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ASH 2024 | Phase Ib study of non-covalent BTKi AS-1763 in previously treated B-cell malignancies
Nitin Jain, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, comments on the potential of a new non-covalent BTK inhibitor (BTKi), AS-1763 (docirbrutnib), in treating relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and other B-cell malignancies. Dr Jain highlights the ongoing Phase I dose escalation study (NCT05602363), which will determine the recommended Phase II dose of the agent. The trial will then be expanded and will eventually enroll patients with mutations conferring pirtobrutinib resistance. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
So patients with CLL these days have many therapy options but when you have a relapsed refractory CLL one of the standard options which is FDA-approved now is a non-covalent BTK inhibitor called pirtobrutinib. AS1763 is a new novel non-covalent BTK inhibitor which at least in the preclinical models have shown that it can work against some of the pirtobrutinib resistance mutations which have been described in patients...
So patients with CLL these days have many therapy options but when you have a relapsed refractory CLL one of the standard options which is FDA-approved now is a non-covalent BTK inhibitor called pirtobrutinib. AS1763 is a new novel non-covalent BTK inhibitor which at least in the preclinical models have shown that it can work against some of the pirtobrutinib resistance mutations which have been described in patients. So this is a Phase I dose escalation study conducted in the United States where we are treating patients not just with CLL but also other B-cell malignancies including mantle cell lymphoma and others. And this is currently an ongoing Phase I study where now we are approaching the recommended Phase II dose and then the plan is to expand the study into CLL and mantle cell lymphoma and eventually we are also going to enroll patients who are pirtobrutinib resistant to see if we see clinical activity among those patients who are pirtobrutinib resistant. So as I said, this is an ongoing study and hopefully at the next year’s ASH we’ll present updated data with a larger cohort of patients.
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Disclosures
Newave: Research Funding; TG Therapeutics: Consultancy, Honoraria, Other: Travel Support; Kite, a Gilead Company: Consultancy, Honoraria, Other: Travel Support, Research Funding; Dialectic Therapeutics: Research Funding; TransThera Sciences: Research Funding; Fate Therapeutics: Research Funding; Servier: Research Funding; Takeda: Research Funding; Pfizer: Research Funding; Aprea Therapeutics: Research Funding; Precision Biosciences: Consultancy, Honoraria, Other: Travel Support, Research Funding; NovalGen: Research Funding; ADC Therapeutics: Research Funding; Ipsen: Consultancy, Honoraria, Other: Travel Support; MEI Pharma: Consultancy, Honoraria, Other: Travel Support; Pharmacyclics: Consultancy, Honoraria, Other: Travel Support, Research Funding; Janssen: Consultancy, Honoraria, Other: Travel Support; Genentech: Consultancy, Honoraria, Other: Travel Support, Research Funding; Cellectis: Consultancy, Honoraria, Other: Travel Support, Research Funding; CareDx: Consultancy, Honoraria, Other: Travel Support; Bristol Myers Squibb: Consultancy, Honoraria, Other: Travel Support, Research Funding; BeiGene: Consultancy, Honoraria, Other: Travel Support; AstraZeneca: Consultancy, Honoraria, Other: Travel Support, Research Funding; Adaptive Biotechnologies: Consultancy, Honoraria, Other: Travel Support, Research Funding; AbbVie: Consultancy, Honoraria, Other: Travel Support, Research Funding; Incyte: Research Funding; Loxo Oncology: Research Funding; Medisix: Research Funding; MingSight: Honoraria, Research Funding.
