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ASH 2025 | TAG-AZA-VEN triplet therapy in patients with BPDCN: results of a Phase II trial
Andrew Lane, MD, PhD, Dana Farber Cancer Institute, Boston, MA, presents the results of a Phase II trial (NCT03113643) investigating the efficacy and tolerability of a triplet therapy consisting of tagraxofusp, azacitidine, and venetoclax (TAG-AZA-VEN) in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Dr Lane highlights that the regimen elicited high response rates: 88% of newly diagnosed patients and 64% of relapsed/refractory (R/R) patients achieved a composite complete response (CRc), and the majority of patients proceeded to allogeneic stem cell transplant (alloSCT) after therapy. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
We’re presenting results of a phase 2 study of a triplet regimen of tagraxofusp, azacitidine, and venetoclax, or TAG-AZA-VEN, in patients with BPDCN. We have preclinical data showing that patients who become resistant to single-agent tagraxofusp, that resistance can be reversed with azacitidine. We also learned that BPDCN cells are particularly sensitive to venetoclax...
We’re presenting results of a phase 2 study of a triplet regimen of tagraxofusp, azacitidine, and venetoclax, or TAG-AZA-VEN, in patients with BPDCN. We have preclinical data showing that patients who become resistant to single-agent tagraxofusp, that resistance can be reversed with azacitidine. We also learned that BPDCN cells are particularly sensitive to venetoclax. And so we moved from the single agent tagraxofusp, which is approved for BPDCN as a five-day dosing regimen, to a triplet regimen with three-day dosing of tagraxofusp with standard AML-based dosing of azacitidine and venetoclax.
What we found is that the regimen was safe. We didn’t have any new safety findings compared to our experience with this triplet regimen in AML patients, which we had previously worked on, or to the tagraxofusp alone, or to venetoclax, azacitidine alone, no new safety findings.
What was very encouraging about the study is the response rates and how patients did after they received the triplet. So in this study, there were two cohorts of patients, patients who were newly diagnosed and patients who had relapsed BPDCN. Both patients had high response rates. Particularly in the frontline treated patients, we had response rates of over 90% with over 80% complete response rates. And in the relapsed patients, we had response rates of over 60%. A second thing that was very encouraging is that a lot of the patients were able to go to an allogeneic stem cell transplant immediately after the therapy, which is always our goal in patients with BPDCN. And that was the majority of patients actually in both arms, the frontline and the relapsed patients.
So overall, we think that this triplet regimen offers a new option for patients with BPDCN because it’s three days dosing of tagraxofusp instead of five, which reduces the amount of monitoring that’s necessary. We think it may have the same safety or even potentially less risk of capillary leak syndrome, which is a risk of single agent tagraxofusp, probably because of the three days instead of the five days. And many patients with BPDCN have another heme malignancy, like MDS or CMML, and it’s attractive to add the venetoclax to the tagraxofusp because it can also cover that component of their disease.
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