arsenic trioxide oral (QTX-2101) / Quetzal Therapeutics - LARVOL DELTA

QUATRO-APL: A PIVOTAL OPEN-LABEL PHASE 3 TRIAL EVALUATING THE EFFICACY AND SAFETY OF QTX-2101 IN COMBINATION WITH ALL-TRANS RETINOIC ACID IN NEWLY DIAGNOSED, LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (EHA 2026) - "Background Intravenous (IV) arsenic trioxide (ATO) combined with all ‑ trans retinoic acid (ATRA) has transformed outcomes in a ll risk acute promyelocytic leukemia, leading to >90% molecular complete remission ( mCR ) rates and favorable l ong ‑ term survival...Aims Th is is a randomized, open ‑ label, multicenter Phase 3 study evaluating the efficacy and safety of oral QTX ‑ 2101 plus ATRA compared with IV ATO plus ATRA in adults with newly diagnosed l ow- ri sk acute promyelocytic leukemia (LR-APL)...Based on prior clinical experience, the lower C max associated with oral QTX ‑ 2101 may support improved tolerability versus IV ATO; effects on QTc and other safety parameters will be assessed in this study. With comparable systemic exposure, QTX ‑ 2101 is intended to m aintain the established efficacy of IV ATO while reducing treatment burden , enabling a fully oral approach for patients with LR ‑ APL with the potential to e stablish a new frontline standard of care."

Clinical • Combination therapy • P3 data • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • PML

Quetzal Therapeutics Announces First Patient Dosed in Phase 3 QUATRO-APL Trial of QTX-2101 for Frontline Acute Promyelocytic Leukemia (GlobeNewswire) - "Quetzal Therapeutics expects continued site activation and patient enrollment across the United States and Europe as the global Phase 3 program advances and plans to provide additional updates on study progress as enrollment continues....QUATRO-APL (QTX-2101-301) is a pivotal, open-label Phase 3 clinical study evaluating the efficacy, safety, and pharmacokinetics of QTX-2101, an oral capsule formulation of arsenic trioxide, in combination with all-trans retinoic acid (ATRA), in adult patients with newly diagnosed, low-risk acute promyelocytic leukemia."

Trial status • Acute Promyelocytic Leukemia

Quetzal Therapeutics…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to QTX-2101, the company’s investigational oral arsenic trioxide capsule, for the treatment of patients with acute promyelocytic leukemia (APL). (GlobeNewswire) - "QTX-2101 is currently being evaluated in a global, multicenter, randomized, controlled Phase III clinical trial comparing the investigational oral capsule to standard-of-care therapy in patients with newly diagnosed APL."

Fast track • Acute Promyelocytic Leukemia

Quetzal Therapeutics Launches Phase III Clinical Trial of Oral QTX-2101 for Acute Promyelocytic Leukemia (APL) (GlobeNewswire) - "This global, multicenter, randomized, controlled study will compare QTX-2101 to standard-of-care therapy in patients with newly diagnosed APL."

New P3 trial • Acute Promyelocytic Leukemia