Frontline Ibrutinib/Venetoclax Generates Prolonged uMRD Data in CLL

Carolyn Owen, MD, associate professor in the Division of Hematology & Hematological Malignancies, University of Calgary, and hematologist at the Tom Baker Cancer Center, discusses data from the phase 3 GLOW study (NCT03462719) which were presented at the 10th Annual Meeting of the Society of Hematologic Oncology (SOHO).

The GLOW study enrolled patients aged 65 years or older or 18-64 years with chronic lymphocytic leukemia (CLL) and randomized them in a 1:1 ratio to receive either 3 cycles of ibrutinib (Imbruvica) followed by venetoclax (Venclexta) for 12 cycles or 6 cycles of chlorambucil and obinutuzumab (Gazyva). The primary end points were progression-free survival and undetectable minimal residual disease (uMRD).

According to Owen, data from the trial showed that elderly or unfit patients with CLL who were given frontline treatment with fixed-duration ibrutinib and venetoclax had deeper and prolonged uMRD responses vs those given chlorambucil and obinutuzumab.

TRANSCRIPTION:

0:08 | The primary end points of the study were independent review committee-assessed progression free survival, and those results were presented about a year ago with a 20 month median follow-up, and it strongly favors the IV over the chlorambucil obinutuzumab. Not many people were surprised by that result. To date, there's still no overall survival advantage. There have been a few extra deaths in the chlorambucil obinutuzumab group, but no extra deaths in the IV groups and maybe with time, we might move to seeing an overall survival difference.

0:40 | The presentation at SOHO [was] directed towards the MRD results, which are a secondary end point of the study, it's very interesting to see that MRD, now, isn't predictive of outcome. That is probably just because there are so few progressions in the IV therapy group. We probably need to watch that group for a lot longer.

1:03 | I think that these results from the GLOW study, not the MRD results particularly, but the study in general and the progression-free survival results are valuable in showing us that I plus V or any novel oral combination is a highly effective therapy, fairly well-tolerated, and it would be a desirable and effective option for many patients with CLL.