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Menarini and Ryvu Therapeutics Present Initial Data on dapolsertib in Phase II Study

In a recent announcement, Menarini Group and Ryvu Therapeutics have unveiled compelling initial clinical data from the Phase II JASPIS-01 study of dapolsertib (MEN1703) at the annual meeting of the American Society of Hematology (ASH) 2026. This study focuses on the effectiveness of dapolsertib in patients suffering from aggressive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).

The results presented indicate that dapolsertib, an oral dual PIM/FLT3 kinase inhibitor, has shown promising clinical activity among a demographic of heavily pretreated patients. The majority of these participants had previously undergone multiple lines of therapies, with 53% having already received CAR-T cell therapy and 60% having been treated with bispecific antibodies targeting CD3×CD20.

Currently, the therapeutic options for patients experiencing disease progression after CAR-T therapy and/or bispecific monoclonal antibodies are severely limited. This clearly underscores the critical demand for new, effective treatment modalities within this challenging patient population.

The exciting data will be showcased on December 13, 2026, during an in-person poster presentation at the 68th ASH Annual Meeting taking place in New Orleans, Louisiana. Observations from the study reflect an encouraging profile of efficacy and safety for dapolsertib, suggesting its potential viability as a treatment option.

The Phase II JASPIS-01 Study: An Overview

JASPIS-01 is a multicenter, open-label Phase II clinical trial examining the single-agent efficacy of dapolsertib for adult patients with aggressive B-NHL who have exhausted available standard treatment options after at least two prior therapies. Specifically, the study evaluates dapolsertib's ability to produce a clinical response in heavily pretreated patients, demonstrating ongoing clinical activity even in such advanced settings.

The drug is administered at a daily oral dose of 125 mg for the first 14 days in each 21-day cycle. Results from the 2nd group of participants within this study were met with optimism, reflecting satisfactory safety profiles that support ongoing clinical investigations.

Elcin Barker Ergun, CEO of Menarini, expressed, "Patients diagnosed with aggressive B-cell lymphomas face dire outcomes after exhausting CAR-T therapies and bispecific monoclonal antibodies. The encouraging preliminary results from heavily pretreated patients reinforce our commitment to advancing dapolsertib as a potential therapeutic option for these serious conditions, and we eagerly await further observations from the ongoing study."

Hendrik Nogai, Chief Medical Officer at Ryvu Therapeutics, also emphasized the significance of the findings, noting, "It is gratifying to witness initial data presented at ASH, a key congress in hematology. The clinical activity evident in this population – known for its aggressive disease biology – underscores our determination to enhance treatment alternatives for these individuals in urgent need of novel therapies."

Presentation Details at ASH 2026

The initial findings will be detailed in a poster presentation:

• - Poster Title: "Preliminary Clinical Activity and Safety of dapolsertib (MEN1703), a First-in-Class Dual PIM/FLT3 Inhibitor in Heavily Pretreated Aggressive B-Cell Non-Hodgkin Lymphoma"
• - Publication Number: 3662
• - Session: 627 - Aggressive Lymphomas
• - Date and Time: Sunday, December 13, 2026, from 6:00 PM to 8:00 PM CT
• - Location: Ernest N. Morial Convention Center, Hall F, New Orleans, Louisiana

This trial represents an important milestone for both Menarini and Ryvu as they continue to strategize on pushing forward with dapolsertib’s development within the oncology space. The landscape of treatment options for patients with advanced B-NHL is promising a transformation fueled by innovative therapies like dapolsertib.

Conclusion

As the urgency for effective treatments in hematological malignancies increases, dapolsertib's clinical data emerging from JASPIS-01 could play a pivotal role in reshaping future care pathways for patients battling aggressive forms of B-cell lymphoma. Stakeholders in the oncology community will closely watch these developments, further signaling the importance of ongoing research and clinical trials in advancing patient care.