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Menarini Group and Ryvu Therapeutics Present Initial Results of JASPIS-01 Study on Dapolsertib

El Grupo Menarini, a prominent pharmaceutical and diagnostics leader, alongside Ryvu Therapeutics, has recently disclosed preliminary clinical data from their Phase II study JASPIS-01, focusing on the novel treatment dapolsertib (MEN1703, SEL24). This significant announcement was made during the 68th Annual Meeting and Exposition of the American Society of Hematology (ASH) 2026, which took place from December 12 to December 15 in New Orleans, Louisiana.

Overview of JASPIS-01 Study

The JASPIS-01 trial is a multicenter and open-label study designed to evaluate the effectiveness of dapolsertib in adult patients suffering from aggressive relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) who have exhausted previous treatment options. This cohort is particularly crucial because they often confront a dire prognosis, with very limited alternatives following multiple rounds of therapy.

Dapolsertib is a first-in-class oral inhibitor targeting PIM and FLT3 kinases, showing promising anti-tumor activity in preclinical studies and demonstrating synergy with therapies designed to target the CD20 antigen. The study aims to offer new hope to patients with aggressive forms of NHL who have undergone extensive treatments, including CAR-T cell therapy and bispecific antibody therapy.

Clinical Results

The latest data presented indicates significant clinical activity in patients with a history of extensive treatment—an average of four prior therapies. Notably, 53% of participants had previously undergone CAR-T therapy, while 60% had been treated with CD3×CD20 bispecific antibodies. These findings underscore the critical need for innovative treatment approaches in this population, particularly as they often face dismal outcomes post-CAR-T or bispecific therapy.

Elcin Barker Ergun, CEO of the Menarini Group, expressed optimism regarding the initial results, highlighting the urgent need for effective therapies for B-cell lymphoma patients with limited options. Similarly, Dr. Hendrik Nogai, Chief Medical Officer of Ryvu Therapeutics, reinforced the importance of the data shared, especially given the aggressive nature of the disease among the affected patients.

Poster Presentation Details

The exciting results from the trial will be formally presented in detail at a poster session on December 13, 2026, showcasing the safety and preliminary efficacy of dapolsertib. The poster, titled "Preliminary Clinical Activity and Safety of Dapolsertib (MEN1703), a First-in-Class Dual PIM/FLT3 Inhibitor in Patients with Aggressive Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma with Multiple Prior Treatments," will provide essential insights into the ongoing research and future development of this treatment.

Future Prospects

JASPIS-01 continues to emphasize the critical need for solutions in the treatment landscape of relapsed and refractory aggressive NHL. As the study progresses, the development of dapolsertib offers hope to patients who are otherwise left with few therapeutic options. The results herald a potential breakthrough in the care of patients struggling with this difficult-to-treat form of cancer.

With a strong commitment from both Menarini and Ryvu Therapeutics, the research teams are dedicated to advancing dapolsertib’s development, potentially transforming the therapeutic approaches available for patients affected by aggressive B-cell non-Hodgkin lymphoma.

Conclusion

In conclusion, the shared results from the JASPIS-01 study mark an important step forward in the battle against aggressive NHL. By presenting this data to the hematology community, Menarini and Ryvu Therapeutics pave the way for further exploration and ultimately hope to improve the outcomes for patients battling this challenging disease.