Menarini Group, an internationally reach pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. («Stemline») —a 100% owned subsidiary of Menarini specialized in innovative oncology treatments—, along with Ryvu Therapeutics (WSE: RVU), have announced that the first clinical results of the phase II trial JASPIS-01 (NCT06534437) with dapolsertib (MEN1703, SEL24) in adult patients with aggressive relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL), will be presented in a poster session during the 68th Annual Meeting and Exposition of the American Society of Hematology (ASH). The conference will be held from December 12 to 15, 2026 in New Orleans, Louisiana, in a in-person and virtual format.
Dapolsertib is a dual oral PIM/FLT3 kinase inhibitor —the first in its class— that has shown antitumor activity in preclinical models, as well as synergy with targeted therapies against the CD20 antigen. The abstract includes the first clinical data from Group 2 of the JASPIS-01 trial, in which dapolsertib is studied as monotherapy (125 mg by mouth, once daily, from day 1 to 14 in 21-day cycles) in patients with aggressive relapsed or refractory B-NHL who have exhausted standard treatment alternatives after having received at least two prior systemic lines. Clinical activity was observed in heavily pretreated patients. The safety profile was considered manageable and allowed the planned dose of dapolsertib to be maintained.
«Patients with aggressive B-cell lymphoma whose disease progresses after receiving therapy with CAR-T cells and bispecific antibodies have limited treatment options and face a very unfavorable prognosis,» said Elcin Barker Ergun, CEO of the Menarini Group. «The encouraging initial results observed in patients who have received multiple prior treatments support the continuation of the clinical development of dapolsertib —a dual oral PIM/FLT3 inhibitor, first in its class— as a possible option against this serious disease; we look forward to learning the next results from the ongoing study.»
«We are extremely pleased that the first clinical data from the JASPIS-01 study are being presented at the ASH, a reference congress in the field of hematology. The activity observed in the JASPIS-01 study is especially encouraging, given the highly aggressive biology of the disease in this population», said Dr. Hendrik Nogai, medical director of Ryvu Therapeutics. «As inventors of dapolsertib and operational partners of Menarini in this study, we maintain our commitment to continue moving forward in the development of dapolsertib for patients with aggressive B-cell lymphoma, who urgently need new therapeutic options».
Poster presentation at the ASH congress
The poster will be entitled: "Preliminary clinical activity and safety of dapolsertib (MEN1703), a dual inhibitor of PIM/FLT3 (first-in-class), in patients with aggressive B-cell non-Hodgkin lymphoma, in relapse or refractory disease, and with multiple prior treatments: initial results from the phase II JASPIS-01 trial". The assigned publication number is 3662 and it falls under the session "627. Aggressive lymphomas: targeted and pharmacological therapies: Poster II".
The poster session is scheduled for Sunday, December 13, 2026, from 18:00 to 20:00 h CST (from 01:00 to 03:00 h CET on December 14), at the Ernest N. Morial Convention Center, Hall F, in New Orleans, Louisiana. The abstract can be viewed on the ASH website: https://www.hematology.org/meetings/annual-meeting.
About the JASPIS-01 study
JASPIS--01 (NCT06534437) is an ongoing, currently running, multicenter, open-label phase II trial that evaluates dapolsertib both as monotherapy and in combination with glofitamab in adults with aggressive B-cell non-Hodgkin lymphoma (B-NHL), relapsed or refractory —including diffuse large B-cell lymphoma (DLBCL)—, after a minimum of two prior systemic treatments. Group 1 studies dapolsertib in combination with glofitamab in patients without prior exposure to CD3×CD20 bispecific antibodies, while Group 2 investigates dapolsertib as monotherapy in patients who no longer have standard options available. The primary endpoint is the overall response rate (ORR) according to the Lugano classification, and among the secondary endpoints are the duration of response (DR), progression-free survival (PFS), overall survival (OS), and safety.
About dapolsertib
Dapolsertib (MEN1703, SEL24) is a dual small-molecule inhibitor, selective and orally administered, directed against PIM and FLT3 kinases, discovered by Ryvu and considered a pioneering drug in its class. The global development and commercialization rights for dapolsertib have been licensed to Grupo Menarini. Since September 2023, Ryvu has been acting as Menarini’s operating partner for the Phase II trial, while Menarini fully funds the research and development costs. Dapolsertib is an investigational agent and still does not have approval from any regulatory authority.
About Grupo Menarini
Grupo Menarini is an internationally reference pharmaceutical and diagnostics company, with revenues of 5.5 billion dollars and a workforce of more than 17,000 people. The company focuses on therapeutic areas with high unmet medical needs and commercializes treatments in cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetology, inflammation and analgesia. It has 18 production plants and 9 research and development centers, and its products are distributed in 140 countries. More information at www.menarini.com.
About Stemline Therapeutics Inc.
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