emerfetamab (AMG 673) / Amgen - LARVOL DELTA

Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=46; Terminated; Sponsor: Amgen; N=95 ➔ 46; Trial completion date: Mar 2022 ➔ Dec 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: Mar 2022 ➔ Dec 2020; Priortization of other programs

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

CD33 BiTE® Construct Mediated Immunological Synapse Formation and Downstream Signaling in T Cells Is Dependent on Expression of Costimulatory Molecules on Target Cells (ASH 2021) - "Currently, two CD33xCD3 BiTE ® antibody constructs (AMG 330 & AMG 673) are being investigated in phase I dose escalation trials in patients with relapsed/refractory Acute Myeloid Leukemia (AML) with early evidence of acceptable safety and anti-leukemic activity (Ravandi et al., ASH 2020; Subklewe et al., EHA 2020). They support the notion that T cell co-signaling receptors like CD86 and PD-L1 modulate T-cell response in an early event manner. Prospective analyses in clinical trials are needed to validate the relevance of checkpoint molecule expression on target cells as a potential predictive biomarker for response."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Leukemia • Oncology • CD33 • CD86 • MAPK4 • PD-L1 • PTPRC • ZAP70

Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=95; Active, not recruiting; Sponsor: Amgen; Trial completion date: Dec 2021 ➔ Mar 2022; Trial primary completion date: Dec 2021 ➔ Mar 2022

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

Preliminary Results from a Phase 1 First-in-Human Study of AMG 673, a Novel Half-Life Extended (HLE) Anti-CD33/CD3 BiTE® (Bispecific T-Cell Engager) in Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) (ASH 2019) - P1; "Preliminary data of AMG 673 dosed up to 72 µg provide early evidence of the molecule’s acceptable safety profile, drug tolerability, and anti-leukemic activity. An association was observed between PK/PD relationships that were consistent with the biological activity of AMG 673. These preliminary results support further dose escalation of the AMG 673 HLE BiTE® molecule in patients with R/R AML."

Clinical • P1 data • IL2RA

[VIRTUAL] UPDATED RESULTS FROM A PHASE 1 FIRST-IN-HUMAN DOSE ESCALATION STUDY OF AMG 673, A NOVEL ANTI-CD33/CD3 BITE® (BISPECIFIC T-CELL ENGAGER) IN PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (EHA 2020) - P1 | "Preliminary assessment shows an acceptable safety profile with evidence of anti-leukemic activity. These results support schedule optimization and further dose escalation of AMG 673 in patients with R/R AML."

Clinical • P1 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Neutropenia • Oncology • Thrombocytopenia

[VIRTUAL] Updated results from phase 1 dose escalation study of AMG 673, a bispecific T-cell engager molecule, in R/R AML patients (JSMO 2021) - No abstract available

Clinical • P1 data • Acute Myelogenous Leukemia • Oncology

Amgen Reports Fourth Quarter And Full Year 2020 Financial Results (Amgen Press Release) - "...the Company expects to enter AMG 757 into expansion cohorts over the next several months...Clinical development of AMG 673, a half-life extended BiTE molecule targeting CD33, is paused while we gather further information on the CD33 program through progression of AMG 330. Clinical development of AMG 596, a BiTE molecule targeting EGFR variant III for glioblastoma, has been stopped as we prioritize our portfolio. Phase 1 development of the oral MCL-1 inhibitor AMG 397 was paused with focus shifting to the intravenous MCL-1 inhibitor AMG 176, currently in Phase 1 for the treatment of hematologic malignancies."

Pipeline update • Trial status • Glioblastoma • Hematological Malignancies • Lung Cancer • Oncology • Small Cell Lung Cancer

Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=95; Active, not recruiting; Sponsor: Amgen; Recruiting ➔ Active, not recruiting

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

Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=95; Recruiting; Sponsor: Amgen; N=50 ➔ 95; Trial completion date: Oct 2022 ➔ Oct 2021; Trial primary completion date: Oct 2022 ➔ Oct 2021

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

DARTS, Bites and ADCs for the Treatment of AML and for Conditioning for Allogeneic Stem Cell Transplantation (SOHO 2019) - "These include JNJ-63709178; (target: CD123; trial suspended), XmAb14045; (target: CD123), Flotetuzumab/DART; (target: CD123) as well as others focused on CD33 (AMG330, AMG673, AMV564, GEM333) and CLL-1 (MCLA-117). Additional correlative studies will be presented for this and other AML bispecifics currently being tested by our and other groups in the clinic. Finally, we will present data on the use of ADCs for the treatment of AML in vitro and for conditioning for stem cell transplantation within and across MHC barriers using mouse preclinical transplant models."

IO Biomarker

Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Amgen; Trial completion date: Mar 2020 ➔ Oct 2022; Trial primary completion date: Mar 2020 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date