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.
The ASCO Post Staff
William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses up to 5.5 years of follow-up data from the phase II CAPTIVATE study, showing that in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), fixed duration ibrutinib plus venetoclax continues to provide clinically meaningful progression-free disease in those with high-risk genomic features as well as in the overall population (Abstract 7009).
The ASCO Post Staff
Tomasz Jankowski, MD, PhD, of Poland’s Medical University in Lublin, discusses a phase II study of THIO, a telomere-targeting agent followed by cemiplimab-rwlc for a difficult-to-treat population of patients with advanced non–small cell lung cancer (Abstract 8601).
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
Efrat Dotan, MD, of Fox Chase Cancer Center, discusses results from the phase II EA2186 trial, the first prospective study aiming to define the optimal treatment approach for vulnerable older adults with newly diagnosed metastatic pancreatic cancer (Abstract 4003).
The ASCO Post Staff
Paula Rodríguez-Otero, MD, PhD, of Spain’s Cancer Center Clínica Universidad de Navarra, and Amrita Y. Krishnan, MD, of the City of Hope Cancer Center, discuss two key studies on B-cell maturation antigen (BCMA)-directed therapies: CARTITUDE-4 on ciltacabtagene autoleucel in patients with functional high-risk multiple myeloma; and DREAMM-7 on belantamab mafodotin-blmf plus bortezomib and dexamethasone vs daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory disease.