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Clinical Trial Will Evaluate Novel 3-Drug Regimen for First-Line Treatment of CLL

Web Exclusives — May 27, 2020

Targeted agents are important treatment options for patients with chronic lymphocytic leukemia (CLL). Examples of targeted treatments for the disease include ibrutinib (Imbruvica), an inhibitor of Bruton tyrosine kinase; venetoclax (Venclexta), a B-cell lymphoma-2 protein inhibitor; and obinutuzumab (Gazyva), an anti-CD20 monoclonal antibody.1 These have been shown to be effective in reducing disease burden in patients with CLL when given as single-agent therapy (also known as monotherapy).1

Cancer specialists want to know whether combining these 3 agents can lead to greater efficacy in the treatment of patients with CLL. This triplet regimen is being investigated in a phase 3 clinical trial called Alliance A041702, which is currently enrolling patients in more than 730 locations around the world.1,2

“The idea is to combine drugs with different targets and different mechanisms of action to achieve the highest response rates,” according to Michael J. Thirman, MD, Associate Professor, Medicine, University of Chicago Medicine, IL, and Principal Investigator of Alliance A041702.1

The trial will include approximately 450 patients aged ≥70 years and who have not yet received treatment for CLL.2 To be eligible for enrollment, patients must have intermediate- or high-risk CLL according to the Rai staging system and meet criteria for active treatment, as defined by guidelines established by the 2018 International Workshop on CLL.2

“This trial is important because the majority of patients with CLL are over the age of 70. When studies allow patients of all ages, they naturally skew toward younger patients, so trials that target this older patient population are important to determine the standards of care for [people] we see most often in the clinic,” said Jennifer A. Woyach, MD, Researcher, Leukemia, The Ohio State University Comprehensive Cancer Center, Columbus, and Principal Investigator of Alliance A041702.1

Patients who are randomized to a combination of ibrutinib plus obinutuzumab plus venetoclax in the A041702 trial will receive treatment every 28 days for 14 cycles. One question that study investigators will be trying to answer is whether patients who receive the 3-drug regimen can stop ibrutinib after 14 cycles if they have no evidence of CLL. Dr Thirman explained that patients taking ibrutinib, a standard first-line treatment for CLL, “typically need to stay on that drug indefinitely.”1 Concerns regarding continuous treatment with ibrutinib include the potential for more long-term side effects and high costs. Adverse events associated with ibrutinib, such as high blood pressure, can worsen over time. It is hoped that limiting the amount of time that patients need to take ibrutinib may result in remissions with fewer side effects.1

To learn more about the A041702 trial, patients with CLL who have not yet been treated can talk with their doctors or go to https://clinicaltrials.gov/ct2/show/NCT03737981.

References

  1. Narozniak R. Investigators pursue less-toxic treatment in frontline CLL. April 28, 2020. www.onclive.com/publications/oncology-live/2020/vol-21-no6/investigators-pursue-lesstoxic-treatment-in-frontline-cll. Accessed May 3, 2020.
  2. Clinicaltrials.gov. Testing the addition of a new anti-cancer drug, venetoclax, to the usual treatment (ibrutinib and obinutuzumab) in untreated, older patients with chronic lymphocytic leukemia. https://clinicaltrials.gov/ct2/show/NCT03737981. Accessed May 3, 2020.

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