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ASH 2024 | Primary endpoint evaluation of a Phase II study of AVO in previously untreated high-risk CLL
Jennifer Brown, MD, PhD, Dana-Farber Cancer Institute, Boston, MA, discusses the efficacy of the acalabrutinib, venetoclax, and obinutuzumab (AVO) regimen in a population of previously untreated patients with chronic lymphocytic leukemia (CLL) enriched for high-risk disease. Dr Brown notes that the primary endpoint analysis of a Phase Il trial (NCT03580928) conducted at her institution showed that the AVO regimen was well-tolerated and resulted in high rates of undetectable measurable residual disease (MRD) in both the overall cohort and the high-risk subgroup, suggesting that it is likely an effective therapeutic approach for high-risk patients. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
One of the trials that was a predecessor to the initiation of the AMPLIFY trial was done at my institution, Dana-Farber Cancer Institute, led by Dr Davids, where we tested the three-drug regimen, acalabrutinib, venetoclax, obinutuzumab, initially in an all-comer population of CLL patients in need of first-line therapy, but then in an enriched cohort, testing the highest risk disease with 17p deletion and p53 abberation...
One of the trials that was a predecessor to the initiation of the AMPLIFY trial was done at my institution, Dana-Farber Cancer Institute, led by Dr Davids, where we tested the three-drug regimen, acalabrutinib, venetoclax, obinutuzumab, initially in an all-comer population of CLL patients in need of first-line therapy, but then in an enriched cohort, testing the highest risk disease with 17p deletion and p53 abberation.
At this meeting we reported the primary endpoint analysis of that trial and it also showed that the AVO regimen was quite favorable and well-tolerated in our patients. The rates of undetectable MRD in the overall cohort were approaching 90 percent. In the high-risk patients they were about 70 to 75 percent which is really quite good for that very high-risk population. So when we consider that that population was excluded from AMPLIFY, the data from our AVO trial is cooperative with the AMPLIFY data in suggesting that the regimen can potentially also be used in the highest risk patients, offering them a better time-limited option than we have had previously for the highest risk disease.
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Disclosures
Pharmacyclics: Consultancy; Grifols Therapeutics: Other: Data Safety Monitoring Board Member; Gilead: Research Funding; Pfizer: Consultancy; Numab Therapeutics: Consultancy; Merck: Consultancy; Loxo/Lilly: Consultancy, Research Funding; iOnctura: Consultancy, Research Funding; Kite: Consultancy; InnoCare Pharma Inc: Consultancy; Genentech/Roche: Consultancy; Grifols Worldwide Operations: Consultancy; MEI Pharma: Research Funding; TG Therapeutics: Research Funding; UpToDate: Patents & Royalties: Author Royalties; Bristol-Myers Squibb: Consultancy; BeiGene: Consultancy, Research Funding; Alloplex Biotherapeutics: Consultancy; Acerta/AstraZeneca: Consultancy; AbbVie: Consultancy.
