Dapolsertib shows initial clinical activity in heavily pretreated aggressive B-cell lymphoma in the Phase II JASPIS-01 study ahead of ASH 2026.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
Menarini Group, Stemline Therapeutics and Ryvu Therapeutics have announced initial clinical findings from the ongoing Phase II JASPIS-01 study of dapolsertib (MEN1703, SEL24) in adults with relapsed or refractory (R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL). The monotherapy cohort demonstrated clinical activity in a heavily pretreated population, although numerical efficacy and detailed safety results have not been disclosed in the announcement.
The findings will be presented at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, scheduled for December 12–15, 2026, in New Orleans, Louisiana, and virtually. The poster presentation is scheduled for December 13.
JASPIS-01 Evaluates Dapolsertib as Monotherapy and in Combination
Dapolsertib is an investigational, oral, selective small-molecule dual inhibitor of PIM and FLT3 kinases. Discovered by Ryvu Therapeutics, the compound has demonstrated preclinical antitumor activity and synergy with anti-CD20-directed therapies. Menarini Group holds global development and commercial rights to the drug.
The multicenter, open-label Phase II JASPIS-01 study (NCT06534437) evaluates dapolsertib in adults with R/R aggressive B-NHL, including diffuse large B-cell lymphoma (DLBCL), following at least two prior systemic therapies.
The study includes two treatment groups. Group 1 evaluates dapolsertib in combination with glofitamab in patients who have not previously received CD3×CD20 bispecific antibodies. Group 2 evaluates dapolsertib monotherapy in patients who have exhausted available standard treatment options.
The initial clinical findings concern Group 2, in which dapolsertib is administered at 125 mg orally once daily on Days 1–14 of each 21-day cycle.
Clinical Activity in a Heavily Pretreated Population
The companies reported clinical activity in patients receiving dapolsertib monotherapy. The population had a median of four previous lines of therapy, with 53% of patients previously exposed to CAR-T cell therapy and 60% treated with CD3×CD20 bispecific antibodies.
These treatment histories highlight the extent of prior treatment in the reported population. Patients whose disease progresses following CAR-T therapy or bispecific antibody treatment have limited subsequent therapeutic options, creating an important unmet need in aggressive B-cell lymphoma.
However, the announcement does not disclose the Group 2 sample size, the number of patients achieving an objective response or the numerical overall response rate (ORR). It also does not provide a data cutoff date. Consequently, the magnitude of the reported clinical activity cannot yet be quantified.
Safety and Clinical Endpoints
ORR, assessed according to the Lugano Classification, is the primary endpoint of JASPIS-01. Secondary endpoints include duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety.
The companies characterized the safety profile of dapolsertib monotherapy as manageable, allowing administration at the intended dose level. However, detailed adverse-event frequencies, severity grades, serious adverse events and treatment discontinuation rates were not disclosed.
The absence of numerical efficacy and detailed safety findings limits assessment of the treatment’s clinical benefit and tolerability at this stage.
Clinical Interpretation
The initial JASPIS-01 findings provide an early clinical activity signal for dapolsertib in a challenging R/R aggressive B-NHL population. Previous exposure to CAR-T therapy and CD3×CD20 bispecific antibodies in substantial proportions of patients makes this cohort particularly relevant to the search for additional treatment approaches after established therapies.
Dapolsertib’s dual PIM/FLT3 inhibition and preclinical activity provide the scientific rationale for its continued investigation. Nevertheless, the currently disclosed findings do not establish the magnitude or durability of clinical benefit. Numerical response rates, response duration, survival outcomes and comprehensive safety data will be necessary to determine its therapeutic potential.
The forthcoming ASH presentation is expected to provide further clinical details. Until these findings are available, dapolsertib remains an investigational treatment and should not be considered an established therapeutic option. The drug has not been approved by any regulatory authority.
Reference
Menarini Group and Ryvu Therapeutics Announce First Clinical Data from the Phase II JASPIS-01 Study of dapolsertib (MEN1703, SEL24) in Heavily Pretreated Relapsed/Refractory Aggressive B-cell non-Hodgkin Lymphoma at the 2026 ASH Annual Meeting, Menarini Group, 04 November 2026
MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01) (JASPIS-01), ClinicalTrials.gov ID NCT06534437
About the Writer
Kirti Kumbhar (LinkedIn) is an M.Pharm graduate with experience in Quality Assurance at Lupin Limited and a strong interest in clinical research, regulatory affairs, and Trial Master File (TMF) management. She has developed knowledge of regulatory documentation, quality systems, compliance, and healthcare research through her professional experience. Passionate about clinical development and continuous learning, Kirti is committed to supporting high-quality healthcare documentation, regulatory excellence, and research-driven healthcare advancements.