On November 4, 2026 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, along with Ryvu Therapeutics (WSE: RVU), reported that the first clinical data from the ongoing Phase II JASPIS-01 study (NCT06534437) of dapolsertib (MEN1703, SEL24) in patients with r/r aggressive B-NHL will be presented in a poster session at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, held December 12-15, 2026, in New Orleans, Louisiana, and virtually.
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Dapolsertib is a first-in-class oral dual PIM/FLT3 kinase inhibitor that has demonstrated preclinical antitumor activity and synergy with anti-CD20-directed therapies. The abstract reports the first clinical results from Group 2 of the JASPIS-01 study, which evaluates dapolsertib monotherapy (125 mg orally once daily on days 1-14 of 21-day cycles) in adults with r/r aggressive B-NHL who have exhausted available standard treatment options following at least two prior systemic therapies. Clinical activity was observed in heavily pretreated patients. The safety profile was manageable and allowed dosing of dapolsertib at the intended dose level.
"Patients with aggressive B-cell lymphoma whose disease progresses after CAR-T cell therapy and bispecific antibodies have limited treatment options and face very poor outcomes," said Elcin Barker Ergun, CEO of the Menarini Group. "The encouraging initial findings in heavily pretreated patients support the continued clinical development of dapolsertib, a first-in-class oral dual PIM/FLT3 inhibitor, as a potential option for this grim disease, and we look forward to further results from the ongoing study."
"We are very pleased that the first clinical data from JASPIS-01 will be presented at ASH (Free ASH Whitepaper), a leading hematology meeting. The activity seen in the JASPIS-01 study are particularly encouraging, given the highly aggressive biology of the disease in this population," said Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics. "As dapolsertib inventors and Menarini’s operational partner for the study, we remain committed to advancing dapolsertib for patients with aggressive B-cell lymphoma, who urgently need new treatment options."
Details on the poster presentation are as follows:
Poster Title: 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: Initial results from the Phase II JASPIS-01 trial
Publication Number: 3662
Session: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II
Session date and time: Sunday, December 13, 2026, 6:00-8:00 PM CST (1:00-3:00 AM CET on December 14)
Location: Ernest N. Morial Convention Center, Hall F, New Orleans, Louisiana
The abstract is available on the ASH (Free ASH Whitepaper) website: View Source
About JASPIS-01
JASPIS-01 (NCT06534437) is an ongoing multicenter, open-label Phase II study evaluating dapolsertib as monotherapy and in combination with glofitamab in adults with r/r aggressive B-NHL, including diffuse large B-cell lymphoma (DLBCL), after at least two prior systemic therapies. Group 1 evaluates dapolsertib in combination with glofitamab in patients naïve to CD3×CD20 bispecific antibodies. Group 2 evaluates dapolsertib as monotherapy in patients who have exhausted available standard treatment options. The primary endpoint is overall response rate (ORR) per the Lugano Classification; secondary endpoints include duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety.
About dapolsertib
Dapolsertib (MEN1703, SEL24) is a first-in-class, oral, selective small-molecule dual inhibitor of PIM and FLT3 kinases, discovered by Ryvu. Global development and commercial rights to dapolsertib are licensed to the Menarini Group. Since September 2023, Ryvu has been Menarini’s operational partner for Phase II study execution, with Menarini funding all research and development costs. Dapolsertib is an investigational agent and has not been approved by any regulatory authority.
(Press release, Menarini, NOV 4, 2026, View Source [SID1234674220])