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ASH 2025 | TaZa CLL: tafasitamab and zanubrutinib in newly diagnosed CLL
Georgios Pongas, MD, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, discusses the results of the ongoing TaZa CLL study (NCT05718869), an investigator-initiated Phase II trial investigating tafasitamab and zanubrutinib in newly diagnosed patients with chronic lymphocytic leukemia (CLL). Dr Pongas highlights the combination’s ability to achieve high overall response rates (ORR) and progression-free survival (PFS), noting that the treatment is well-tolerated. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So in this meeting, we present the results of our investigator-initiated Phase II study of tafasitamab and zanubrutinib in newly diagnosed patients with CLL. So CLL is the most frequent type of leukemia in the Western countries. And while BTKIs and BCL2 inhibitors, they work very well, it remains incurable. So CD19 is a molecule expressing on the surface of the CLL cells, and tafasitamab is a monoclonal antibody that is already FDA-approved for follicular lymphomas and diffuse large B-cell lymphomas...
So in this meeting, we present the results of our investigator-initiated Phase II study of tafasitamab and zanubrutinib in newly diagnosed patients with CLL. So CLL is the most frequent type of leukemia in the Western countries. And while BTKIs and BCL2 inhibitors, they work very well, it remains incurable. So CD19 is a molecule expressing on the surface of the CLL cells, and tafasitamab is a monoclonal antibody that is already FDA-approved for follicular lymphomas and diffuse large B-cell lymphomas. So tafasitamab is an anti-CD19 monoclonal antibody that can go and target the CLL cells, and it has demonstrated activity in CLL when combined with venetoclax and with idelalisib. So, in this study, we evaluated the combination of tafasitamab with zanubrutinib in newly diagnosed CLL. So, patients start with zanubrutinib at 160 milligrams twice a day, tafasitamab, 12 mg per kg, on cycle one, day one, day four, and then weekly for the first three cycles, followed by every two weeks for cycle four to six, and then once monthly for the remainder of the cycles until cycle 24. So it is a fixed duration treatment with MRD assessment in between. So those patients that achieve undetectable MRD at the end of the 12th cycle were able to discontinue the treatment, where those patients that continue to have minimal residual disease after cycle 24, they can continue zanubrutinib only for a total of five years. So in our study, we demonstrated that this combination can achieve high overall response rates of approximately 90%, with 26% of the patients achieving a complete response. During a median follow-up of approximately 16 months, so 95% of the patients achieved a progression-free survival with equal overall survival. It is a well-tolerated treatment. I would say the most frequent adverse effects that were observed were neutropenia and infusion-related reactions from the tafasitamab. The infusion-related reactions were managed with temporary holding of the tafasitamab, and they were able to restart it except one patient that we had to discontinue because of anaphylaxis. Overall, our data demonstrate that this is a well-tolerated combination that can achieve high overall response rates.
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