AGS62P1 / Astellas - LARVOL DELTA

Safety, tolerability, and pharmacokinetics of ASP1235 in relapsed or refractory acute myeloid leukemia: A phase 1 study. (PubMed, Leuk Res) - P1 | "Six patients achieved composite complete remission (complete remission [CR] + CR with incomplete hematologic recovery + CR with incomplete platelet recovery), 2 of whom proceeded to hematopoietic cell transplantation with long-term leukemia-free survival. This trial was registered at www.clinicaltrials.gov as #NCT02864290."

Journal • P1 data • PK/PD data • Acute Myelogenous Leukemia • Dry Eye Disease • Hematological Disorders • Hematological Malignancies • Keratitis • Leukemia • Ocular Inflammation • Oncology • Ophthalmology • Transplantation • FLT3

Anti-tumor effect of antibody drug conjugate ASP1235 targeting Fms-like tyrosine kinase 3 with venetoclax plus azacitidine in an acute myeloid leukemia xenograft mouse model. (PubMed, Oncotarget) - "Similarly, the combination of ASP1235, venetoclax and azacitidine showed a superior anti-tumor effect in a THP-1 xenograft model without obvious body weight loss. These findings provide supportive evidence that the triple combination of ASP1235, venetoclax and azacitidine would improve the clinical outcome of ASP1235 monotherapy and venetoclax plus azacitidine regimen in AML patients."

Journal • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2 • FLT3

A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1; N=43; Terminated; Sponsor: Astellas Pharma Global Development, Inc.; Phase classification: P=N/A ➔ P1

Clinical • Monotherapy • Phase classification • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P=N/A; N=43; Terminated; Sponsor: Astellas Pharma Global Development, Inc.; Phase classification: P1 ➔ P=N/A; Trial completion date: Jan 2024 ➔ Sep 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: Jan 2022 ➔ Sep 2020; Study was terminated due to lack of efficacy.

Clinical • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1; N=37; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Active, not recruiting; N=60 ➔ 37

Clinical • Enrollment change • Enrollment closed • Monotherapy • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Monotherapy • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1; N=60; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Monotherapy

Metabolism of an Oxime-Linked Antibody Drug Conjugate, AGS62P1, and Characterization of Its Identified Metabolite. (PubMed, Mol Pharm) - "We demonstrated that the metabolite of AGS62P1 is tolerated in rats above 1.5 mg/kg and above 0.334 mg/kg in cynomolgus monkeys when given as a single dose. Furthermore, we established in vitro that pAF-AGL-0185-30 does not significantly inhibit hERG or cytochrome P450 family enzymes (CYPs)."

Journal

"Then why not call out AMG-553, AMG-427 (already in the clinic), ASP1235 (already in the clinic). You're just clout chasing, I get it." (@biologymiology)