Medically reviewed by Dr. Brian Koffman
The treatment landscape for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) has changed dramatically in the past decade. New targeted therapies have revolutionized CLL / SLL treatment and significantly improved patient outcomes. In this interview, Dr. Brian Koffman spoke with Dr. Lori Leslie, a lymphoma and CLL specialist at the John Theurer Cancer Center in Hackensack, New Jersey. They discussed a new phase 3 clinical trial that tests sonrotoclax, a new BCL2 inhibitor, combined with zanubrutinib for CLL.
What is sonrotoclax?
Sonrotoclax is a BCL2 inhibitor. It belongs to the same class of drugs as venetoclax. BCL2 is an overexpressed protein in CLL cells, allowing them to survive much longer than normal white blood cells.
Where is sonrotoclax in the drug development process?
Sonrotoclax is not FDA approved yet. It is still being tested in clinical trials.
What clinical trials using sonrotoclax are available for patients with CLL?
A study that is ongoing and currently recruiting patients is the Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL). The trial has been named CELESTIAL-CLLTN.
This study is a phase 3, multicenter, international, randomized clinical trial testing the combination of sonrotoclax plus zanubrutinib compared with venetoclax plus obinutuzumab. Both zanubrutinib and venetoclax plus obinutuzumab are very effective treatments in their own right. Both treatments are time-limited to about one year.
The trial’s primary outcome is progression-free survival, which will take several years to determine. Investigators will also examine secondary outcomes, such as undetectable minimal residual disease, that will hopefully give them an earlier indication of efficacy.
Who can participate in this CLL study?
To participate, patients should have untreated CLL. Other conditions are okay as long as they are well-controlled. Patients with Richter’s transformation are not eligible for this study. In this trial, the cost of drugs for the experimental arm and the standard of care (comparator) arm will be covered for patients.
Study sites continue to open across the United States, Canada, Australia, and New Zealand, and more detailed information can be found on the study’s ClinicalTrials.gov listing.
Any final thoughts?
In this new era of targeted therapies, there are a lot of good options for treating CLL. It is important to talk to your doctor about what therapy they recommend and why they recommend that particular one over other available therapies. Clinical trials are another important tool to consider along the way, and they provide more options for patients. This particular trial offers patients strong options in both arms in its bold design to compare the new therapy combination of sonrotoclax plus zanubrutinib against the excellent results seen with the approved combination of venetoclax and obinutuzumab.
Links and Resources:
Watch the interview here:
Take care of yourself first.
Ann Liu, PhD