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ASH 2023 | An ongoing Phase I trial evaluating AS-1763, a novel non-covalent BTKi, in B-cell lymphomas

Nitin Jain, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, introduces a Phase I dose-escalation study (NCT05602363) evaluating AS-1763, a novel non-covalent BTK inhibitor (BTKi), in the treatment of relapsed/refractory B-cell lymphomas, including chronic lymphocytic leukemia (CLL). The trial is ongoing, with clinical data expected to be presented next year. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.

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Transcript (edited for clarity)

So patients with CLL, the treatment options have changed remarkably over the course of the last several years. Now, we have different BTK inhibitors that have been approved, including ibrutinib, acalabrutinib zanubrutinib, pirtobrutinib. Now, AS-1763 is a novel non-covalent BTK inhibitor, something similar to pirtobrutinib. So this is a Phase I study which we have initiated at MD Anderson, as well as several other institutions in the United States, with the goal of taking patients with relapsed or refractory CLL, most of whom have received a BTK inhibitor and most of whom would have received a BCL2 inhibitor, to treat with this agent to see clinical activity...

So patients with CLL, the treatment options have changed remarkably over the course of the last several years. Now, we have different BTK inhibitors that have been approved, including ibrutinib, acalabrutinib zanubrutinib, pirtobrutinib. Now, AS-1763 is a novel non-covalent BTK inhibitor, something similar to pirtobrutinib. So this is a Phase I study which we have initiated at MD Anderson, as well as several other institutions in the United States, with the goal of taking patients with relapsed or refractory CLL, most of whom have received a BTK inhibitor and most of whom would have received a BCL2 inhibitor, to treat with this agent to see clinical activity. So, this is a Phase I dose-escalation study. It includes patients with CLL, but it also includes patients with other B-cell lymphomas, including DLBCL and mantle cell lymphoma and other lymphomas. So overall, it’s an ongoing Phase I study. We hope to report clinical data sometime next year for this trial.

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Disclosures

Consultancy: AbbVie, Cellectis, TG Therapeutics, Genentech, Beigene, CareDX, Ipsen, MEI Pharma, Janssen, Precision Biosciences, Pharmacyclics, AstraZeneca, Kite/Gilead, Adaptive Biotechnologies, BMS
Honoraria: AbbVie, Cellectis, TG Therapeutics, Genentech, Beigene, CareDX, Ipsen, MEI Pharma, Janssen, Precision Biosciences, Pharmacyclics, AstraZeneca, Kite/Gilead, Adaptive Biotechnologies, BMS
Other (Travel, Accommodation, Expenses): AbbVie, Cellectis, TG Therapeutics, Genentech, Beigene, CareDX, Ipsen, MEI Pharma, Janssen, Precision Biosciences, Pharmacyclics, AstraZeneca, Kite/Gilead, Adaptive Biotechnologies, BMS
Research Funding: AbbVie, Cellectis, Takeda, Genentech, ADC Therapeutics, Servier, TransThera Sciences, Mingsight, Aprea Therapeutics, Medisix, Incyte, Newave, Fate Therapeutics, Dialectic Therapeutics, Novalgen, Loxo Oncology, Pfizer, Precision Biosciences, Pharmacyclics, AstraZeneca, Kite/Gilead, Adaptive Biotechnologies, BMS