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
Peter Riedell, MD, of The University of Chicago, discusses phase III results on the use of tucidinostat plus R-CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL) with double expression of MYC and BCL2. The regimen appeared to improve event-free survival and complete response rates vs R-CHOP in the front-line setting. As this is an interim analysis, longer-term follow-up will be needed to better understand its impact, says Dr. Riedell.
Ciara C. O’Sullivan, MD, MBBCh, of Mayo Clinic, discusses three studies of treatment for patients with HER2-positive metastatic breast cancer and their clinical implications: the EMERALD trial of eribulin and taxane; the Patricia Cohort C trial of palbociclib plus trastuzumab and endocrine therapy; and DB07 on trastuzumab deruxtecan with or without palbociclib.
The ASCO Post Staff
Alex Andrea Francoeur, MD, of UC Irvine Health, discusses data showing an association between the increasing incidence of endometrial cancer and obesity, which disproportionately affects younger women and women of color. According to Dr. Francoeur, the findings warrant targeted health services and public health interventions to stabilize and ultimately reverse the rising rates (Abstract 5507).
The ASCO Post Staff
Joseph A. Greer, PhD, of Massachusetts General Hospital and Harvard Medical School, discusses study findings showing the merits of delivering early palliative care via telehealth vs in person to patients with advanced lung cancer. Using telemedicine in this way may potentially improve access to and more broadly disseminate this evidence-based care model (LBA3).
The ASCO Post Staff
Thomas Powles, MD, PhD, of Barts Cancer Institute and the University of London, and Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discuss clinical outcomes of sacituzumab govitecan-hziy after prior exposure to enfortumab vedotin-ejfv in patients with metastatic urothelial carcinoma, as well as the safety and efficacy of fam-trastuzumab deruxtecan-nxki in patients with HER2-expressing bladder tumors (Abstracts 4502 and 4509).