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Getting the latest healthcare news for you
A phase 2 trial found that azacitidine plus venetoclax more than doubled event-free survival compared to standard induction chemotherapy in fit patients with newly diagnosed AML. The combo also led to fewer serious side effects and higher rates of patients reaching transplant. The findings could reshape how frontline AML treatment is approached.
For decades, intensive induction chemotherapy has been the go-to first-line treatment for patients with acute myeloid leukemia (AML) who are fit enough to handle it. But a new phase 2 trial — the PARADIGM study — is challenging that standard, showing that a less-intensive regimen of azacitidine plus venetoclax significantly outperforms traditional chemo in certain patients.
Published in The New England Journal of Medicine, the trial enrolled 172 adults with previously untreated AML who were eligible for induction chemotherapy. Patients were randomized to receive either azacitidine-venetoclax or standard induction chemo (7+3 or CPX-351). The results were striking: the azacitidine-venetoclax group had more than double the median event-free survival and a higher rate of proceeding to hematopoietic cell transplantation — all with fewer serious complications.
Why it matters: These findings support a potential shift in frontline AML treatment — particularly for patients with nonfavorable-risk, FLT3-nonmutated disease. A less-intensive approach can mean fewer hospitalizations, fewer serious complications, and better long-term outcomes, offering a meaningful quality-of-life advantage without sacrificing efficacy.
