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 AML.
Introducing
Now you can personalise
your AML Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe AML 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 AML Hub cannot guarantee the accuracy of translated content. The AML 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.
Bookmark this article
Preliminary findings from a phase I pilot study (NCT00398138) have demonstrated that the Wilms Tumor 1 (WT1) peptide vaccine (galinpepimut-S [GPS]) can be safely administered in Acute Myeloid Leukemia (AML) patients in Complete Remission (CR).1 Based on these findings, Peter G. Maslak, from the Memorial Sloan Kettering Cancer Center, New York, NY, and colleagues, conducted a phase II open-label study (NCT01266083), which is examining the safety and efficacy of GPS in AML patients in First CR (CR1). The results of the study were published in Blood Advances.2
In total, 22 WT1 positive AML patients in CR1 (median age = 64 years, [range 25–76 years]) were enrolled and treated in this study. Patients were administered six vaccinations subcutaneously biweekly over a 10-week period with the possibility of receiving six additional monthly doses if the patient remained in CR1. Of the 22 patients enrolled in this study, 14 (64%) completed more than six vaccinations and 10 (46%) received all 12 vaccine doses.
Additionally, Immune Responses (IRs) were also quantified after the 6th and 12th vaccinations using either CD4+ T-cell proliferation, CD8+ T-cell interferon gamma secretion (enzyme-linked immunospot), or the CD8-relevant WT1 peptide major histocompatibility complex tetramer assay.
The results of this study demonstrated that GPS was safe, well-tolerated and stimulated immunologic responses in most patients with AML in CR1.
However, the authors highlighted that the therapeutic efficacy in this study should be interpreted with caution due to several reasons. Firstly, the patient group in this study were heterogeneous, and thus may skew the outcomes observed. Secondly, the group “may represent those with the best response” as they were in CR1. Lastly, patients who did not achieve IRs still had clinical response which might indicate that the assays used to determine IRs were not sensitive enough.
The authors further concluded that the results from this phase II study were superior to previously published outcomes for similar patient groups treated with conventional post-remission therapies. They further added that regarding the clinical efficacy, a larger randomized clinical trial is required with a more homogeneous patient cohort.
Subscribe to get the best content related to AML delivered to your inbox