emirodatamab (AMG 427) / Amgen, BeiGene - LARVOL DELTA

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=64 | Terminated | Sponsor: Amgen | N=200 ➔ 64 | Trial completion date: May 2025 ➔ Feb 2023 | Recruiting ➔ Terminated | Trial primary completion date: May 2025 ➔ Feb 2023; Premature discontinuation of study, a strategic decision.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Amgen | Trial completion date: May 2027 ➔ May 2025 | Trial primary completion date: May 2027 ➔ May 2025

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Amgen | Trial completion date: Dec 2025 ➔ May 2027 | Trial primary completion date: Dec 2025 ➔ May 2027

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Amgen | Active, not recruiting ➔ Recruiting | N=130 ➔ 200

Enrollment change • Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=130 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=130; Active, not recruiting; Sponsor: Amgen; Trial completion date: Mar 2023 ➔ Aug 2025; Trial primary completion date: Jan 2023 ➔ Aug 2025

Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Another one BiTEs the dust as Amgen pauses enrollment for phase 1 bispecific trial (FierceBiotech) - "Amgen has stopped enrolling acute myeloid leukemia patients in a phase 1 clinical trial of its half-life extended FLT3 BiTE therapy AMG 427. News of the stoppage comes months after Amgen hit pause on a clutch of other BiTE clinical trials....Amgen last week updated the ClinicalTrials.gov listing for the therapy to “active, not recruiting” without providing an explanation for the decision to stop enrolling new patients."

Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=130; Active, not recruiting; Sponsor: Amgen; Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Amgen Reports First Quarter 2021 Financial Results (PRNewswire) - "The following programs continue to enroll patients in dose escalation studies: (i) BiTE® molecules AMG 330 and AMG 427, targeting CD33 and fms-like tyrosine kinase 3 (FLT3), respectively, for acute myeloid leukemia; (ii) AMG 176, a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1) for hematologic malignancies; (iii) HLE BiTE molecules AMG 199 and AMG 910, targeting mucin 17 (MUC17) and claudin 18.2 (CLDN18.2), respectively, for gastric and gastroesophageal junction cancer; (iv) AMG 509, a bivalent T-cell engager XmAb® 2+1 antibody targeting six transmembrane epithelial antigen of the prostate 1 (STEAP1) for prostate cancer. AMG 256, a bifunctional interleukin-21 agonist for PD-1 positive solid tumors."

Enrollment status • Acute Myelogenous Leukemia • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer • Solid Tumor

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=105; Recruiting; Sponsor: Amgen; Trial completion date: May 2022 ➔ Dec 2022; Trial primary completion date: May 2022 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=105; Recruiting; Sponsor: Amgen; N=70 ➔ 105

Clinical • Enrollment change • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Amgen; Trial completion date: Dec 2021 ➔ May 2022; Trial primary completion date: Dec 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Amgen; Trial completion date: Jan 2021 ➔ Dec 2021; Trial primary completion date: Jan 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date

"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)