By Reuters Staff
(Reuters Health) - 4/6/2019
Among patients with chronic lymphocytic leukemia (CLL) and coexisting conditions such as heart, lung or digestive disease, adding venetoclax to obinutuzumab therapy produces longer progression-free survival than adding chlorambucil, newly-published results of the CLL14 trial have concluded.
The open-label phase 3 trial of 432 volunteers found that after a median of 28.1 months, disease progression or death occurred in 30 of the 216 venetoclax recipients versus 77 of the CLL patients treated with chlorambucil (P<0.001).
The rate of progression-free survival at 24 months was 88.2% with venetoclax versus 64.1% with chlorambucil, researchers reported at the American Society of Clinical Oncology's annual meeting in Chicago and online in The New England Journal of Medicine.
In addition, three months after treatment completion, 56.9% of venetoclax recipients had no residual disease in the bone marrow versus 17.1% of patients in the chlorambucil.
However, the rate of all-cause mortality was not significantly different.
Roche and AbbVie, which developed venetoclax, which is sold under the brand name Venclexta, paid for the study.
Based on the findings, the U.S. Food and Drug Administration last month approved the venetoclax and obinutuzumab (Gazyva) combination for previously-untreated patients with CLL and for small lymphocytic lymphoma.
The dual therapy was associated with neutropenia in 60% of recipients, diarrhea in 28%, fatigue in 21%, nausea in 19%, anemia in 17% and an upper respiratory tract infection in 17%, according to a news release from AbbVie.
Coexisting conditions are an issue because most people who develop CLL are over 70, when the rate of other health problems can be high.
Investigators in the CLL14 study used patients with previously-untreated CD20+ CLL. The volunteers also needed to have a score greater than 6 on the 57-point Cumulative Illness Rating Score. They could also be enrolled if they had a creatinine clearance of less than 70 ml/min.
Researchers at 196 sites in 21 countries participated in the trial. Patients were treated for a dozen 28-day cycles.
N Engl J Med 2019