etevritamab (AMG 596) / Amgen - LARVOL DELTA

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - P1 | N=30 | Terminated | Sponsor: Amgen | Completed ➔ Terminated; Amgen business decision

Combination therapy • Monotherapy • Trial termination • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

AMG 596, a novel anti-EGFRvIII bispecific T cell engager (BiTE®) molecule for the treatment of glioblastoma (GBM): planned interim analysis in recurrent GBM (rGBM) (SNO 2019) - P1; "Eligible patients: adults with EGFRvIII-positive GBM or malignant glioma; ≤2 mg/day dexamethasone, ECOG performance status ≤1; life expectancy ≥3 months; and acceptable renal, hematological, and hepatic function. Enrollment is ongoing and additional data will be presented. NCT03296696."

Late-breaking abstract • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • EGFR

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Amgen; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Monotherapy • Trial completion • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • MRI

Novel anti-EGFRvIII bispecific T cell engager (BiTE) antibody construct in glioblastoma (GBM): Trial in progress of AMG 596 in patients with recurrent or newly diagnosed disease. (ASCO 2019) - P1; "For more information, please contact Amgen Medical Information: medinfo@amgen.com. Clinical trial information: NCT03296696"

Clinical • IO Biomarker

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Amgen; Trial primary completion date: Dec 2021 ➔ Jul 2021

Clinical • Combination therapy • Monotherapy • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • MRI

Preclinical Assessment of AMG 596, a BiTE® (Bispecific T-Cell Engager) Immune Therapy Targeting the Tumor-Specific Antigen EGFRvIII. (PubMed, Mol Cancer Ther) - "Cell membrane presentation of EGFRvIII following microvesicle (MV) transfer allows engagement by AMG 596, resulting in T cell activation and T cell-dependent lysis of GBM cells. Together, these data show a compelling preclinical efficacy and safety profile of AMG 596, supporting its development as a novel immune therapy for treatment of GBM."

IO biomarker • Journal • Preclinical • Glioblastoma • Oncology • Solid Tumor

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 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Amgen; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Mar 2021 ➔ Dec 2021

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Amgen; Recruiting ➔ Active, not recruiting; N=200 ➔ 30; Trial completion date: Sep 2024 ➔ Jun 2021; Trial primary completion date: Feb 2024 ➔ Mar 2021

Clinical • Combination therapy • Enrollment change • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - P1; N=200; Recruiting; Sponsor: Amgen; N=82 ➔ 200; Trial primary completion date: Aug 2024 ➔ Feb 2024

Enrollment change • Trial primary completion date

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - P1; N=82; Recruiting; Sponsor: Amgen; Trial completion date: Jun 2022 ➔ Aug 2024; Trial primary completion date: Jun 2022 ➔ Aug 2024

Clinical • Trial completion date • Trial primary completion date

Partial response in Amgen brain cancer study (SeekingAlpha) - P1, N=82; NCT03296696; Sponsor: Amgen; "Amgen's...experimental bispecific T-cell engager, AMG 596, triggered one partial response in a Phase 1 study of patients with an aggressive form of brain tumor known as glioblastoma....The patient saw 70% tumor shrinkage, while four other patients exhibited stable disease, of a total of 19 patients in the study. The trial is ongoing and will continue to enroll."

Enrollment open • P1 data

Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma (clinicaltrials.gov) - P1; N=82; Recruiting; Sponsor: Amgen; Trial completion date: Apr 2021 ➔ Jun 2022; Trial primary completion date: Apr 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date