Trial results showing improved overall survival with a combination of azacitidine and venetoclax may prompt a change how clinicians approach treatment in older adults newly diagnosed with acute myeloid leukaemia (AML).
Results from the VIALE-A trial presented at the European Hematology Association virtual congress (EHA25) showed that the combination of azacitidine and venetoclax was associated with improved overall survival (14.7 vs 9.6 months) in patients ineligible for intensive therapy compared with the use of azacitadine plus a placebo.
The data from 431 patients taking part in the Phase III international trial also showed improved response rates with complete remission (or complete remission with incomplete count recovery) in 66% patients taking the combination treatment compared with 28% on azacitidine alone.
Researchers from MD Anderson Cancer Center in Texas told the virtual meeting that the combination treatment was also associated with quicker responses with a median time to response of 1.3 months, and more durable response lasting 1.5 years.
They concluded that “this practice-changing multicentre randomised Phase III trial establishes venetoclax and azacitidine as a new standard of care for older patients with AML”.
Professor Nigel Russell, Consultant Haematologist at Guy’s Hospital NHS Trust and Emeritus Professor of Haematology at Nottingham University said the VIALE-A trial results were important for older patients, usually over the age of 65, who would not be suitable for intensive therapy because of their age and other co-morbidities.
“The treatment of these patients has generally been very unsatisfactory. Azacitidine is not approved by NICE for many patients and the results are disappointing anyway with survival limited to a few months whatever you use, so this is an area of unmet need.”
He added that the results showed a significantly better response and survival from the combination treatment with evidence of some patients having a long-term benefit.
“So this really is a practice changing combination and it will, given time, become the standard of care.
“It will have to get approval in Europe and go through NICE but this combination does look like it significantly improves the outcome for a number of patients and the sooner it can get approval the better.”
He added that it was possible that the results could be improved further by adding in other agents. “It may be this will improve even further over time.”