ASH 2025 | A Phase I study of venetoclax plus inotuzumab ozogamicin for R/R ALL
Marlise Luskin, MD, MSCE, Dana-Farber Cancer Institute, Boston, MA, discusses a Phase I study (NCT05016947) that combined venetoclax and inotuzumab ozogamicin for relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL). Dr Luskin highlights the potential of this combination to improve the depth and durability of response for patients, thereby bridging them to consolidation therapies with curative potential. Dr Luskin notes that the combination was feasible to deliver with a manageable safety profile and encouraging responses. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
I’m really excited this year at ASH to present our Dana-Farber investigator-initiated study combining venetoclax and inotuzumab for ALL that’s been relapsed after prior therapy. This was an idea that we had to combine two agents to treat relapsed ALL. Inotuzumab was approved a few years ago to treat relapsed CD22-positive B-ALL, and that was a major advance and offers quite high remission rates for patients in need of second-line and later line therapy...
I’m really excited this year at ASH to present our Dana-Farber investigator-initiated study combining venetoclax and inotuzumab for ALL that’s been relapsed after prior therapy. This was an idea that we had to combine two agents to treat relapsed ALL. Inotuzumab was approved a few years ago to treat relapsed CD22-positive B-ALL, and that was a major advance and offers quite high remission rates for patients in need of second-line and later line therapy. However, in too many cases, the depth of that remission or the durability of that remission is not as long as we’d hope with a relatively short median survival. So our goal was to try to harness the efficacy of that drug, but enhance it by combining it with venetoclax, a BCL2 inhibitor, where preclinical data suggests sensitivity of lymphoblasts to that agent, as well as sensitivity of lymphoblasts to the combination of that drug, inotuzumab and dexamethasone. So that was the concept really based on preclinical studies, as well as the idea that these drugs would be able to be combined in a convenient way, that the delivery of venetoclax orally and inotuzumab weekly, as well as the known side effect profile of these drugs would allow safe, convenient administration with the goal of then improving the depth and durability of response for patients receiving that as a therapy to get them back into remission and have the opportunity to bridge to curative potential consolidation therapies.
So that was the concept and we enrolled patients over the last few years. It was really exciting to treat these patients and I’ll be presenting those results at this conference, where we show that, as we hoped, the combination was feasible to deliver with safety that we feel encouraged by and encouraging responses in this single-arm study with frequent achievement of deep remissions and a very high proportion of patients bridging to transplantation. It’s really exciting to share these results improving outcomes for B-ALL and we’re hoping that this study will inspire colleagues and others to develop this combination with inotuzumab and venetoclax and other BCL2, BCLxL inhibitors in both the second line and first line settings.
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