

The JASPIS-01 study is a multicenter, open-label Phase II clinical trial aimed at assessing the monotherapy of Dapolsertib in adults afflicted with relapsed or refractory aggressive B-NHL, who had traversed through at least two prior systemic therapies. The study currently classifies patients into two groups: Group 1, which explores the combination of Dapolsertib with Glofitamab, and Group 2, which investigates Dapolsertib as a solo treatment method.

Data presented showcased encouraging clinical activity in heavily pretreated subjects, highlighting the necessity of innovative treatment strategies in a patient demographic challenged by poor prognoses following CAR-T and bispecific antibody therapies. The safety profile of Dapolsertib was found to be manageable, allowing the administration of the drug at its intended dose.

Implications of Findings

Elcin Barker Ergun, CEO of Menarini Group, emphasized the critical need for novel treatments in this patient population. “Patients with aggressive B-cell lymphoma see few options remain after progression post CAR-T and bispecific antibody therapy,” he stated. The preliminary results underscore Dapolsertib's potential as a viable treatment avenue, urging for its continued clinical evaluation.

Dr. Hendrik Nogai, Chief Medical Officer of Ryvu Therapeutics, echoed these sentiments. “We are pleased to have our initial data presented at ASH, a leading conference in hematology. The efficacy observed in the JASPIS-01 study is particularly encouraging given the highly aggressive pathology in this patient group.”

Conference Presentation Details

The presentation of this research was accompanied by a dedicated poster titled: Preliminary clinical activity and safety of dapolsertib (MEN1703), a first-in-class dual PIM/FLT3 inhibitor, in heavily pretreated relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. This session took place in the Ernest N. Morial Convention Center in New Orleans, providing an excellent platform for sharing innovative hematologic treatment advances.

Future Directions

Moving forward, the JASPIS-01 study underscores the importance of developing targeted therapies that address the needs of underserved patient populations. As this study progresses, focus will remain on evaluating overall response rates (ORR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety metrics associated with Dapolsertib.

The ongoing collaboration between Menarini and Ryvu Therapeutics exemplifies the shared commitment to advancing oncological therapies for patients desperate for new solutions. As researchers eagerly await further data, the hope is that Dapolsertib could transform treatment paradigms for those suffering from aggressive B-cell non-Hodgkin lymphoma, paving the way for a brighter future in clinical oncology.