Results from Phase II Proof of Concept Studies of Crenolanib in Patients with Mutant AML at the 50th Annual Meeting of the American Society of Clinical Oncology
Online PR News – 04-June-2014 – Arog Pharmaceuticals, LLC announced today that the results from an ongoing Phase II study of monotherapy with oral crenolanib, an investigational selective Type-1 FLT3 inhibitor, in patients with relapsed or refractory FLT3-D835 mutant acute myeloid leukemia (AML) were presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO).
FLT3-D835 mutations in AML is associated with poor prognosis and these patients are more frequent in patients who have progressed after initial therapy. FLT3-D835 patients (n=22) were recruited at two different academic centers, The University of Texas Southwestern Medical Center (NCT01522469) and MD Anderson Cancer Center (NCT01657682), and the combined results from each center were presented in a poster and oral poster highlights session.
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Key preliminary findings are:
Despite having a median of 3 prior therapies, 27% of FLT3-D835 patients achieved a CR/CRi, ( complete remission/ complete remission with incomplete hematologic recovery).
Approximately 18% of FLT3-D835 positive patients were able to proceed to transplant following treatment with crenolanib.
The most commonly observed side effects on both studies were gastrointestinal toxicity (nausea and vomiting) and transaminase elevations. These were primarily grade 1/2 and generally mitigated with dose modifications. No patient experienced an adverse event that resulted in treatment discontinuation.
About FLT3-D835 mutant AML
FLT3-D835 is an activating mutation in the tyrosine kinase domain of FLT3. Approximately 5-7% of newly diagnosed AML patients present with the mutation. Greater than half of FLT3 mutation positive patients who progress following FLT3 inhibitor therapy, specifically sorafenib and quizartinib, develop a FLT3-D835 mutation.
Crenolanib is a highly selective, type I FLT3 tyrosine kinase inhibitor. The compound is currently being developed in AML as well as other FLT3 and PDGFR driven malignancies.
Confirmatory trials evaluating crenolanib as a single agent and in combination with chemotherapy earlier in the course of FLT3 mutant AML are planned.
About AROG Pharmaceuticals
AROG is a privately held, oncology-focused biopharmaceutical company based in Dallas, TX. AROGs mission is to develop novel cancer therapeutics in niche populations with significant unmet medical need. AROG licensed crenolanib from Pfizer in April 2010. To learn more about AROG, visit www.arogpharma.com.
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