acapatamab (AMG 160) / Amgen, BeiGene - LARVOL DELTA

Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) - P1 | N=212 | Terminated | Sponsor: Amgen | Completed ➔ Terminated; Sponsor Decision

Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

#UromigosLive24 T Cell Directed Therapy Panel Part 2: Existing Data for T Cell Engagers in CRPC (YouTube) - "At Uromigos Live 2024, a panel moderated by Brian Rini focused on T cell directed therapy in prostate cancer and featured discussion on topics including cytokine release syndrome and new trials analyzing acapatamab, xaluritamig, and tarlatamab."

Video • Renal Cell Carcinoma

#UromigosLive24 T Cell Directed Therapy Panel Part 1: T Cell Engagers and Cytokine Release Syndrome (YouTube) - "In part one of the session, the panelists discuss T cell engagers, including an introduction and discussion of cytokine release syndrome."

Video

Advances in Immunotherapy for Prostate Cancer: Key Findings From ASCO 2024 — Tanya Dorff, MD, reviews two prostate cancer immunotherapy studies (MedPageToday) - "Tanya Dorff, MD, of City of Hope in Duarte, California, discusses two prostate cancer immunotherapy studies presented at the recent American Society of Clinical Oncology opens in a new tab or window (ASCO) annual meeting. There were two interesting prostate cancer immunotherapy studies at this meeting presented in the rapid oral session. One was the tarlatamab (Imdelltra) studyopens in a new tab or window."

Video

DAVA Think Tank on ​Antibody Drug Conjugates & Bispecifics 2024 (DAVA Oncology) - "March 15, 2024, 11:59 am - 12:06 pm; Enfortumab vedotin + cabozantinib and other EV combinations; March 16, 2024, 10:46 am - 10:53 am; AMG 160, an anti-PSMAxCD3 biospecific for prostate cancer."

Live event

A phase 1 study of acapatamab, a half-life extended, PSMA-targeting bispecific T-cell engager for metastatic castration-resistant prostate cancer. (PubMed, Clin Cancer Res) - "Acapatamab was safe and tolerated and had a manageable CRS profile. Preliminary signs of efficacy with limited durable antitumor activity were observed. Acapatamab demonstrated pharmacokinetic and pharmacodynamic activity."

Journal • Metastases • P1 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=3 | Terminated | Sponsor: Amgen | Phase classification: P1b ➔ P1

Phase classification • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=65 | Terminated | Sponsor: Amgen | Active, not recruiting ➔ Terminated; Amgen made a business decision to discontinue all AMG 160 clinical trials. This decision is not related to safety.

Metastases • Trial termination • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Pembrolizumab in mCRPC - Combination therapies as breakthrough to success? (PubMed, Curr Opin Urol) - "ICI monotherapy seems to be effective in a small biomarker-preselected population, however, there is evidence that especially novel ICI combination approaches can improve patient survival, which could ultimately refocus and revolutionize the treatment of mCRPC."

Combination therapy • IO biomarker • Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) - P1 | N=212 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed | Trial completion date: May 2025 ➔ Jul 2023 | Trial primary completion date: May 2025 ➔ Jul 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=65 | Active, not recruiting | Sponsor: Amgen | N=136 ➔ 65

Enrollment change • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[VIRTUAL] Phase 1 study of AMG 160, a half-life extended BiTE® (bispecific T-cell engager) therapy targeting prostate-specific membrane antigen, in patients with metastatic castration-resistant prostate cancer (SITC 2020) - P1 | "Methods The phase 1 study (NCT03792841) has four parts: AMG 160 monotherapy; AMG 160 in combination with pembrolizumab; AMG 160 monotherapy with etanercept prophylaxis; and AMG 160 monotherapy administered in outpatient centers with 24-hour monitoring. Included in the study are men with histologically/cytologically confirmed mCRPC who are refractory to novel androgen receptor signaling inhibitors: abiraterone, enzalutamide, darolutamide, and/or apalutamide and have failed, refused, or are unsuitable for taxanes; and who have ongoing castration with evidence of progressive disease...The study opened in February 2019 and is currently recruiting patients. Results N/A Conclusions N/A"

Clinical • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FDG PET

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=136 | Active, not recruiting | Sponsor: Amgen | Trial primary completion date: Jan 2023 ➔ Nov 2023

Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[VIRTUAL] AMG 160, a prostate-specific membrane antigen (PSMA)-targeted BiTE® immuno-oncology therapy, is active in models of advanced prostate cancer that are resistant to radioligand therapy (SITC 2020) - P1 | "These data provide a rationale for evaluating AMG 160 in patients with mCRPC who have progressed on 177Lu-PSMA-617. AMG 160 is currently being evaluated in a phase 1 study in patients with mCRPC (NCT03792841)."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[VIRTUAL] AMG 160, a prostate-specific membrane antigen (PSMA)-targeted BiTE® immuno-oncology therapy, is active in models of advanced prostate cancer that are resistant to radioligand therapy (SITC 2020) - P1 | "These data provide a rationale for evaluating AMG 160 in patients with mCRPC who have progressed on 177Lu-PSMA-617. AMG 160 is currently being evaluated in a phase 1 study in patients with mCRPC (NCT03792841)."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Combination of AMG 160, a PSMA x CD3 half-life extended bispecific T-cell engager (HLE BiTE) immune therapy, with an anti-PD-1 antibody in prostate cancer (PCa). (ASCO-GU 2020) - P1; "Activation of autologous T cells within the tumor slices was assayed by flow cytometry, and secretion of cytokines into culture supernatants was measured by Meso Scale Discovery (MSD). Together these data suggest that antitumor efficacy of the AMG 160 HLE BiTE immune therapy can be increased by co-treatment with anti-PD-1. These data provide a rationale for evaluating this combination in future clinical studies. Research Funding: Amgen Inc."

IO Biomarker • PD-L1

Phase I study of AMG 160, a half-life extended bispecific T-cell engager (HLE BiTE) immune therapy targeting prostate-specific membrane antigen (PSMA), in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2020) - P1; "Key exclusion criteria: active autoimmune disease or diseases requiring immunosuppressive therapy (low-dose prednisone permitted); CNS metastases, leptomeningeal disease, or spinal cord compression; prior PSMA-targeted therapy (177Lu-PSMA-617 may be allowed). Clinical trial information: NCT03792841. Research Funding: Amgen Inc."

Clinical • P1 data • FDG PET • MRI

Combination of AMG 160, a PSMA x CD3 half-life extended bispecific T-cell engager (HLE BiTE) immune therapy, with an anti-PD-1 antibody in prostate cancer (PCa). (ASCO-GU 2020) - P1; "Activation of autologous T cells within the tumor slices was assayed by flow cytometry, and secretion of cytokines into culture supernatants was measured by Meso Scale Discovery (MSD). Together these data suggest that antitumor efficacy of the AMG 160 HLE BiTE immune therapy can be increased by co-treatment with anti-PD-1. These data provide a rationale for evaluating this combination in future clinical studies. Research Funding: Amgen Inc."

IO Biomarker • PD-L1

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=136 | Active, not recruiting | Sponsor: Amgen | Trial completion date: Jul 2025 ➔ Nov 2023

Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1b | N=3 | Terminated | Sponsor: Amgen | N=50 ➔ 3 | Trial completion date: Jun 2026 ➔ Jan 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2026 ➔ Dec 2021; Amgen business decision to discontinue AMG 160 20180273.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=136 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1b | N=50 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) - P1 | N=288 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=159 | Recruiting | Sponsor: Amgen | Active, not recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1/2 | N=159 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor