AbbVie and Roche have announced data from the CLL14 trial, evaluating Venclyxto (venetoclax) plus Gazyvaro (obinutuzumab) in patients with previously untreated chronic lymphocytic leukemia.

The pivotal phase III study met its primary endpoint of investigator-assessed progression-free survival (PFS), with the 12-month, fixed-duration combination reducing the risk of disease worsening or death by 65% compared to Gazyvaro plus chlorambucil.

After a median follow-up of 28 months, results showed that patients who received the chemotherapy-free combination achieved an overall response rate of 84.7% vs. 71.3%, and at two years, one year after stopping treatment, nearly nine out of 10 - 88.2% - patients in the combo arm remained progression-free, compared to 64.1% in the Gazyvaro plus chlorambucil arm.

“The results of our phase III CLL14 trial, reported today at ASCO and in the New England Journal of Medicine, represent a major advance in improving outcomes in chronic lymphocytic leukaemia,” said Sandra Horning, Roche’s chief medical officer and head of global product development.

She continued, “We are pleased this fixed-duration, chemotherapy-free regimen of Venclyxto plus Gazyvaro was approved by the FDA and look forward to providing an important treatment option to even more adults with the most common form of adult leukaemia.”

Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. The drug then blocks the BCL-2 protein and works to restore the process of apoptosis.

The results were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).