(Isstories Editorial):- Dallas, Texas Nov 5, 2025 (Issuewire.com) – Arog Pharmaceuticals, Inc., a privately held, late-stage biopharmaceutical company advancing precision therapies for acute myeloid leukemia (AML), today announced that results from its randomized, double-blind, placebo-controlled Phase 3 trial evaluating crenolanib in combination with salvage chemotherapy in patients with relapsed or refractory (R/R) FLT3-mutated AML will be presented as an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, to be held December 6-9, 2025, in Orlando, Florida.
Oral Presentation Details, Abstract 7396
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Presenting Author: Thomas Cluzeau, MD, PhD
Co-Authors: Pierre-Yves Dumas, Pau Montesinos, Gaia Ciolli, Céline Berthon, Felicetto Ferrara, Adriano Venditti, José Antonio Pérez-Simón, Maria Calbacho, Richard Noppeney, Monia Lunghi, Chiara Cattaneo, Fabrizio Pane, Francesco Lanza, Juan Miguel Bergua Burgues, Alessandro Isidori, Yngvar Floisand, Vinay Jain, Eunice Wang
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies
Date & Time: December 8, 2025 | 10:30 AM – 12:00 PM ET
Location: Orange County Convention Center (OCCC) – Chapin Theater (320)
Key Findings
In this international, double-blind study, crenolanib, a potent and selective Type I pan-FLT3 inhibitor, was administered with standard salvage chemotherapy in adults with R/R FLT3-mutated AML.
- The trial met its primary endpoint, demonstrating a statistically significant improvement in event-free survival (EFS) (3.4 vs. 0.0 months; HR = 0.64, p = 0.0145) compared with chemotherapy alone.
- The complete remission (CR/CRi) rate was higher in the crenolanib arm (60% vs. 39%).
- In patients harboring co-mutations in FLT3 and NPM1, median overall survival doubled (12.4 vs. 6.3 months; HR = 0.53, p = 0.0314).
- Crenolanib demonstrated a manageable safety profile consistent with prior studies.
These results reinforce crenolanib’s role as a foundational FLT3-targeted therapy and support its continued clinical development in post-transplant and minimal residual disease (MRD)-positive settings, where disease interception, maintenance, and relapse prevention remain key unmet needs.
About Crenolanib
Crenolanib is a next-generation, orally available Type I FLT3 inhibitor with potent and selective activity against both FLT3-ITD and FLT3-TKD mutations. Unlike earlier-generation inhibitors, crenolanib retains activity against resistant FLT3 variants and has demonstrated durable efficacy in combination regimens. Arog is advancing exploring its role as a post-transplant maintenance and relapse-prevention therapy aimed at long-term disease control and improved survival outcomes.
About Arog Pharmaceuticals, Inc.
Arog Pharmaceuticals is a U.S.-based, late-stage biopharmaceutical company committed to developing best-in-class targeted therapies for hematologic malignancies. The company’s lead investigational therapy, crenolanib, has been evaluated in more than 700 patients across completed and ongoing clinical studies in AML and advanced solid tumors. Founded in 2010 after securing global rights to crenolanib from Pfizer, Arog continues to build on its clinical foundation with a focus on precision oncology and post-transplant disease management.
For more information contact
Edward McDonald
Head, Corporate Development
Amit Patel
Manager, Operations
Arog Pharmaceuticals, Inc.
