Ryvu Reports Early Dapolsertib Data in Phase II Lymphoma Trial

Ryvu Therapeutics and Menarini Group announced on November 4, 2026 the first clinical data from the Phase II JASPIS-01 study of dapolsertib monotherapy in relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: four of the 15 patients treated by the data cutoff experienced clinical benefit, including one complete response.

The analysis uses a June 18, 2026 data cutoff, and enrollment is continuing. The small number of treated patients and ongoing recruitment make this an initial snapshot rather than a final study analysis.

Early Activity After Extensive Prior Treatment

The cohort had a median of four prior lines of therapy; 53% of patients had received CAR-T cell therapy and 60% had received CD3×CD20 bispecific antibodies. Those details establish the extent of prior treatment in a study enrolling adults who had exhausted available standard options after at least two earlier systemic therapies.

Menarini CEO Elcin Barker Ergun said, “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.”

Ryvu described the safety profile as manageable, reported no new safety signal and said it allowed dapolsertib to be administered at the intended dose level.

What JASPIS-01 Is Designed to Measure

JASPIS-01 is an ongoing multicenter, open-label Phase II study in adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma. Group 2 evaluates 125 mg of oral dapolsertib once daily on days 1–14 of 21-day cycles. Group 1 separately evaluates dapolsertib with glofitamab in patients who have not previously received CD3×CD20 bispecific antibodies.

The primary endpoint is overall response rate under the Lugano Classification. Secondary endpoints include duration of response, progression-free survival, overall survival and safety. The announcement does not provide a final overall response rate, and its “clinical benefit” wording should not be read as four objective responses.

Ryvu characterizes dapolsertib as a first-in-class oral, selective small-molecule dual inhibitor of PIM and FLT3 kinases. The company also reports preclinical antitumor activity and synergy with anti-CD20-directed therapies, providing a rationale for further clinical development rather than evidence of clinical efficacy.

Menarini Funds the Program

Menarini holds the global development and commercial rights to dapolsertib under license from Ryvu. Ryvu has served as Menarini’s operational partner for Phase II execution since September 2023, while Menarini funds all research and development costs. The arrangement places trial execution with the drug’s discoverer and development spending with its licensee.

Dapolsertib remains investigational and has not been approved by any regulatory authority. Beyond lymphoma, Menarini’s announcement says a separate Phase II study in myelofibrosis, SPHENE-01, is planned to start in the first quarter of 2027.

ASH released the 2026 meeting abstracts online at 9:00 a.m. Eastern time on November 4. The dapolsertib poster is scheduled for December 13, 2026, during the December 12–15 meeting and may contain additional and updated information.

The immediate development question is whether continued enrollment produces a larger response dataset and evidence of durability. For now, the disclosure establishes preliminary activity in a small, heavily pretreated population; the formal response-rate, response-duration and survival endpoints remain the measures against which that early signal must be assessed.