ASH 2024 | Dose optimization of inotuzumab ozogamicin in adult patients with R/R ALL
Daniel DeAngelo, MD, PhD, Dana-Farber Cancer Institute, Boston, MA, comments on the findings of the Phase IV dose optimization study (NCT03677596) for inotuzumab ozogamicin in adult patients with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL). This randomized study evaluated the relationship between dose and risk-benefit for the labeled dose and a lower dose of inotuzumab ozogamicin (1.2 versus 1.8 mg/m²/cycle) in this patient population. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.
Transcript (AI-generated)
So, inotuzumab is an antibody drug conjugate against CD22. We studied it in a Phase I approach that led to the randomized Phase III INO-VATE study that led to approval. The FDA has a post-approval project which is dose optimization. So they asked us to do a randomized study after approval to make sure we had the right dose. So this is a randomized study of 1.2 versus 1...
So, inotuzumab is an antibody drug conjugate against CD22. We studied it in a Phase I approach that led to the randomized Phase III INO-VATE study that led to approval. The FDA has a post-approval project which is dose optimization. So they asked us to do a randomized study after approval to make sure we had the right dose. So this is a randomized study of 1.2 versus 1.8. The 1.8 is the FDA-approved dose. And we showed as a single agent, the 1.8 is actually the optimal dose, both for efficacy as well as safety.
This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.
Read more...
Disclosures
Amgen, Autolus, Blueprint, Gilead, Incyte, Jazz, Novartis, Pfizer, Servier, Takeda: Consultancy; Mt Sinai MPN Consortium: Other: Mt Sinai MPN Consortium; Daiichi-Sankyo, Fibrogen: Other: DSMB; AbbVie, Blueprint, GlycoMimetics, Novartis: Research Funding; Dana-Farber Cancer Institute: Current Employment.
