Othman Al-Sawaf, MD, discusses updated data from the phase 3 CLL14 trial in chronic lymphocytic leukemia.
Othman Al-Sawaf, MD, physician, University Hospital of Cologne, Cologne, Germany, discusses updated data from the phase 3 CLL14 trial in chronic lymphocytic leukemia (CLL).
The multicenter, open-label, randomized CLL14 trial enrolled patients with previously untreated CLL. Patients were randomized to either venetoclax (Venclexta) plus obinutuzumab (Gazyva) or chlorambucil plus obinutuzumab.
The first main finding from the study presented at the 2020 ASCO Virtual Scientific Program was that there was a sustained and significant progression-free survival (PFS) benefit for patients treated with venetoclax plus obinutuzumab, says Al-Sawaf. With 3 year follow-up, results showed a PFS rate of 81.9% in patients treated with venetoclax plus obinutuzumab versus 49.5% in patients treated with chlorambucil plus obinutuzumab.
All risk groups and patients with TP53 aberrations and unmutated IGHV status saw a benefit with venetoclax plus obinutuzumab, but the benefit with the combination was higher in patients with mutated IGHV status, Al-Sawaf adds. The difference observed in the primary analysis was in patients who were treated with chemoimmunotherapy and had a favorable PFS when they had mutated IGHV status; this has been a group that has always benefited from chemoimmunotherapy, says Al-Sawaf.
With this follow-up analysis, venetoclax plus obinutuzumab has also been found to improve outcomes in this particular subgroup of patients, and therefore, all patients of all risk groups benefit from the regimen, concludes Al-Sawaf.