All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know ALL.
The ALL Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
Introducing
Now you can personalise
your ALL Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe ALL Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the ALL Hub cannot guarantee the accuracy of translated content. The ALL Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The ALL Hub is an independent medical education platform, sponsored by Jazz Pharmaceuticals, Amgen, and Pfizer. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Inotuzumab ozogamicin in combination with dexamethasone as induction for older patients with B-ALL: Results from the INITIAL-1 study
Bookmark this article
|
Despite advancements in treatment strategies for older patients with ALL (>55 years), the current SoC strategies continue to be associated with high rates of early mortality, significant toxicities, and poor prognosis. Results of the phase II INITIAL-1 (NCT03460522) trial, which evaluated the efficacy and safety of InO combined with dexamethasone as a frontline induction therapy for older patients with Ph− B-ALL, were published in the Journal of Clinical Oncology by Stelljes et al.1 |
| Key learnings |
| 100% of evaluable patients (n = 43) experienced a CR or CRi after two cycles of InO combined with dexamethasone. |
| MRD assessment revealed a molecular CR in 71% of patients after a third cycle of treatment. |
| After a median follow-up of 2.7 years, the 1- and 3-year EFS rates were 88% and 55%, respectively, with 1- and 3-year OS rates of 91% and 73%. |
| The most frequent Grade ≥3 AEs during induction therapy included leukocytopenia in 74%, neutropenia in 56%, thrombocytopenia in 49%, and anemia in 37%. |
| Throughout the 3-year follow-up period, the cumulative incidence of relapse was 27%. |
| These data demonstrate the feasibility of InO as a novel induction strategy in Ph− ALL, offering an alternative to traditional induction therapies for older patients who may not be able to tolerate intensive chemotherapy. |
| InO can be administered in the community, reducing the need for hospitalization and therefore preserving quality of life. |
| There is a need for further trials to establish optimal dosing regimens and to evaluate alternative combinations to further improve patient outcomes. |
Abbreviations: AE, adverse event; ALL, acute lymphoblastic leukemia; B-ALL, B-cell ALL; CR, complete response; CRi, complete response with incomplete hematologic recovery; EFS, event-free survival; InO, inotuzumab ozogamicin; MRD, measurable residual disease; OS, overall survival; Ph−, Philadelphia chromosome-negative; SoC, standard of care.
This educational resource is independently supported by Pfizer. All content is developed by SES in collaboration with an expert steering committee; funders are allowed no influence on the content of this resource.
- Stelljes M, Raffel S, Alakel N, et al. Inotuzumab ozogamicin as induction therapy for patients older than 55 years with Philadelphia chromosome-negative B-precursor ALL. J Clin Oncol. 2024;42(3):273-282. DOI: 1200/JCO.23.00546
More about...
Your opinion matters
2 votes - 80 days left ...
Related articles
Newsletter
Subscribe to get the best content related to ALL delivered to your inbox