CLL14 Trial: Paired With Obinutuzumab, Venetoclax Versus Chlorambucil in CLL
Posted: Friday, August 16, 2019
In the multinational phase III CLL14 clinical trial involving more than 400 patients with previously untreated chronic lymphocytic leukemia (CLL) and comorbidities, researchers found that a fixed-duration treatment regimen of targeted venetoclax plus obinutuzumab (VenG) yielded better progression-free survival rates and induced “long-lasting” minimal residual disease (MRD) negativity rates than those achieved with chlorambucil plus obinutuzumab (ClbG). Kirsten Fischer, MD, of the University Hospital in Cologne, Germany, presented her team’s findings at the 24th European Hematology Association (EHA) Congress in Amsterdam (Abstract S149) and published them in The New England Journal of Medicine.
The open-label trial included 216 patients (median age, 72 years) in each arm. All had a Cumulative Index Rating Score greater than 6 and/or an estimated creatinine clearance less than 70 mL/min. The patients received 12 cycles of either venetoclax or chlorambucil, for the first 6 cycles, in combination with obinutuzumab.
“The VenG arm had a low rate of conversion to MRD-positive status 1 year after treatment, translating into improved progression-free survival,” the primary endpoint, Dr. Fischer and colleagues noted. Although a median progression-free survival was not reached after a median of 29 months of follow-up in either group, progression-free survival at the 24-month mark was 88% with VenG and 64% with ClbG (P < .0001).
The team reported that 3 months after treatment completion, MRD negativity (as measured by allele-specific oligonucleotide polymerase chain reaction assay) was significantly higher with VenG than ClbG in both peripheral blood (76% vs. 35%; P < .0001) and bone marrow (57% vs. 17%; P < .0001). Of note, MRD negativity was also more sustainable with VenG. Twelve months after completing treatment, 81% of patients in the VenG arm compared with 27% in the ClbG arm were MRD-negative.
Disclosure: The study authors’ disclosure information may be found at ehaweb.org.
