Minimal residual disease testing is quickly moving from research to routine care in chronic lymphocytic leukemia. Julie M. Vose, MD, MBA, made this clear at the SOHO 2026 Annual Meeting. She showed how MRD testing is now part of real-world decisions. Time-limited therapies are becoming the new normal for both doctors and patients dealing with CLL.
The FDA issued a class-wide boxed warning for all six approved CAR-T cell therapies in April 2024, highlighting the rare but notable risk of secondary T-cell malignancies.
The meeting’s strongest warning came from Jasmine M. Zain, MD. She broke down the often-overlooked risk of secondary lymphoma after CAR T-cell therapy. Zain went beyond just counting cases. She explained the difference between cancers caused by retroviral or lentiviral insertion and those that come from years of genotoxic stress. For doctors, this means they need to watch patients closely even after remission. They must tell the difference between these risks to guide follow-up and treatment.
The FDA first introduced a class warning on T-cell malignancies for CAR-T therapies in November 2023, later mandating boxed warnings for all approved products in April 2024. This regulatory action was based on emerging safety data and aims to ensure clinicians and patients are aware of the rare but serious risks associated with CAR-T treatment.
At the same time, new hope is emerging for myelodysplastic syndrome. Fresh results from the phase 2a HT-6184-MDS-001 trial were shared. David Sallman, MD, explained how ofirnoflast (HT-6184), a first-in-class oral allosteric NEK7 inhibitor, was tested in lower-risk MDS patients who could not use or did not respond to erythropoiesis-stimulating agents. The trial showed platelet and neutrophil responses with an on-and-off oral dosing schedule. This could help keep quality of life up, especially for older patients with other health problems who cannot handle harsher treatments.
Ofirnoflast’s progress picked up speed when the FDA gave it Fast Track status in June 2026, right after final phase II data came out in May. This puts ofirnoflast at the front of new options for lower-risk MDS, as noted in a recent OncLive market update.
SOHO 2026 did not offer simple solutions. But the message was clear: blood cancer care is changing. Doctors are now using sharper risk tools, smarter trial designs, and focusing more on what matters to patients. MRD-guided therapy, a better grasp of treatment risks, and new drugs like ofirnoflast are pushing the field past old one-size-fits-all approaches. The next step is to bring these advances into daily care, while still dealing with the tough realities of blood cancer.
