Ching-Kun Wang, Chief Executive Officer and Chief Medical Officer at COTA, shared a post by COTA on LinkedIn, adding:
“I am proud to share that our work with the FDA in acute myeloid leukemia has been published in the American Journal of Hematology. We showed that, despite recent therapeutic advances, patients whose disease contain TP53 mutations or 17p deletions continue to experience very poor outcomes, demonstrating the unmet needs in this aggressive disease. A huge shout out to our collaborators at the FDA for your support and guidance and COTA’s research team for your hard work and dedication throughout the project.”
Quoting COTA‘s post:
“New findings published in the American Journal of Hematology point to a continued unmet need for one of the most aggressive forms of acute myeloid leukemia (AML): patients with TP53 mutations or 17p deletions continue to have very poor outcomes, regardless of current frontline treatment choices.
Using real-world data from COTA, this analysis was conducted in collaboration with our research partners at the FDA and looks at how patients have been treated in routine care from 2013–2023. The work builds on earlier research by Flatiron Health, examining a newer, independent patient population in the post-venetoclax era.
What we found:
Survival remains low across treatment approaches. Patients who received stem cell transplant at any point following frontline therapy experienced longer overall survival. After adjustment for important characteristics including patient age and comorbidities among others, we observed a survival benefit in patients receiving hypomethylating agents (HMA) in combination with venetoclax as compared to HMA alone.
Why it matters:
This study confirms that there remains high unmet need in patients with AML who also harbor TP53 mutations and/or 17p deletions. It also shows that investigational therapies are still underutilized, even when standard options offer limited benefit.
What it means for patients:
The findings reinforce the urgent need for more effective therapies and broader access to investigational options, particularly in community care settings where most patients are treated.
We are proud of the COTA + FDA research collaboration and the role real-world data can play in closing evidence gaps where patients need progress most.
Read the full article in the American Journal of Hematology.”
Title: Real-World Outcomes and Treatment Patterns in Patients With Acute Myeloid Leukemia and TP53 Gene Mutation or 17p Deletion
Authors: Rebecca Bystrom, Laura L. Fernandes, Joseph Wynne, Dianne Pulte, Eric Hansen, Andrew J. Belli, Anna Barcellos, Christina M. Zettler, Jonathon Vallejo, Wenjuan Gu, Angelo DeClaro, Catherine C. Lerro, Ching-Kun Wang, Donna R. Rivera, Kelly J. Norsworthy
Read More about Acute Myeloid Leukemia on OncoDaily.