#USA #New Orleans #Menarini #Dapolsertib #Ryvu

Clinical Breakthroughs in Aggressive B-Cell Lymphoma

In a significant advancement for patients battling aggressive B-cell non-Hodgkin lymphoma (B-NHL), the Menarini Group and Ryvu Therapeutics have announced initial clinical data from their Phase II JASPIS-01 study at the 68th American Society of Hematology (ASH) Annual Meeting. This exciting data, revealing the efficacy of dapolsertib (MEN1703, SEL24), a pioneering oral dual PIM/FLT3 kinase inhibitor, could represent a beacon of hope for those with relapsed or refractory cases of this challenging lymphoma.

The Study: Overview and Objectives

The Phase II JASPIS-01 study, now available for review, investigates the monotherapy effects of dapolsertib in patients who have faced multiple treatment challenges. Specifically, it targets adults with relapsed/refractory aggressive B-NHL who have undergone a median of four prior lines of therapy. Notably, 53% of the enrolled patients had previously been treated with CAR-T cell therapy while 60% had utilized CD3×CD20 bispecific antibodies. This population represents a critical area of need due to their severely limited treatment options and historically poor clinical outcomes.

Efficacy and Safety Findings

Preliminary results unveiled at ASH indicate a notable clinical activity among the heavily pretreated participants. With a strategic dosing regimen of dapolsertib at 125 mg taken orally once daily for two weeks, the study demonstrated promising initial outcomes, marking it as a potential new option for patients with advanced disease. The safety of the drug appeared manageable, allowing continuation at the intended dose levels.

Elcin Barker Ergun, the CEO of Menarini Group, expressed optimism regarding these findings, emphasizing the unmet medical need in this patient demographic: "Patients with aggressive B-cell lymphoma, whose disease continues to progress after CAR-T therapy and bispecific antibodies, have historically faced grim outlooks. The encouraging results signal the importance of further developing dapolsertib as a viable option for such cases."

Future Directions

The presentation at ASH provides a platform for greater awareness of the necessity for innovative treatments for this complex disease. The findings showcased the potential for dapolsertib to make a meaningful difference in the lives of patients whose conditions have proven unresponsive to existing therapies.

Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics, remarked, "Presenting the first clinical data at ASH is a milestone for us. The activity noted in this trial supports our commitment to advancing dapolsertib as a crucial treatment for patients in dire need of new therapeutic options."

Event Details

The data from the JASPIS-01 study will be presented on December 13, 2026, at the ASH Annual Meeting in New Orleans, Louisiana. Attendees can find further details about the study through the abstract available on the ASH website.

Conclusion

As the medical community anticipates the ASH meeting, the unveiling of these promising results for dapolsertib sets a positive tone for future oncology treatments. The ongoing work of Menarini Group and Ryvu Therapeutics reinforces the importance of collaborative efforts in addressing unmet needs within the realm of aggressive hematological malignancies.

Continuous research and clinical trials will be pivotal in determining the long-term implications and effectiveness of dapolsertib, especially as it is further evaluated within the diverse landscape of lymphoma therapies.