Enrico Tiacci, MD, discusses updated data of a phase II trial investigating the combination of vemurafenib and rituximab for patients with relapsed/refractory hairy cell leukemia.
Enrico Tiacci, MD, associate professor of hematology, University and Hospital of Perugia, Italy, discusses updated data of a phase II trial (EudraCT 2014-003046-27) investigating the combination of vemurafenib (Zelboraf) and rituximab (Rituxan) for patients with relapsed/refractory hairy cell leukemia.
The trial enrolled 31 patients previously treated with purine analogs to receive 8 weeks of 960 mg of vemurafenib twice daily followed by concomitant 375 mg/m2 of intravenous rituximab every 2 weeks. Consolidation rituximab was given 4 times every 2 weeks after stopping vemurafenib.
Notably, of the 27 evaluable patients, 26 achieved a complete remission (CR). Additionally, 65% of patients had minimal residual disease (MRD) negativity after treatment.
Progression-free survival (PFS) was 100% after a median of 30.5 months for the patients who obtained a MRD-negative CR. Patients who were MRD-positive following treatment had a median PFS of 24.5 months.
Further follow-up will be conducted in this patient cohort, but these results appear promising, concludes Tiacci.