Double-hit lymphoma is highly aggressive and is associated with poor outcomes after standard chemoimmunotherapy.Adding the BCL2 inhibitor venetoclax to dose-adjusted EPOCH-R led to worse outcomes and excess mortality in patients with newly diagnosed double-hit lymphoma in a randomized trial.The excess mortality observed with added venetoclax -- six deaths versus one death in the DA-EPOCH-R group -- prompted early closure of the trial.

Adding the BCL2 inhibitor venetoclax (Venclexta) to chemoimmunotherapy led to worse outcomes and excess mortality in patients with newly diagnosed double-hit lymphoma, phase II results from a randomized trial showed.

Median progression-free survival (PFS) was 28.4 months in patients who received dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) versus 7.7 months in those who received the chemoimmunotherapy regimen plus venetoclax (HR 1.13, 95% CI 0.53-2.37, P=0.75), reported Jeremy S. Abramson, MD, of the Mass General Brigham Cancer Institute in Boston, and colleagues.

Median overall survival has not been reached in either group, and the 24-month overall survival estimates were 72% in the DA-EPOCH-R group compared with 52% in the group that received added venetoclax (HR 2.49, 95% CI 1.03-6.04, P=0.038), they noted in Lancet Haematology.