Mazyar Shadman, MD, MPH, on Chronic Lymphocytic Leukemia: Recruiting for the CELESTIAL-TNCLL Study
2024 ASCO Annual Meeting
Mazyar Shadman, MD, MPH, of Fred Hutchinson Cancer Center, discusses an ongoing phase III study of the BCL2 inhibitor sonrotoclax plus zanubrutinib vs venetoclax and obinutuzumab for patients with treatment-naive chronic lymphocytic leukemia. The investigators are recruiting internationally (see NCT06073821; Abstract TPS7087).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
This year at the ASCO meeting, I had the opportunity of presenting a trial in progress. This is CELESTRIAL-CLLTN trial, which is a global head-to-head Phase III trial comparing the investigational combination using zanubrutinib, a second generation BTK inhibitor, in combination with sonrotoclax, which is a novel BCL2 inhibitor, and we are comparing that to a standard arm of venetoclax plus obinutuzumab for treatment of first line CLL patients who require treatment.
As a background, we currently have two options for first line treatment of CLL. We either go with continuous BTK inhibitor therapy until progression or intolerance, or we use a time-limited approach using venetoclax in combination with obinutuzumab. If the study is positive, we'll introduce another time-limited option, which is all oral and chemoimmunotherapy free. Zanubrutinib is already approved for CLL in all lines of therapy, and in clinical trial has been shown to be superior to ibrutinib both from the efficacy and safety standpoint.
Sonrotoclax is a novel BCL2 inhibitor, has shown very promising activity both from the safety and efficacy standpoints. In fact, in a study that was presented at ASH in 2023, we saw an extremely effective combination and also very well-tolerated treatment option for CLL patients.
What this study is trying to do is comparing sonrotoclax and zanubrutinib to venetoclax and obinutuzumab. This is a global study with more than 640 patients planned to be enrolled, and patients will be randomized to receive one of the two options. The primary endpoint is progression-free survival, and we are going for superiority of the investigational arm over the standard of care arm.
This study is currently ongoing, and we encourage our colleagues to contact the participating sites and PIs if they have any patients who requires treatment for first line CLL.
Related Videos
The ASCO Post Staff
Narjust Florez, MD, of the Dana-Farber Cancer Institute, and Suresh S. Ramalingam, MD, of Emory University School of Medicine, Winship Cancer Institute, discuss potentially practice-changing phase III results from the LAURA study. This trial showed that osimertinib after definitive chemoradiation therapy improved progression-free survival for patients with unresectable stage III EGFR-mutated non–small cell lung cancer (NSCLC), suggesting this agent may represent a new standard of care in this setting (LBA4).
The ASCO Post Staff
Lisa A. Carey, MD, of the University of North Carolina, Chapel Hill and UNC Lineberger Comprehensive Cancer Center, and Dejan Juric, MD, of the Massachusetts General Hospital Cancer Center, discuss phase III findings on first-line use of inavolisib or placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer who relapsed within 12 months of completing adjuvant endocrine therapy (Abstract 1003).
The ASCO Post Staff
Yasmin H. Karimi, MD, of the University of Michigan Comprehensive Cancer Center, discusses data reaffirming the efficacy and feasibility of using epcoritamab plus R-DHAX/C (rituximab, dexamethasone, cytarabine, and oxaliplatin or carboplatin) in autologous stem cell transplant–eligible patients with diffuse large B-cell lymphoma. Response rates were reported to be high, and most patients proceeded to transplant (Abstract 7032).
The ASCO Post Staff
Thierry Facon, MD, of the University of Lille and Lille University Hospital, discusses phase III findings showing for the first time that isatuximab, an anti-CD38 monoclonal antibody, when given with the standard of care (bortezomib, lenalidomide, dexamethasone, or VRd) to patients with newly diagnosed multiple myeloma who are transplant-ineligible, may reduce the risk of disease progression or death by 40.4% vs VRd alone (Abstract 7500).
The ASCO Post Staff
Minesh P. Mehta, MD, of Miami Cancer Institute, part of Baptist Health South Florida, discusses results from the METIS (EF-25) trial evaluating the efficacy and safety of tumor treating fields therapy following stereotactic radiosurgery in patients with mutation-negative non–small cell lung cancer (NSCLC) and brain metastases. Tumor treating fields therapy prolongs time to intracranial disease progression and may postpone whole-brain radiation therapy without declines in quality of life and cognition (Abstract 2008).