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Congenital Disorders

Endocrinology and Metabolic Disease

Skin and Musculoskeletal Diseases

Small molecule drug

Monoclonal antibody

Bispecific T-cell Engager (BiTE)

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

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Most frequently developed targets

Disease Domain	Count

Endocrinology and Metabolic Disease	2
Neoplasms	2
Nervous System Diseases	2
Infectious Diseases	2
Immune System Diseases	2
Hemic and Lymphatic Diseases	2

Top 5 Drug Type	Count

Small molecule drug	1
Monoclonal antibody	1
Bispecific T-cell Engager (BiTE)	1

Top 5 Target	Count

CD19 x CD3	1
RANKL(Tumor necrosis factor ligand superfamily member 11)	1
BACE1(Beta-secretase 1)	1

AbstractObjectiveDescribe the demographic profile of US participants in Amgen clinical trials over a 10-year period and variations across therapeutic areas, indications, and geographies.MethodsCross-sectional retrospective study including participants enrolled (2005–2020) in phase 1–3 trials completed between January 1, 2012 and June 30, 2021.ResultsAmong 31,619 participants enrolled across 258 trials, one-fifth represented racial minority populations (Asian, 3%; Black or African American, 17%; American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, multiracial, each < 1%); fewer than one-fifth (16%) represented an ethnic minority population (Hispanic or Latino). Compared with census data, representation of racial and ethnic groups varied across US states. Across most therapeutic areas (bone, cardiovascular, hematology/oncology, inflammation, metabolic disorders, neuroscience) except nephrology, participants were predominantly White (72–81%). A similar proportion of males and females were enrolled between 2005 and 2016; male representation was disproportionately higher than female between 2016 and 2020. Across most medical indications, the majority of participants were 18–65 years of age.Conclusions and RelevanceWhile the clinical research community is striving to achieve diversity and proportional representation across clinical trials, certain populations remain underrepresented. Our data provide a baseline assessment of the diversity and representation of US participants in Amgen-sponsored clinical trials and add to a growing body of evidence on the importance of diversity in clinical research. These data provide a foundation for strategies aimed at supporting more equitable and representative research, and a baseline from which to assess the impact of future strategies to advance health equity.

01 Sep 2024·Gastric Cancer

Bemarituzumab plus mFOLFOX6 as first-line treatment in East Asian patients with FGFR2b-overexpressing locally advanced or metastatic gastric/gastroesophageal junction cancer: subgroup of FIGHT final analysis

Article

Author: Taylor, Kate ; Kang, Yoon-Koo ; Kim, Jong Gwang ; Yamaguchi, Kensei ; Bai, Li-Yuan ; Li, Yong ; Yan, Zhuchen ; Chan, Catherine ; Qin, Shukui ; Yusuf, Akeem ; Zahlten-Kümeli, Anita ; Li, Jin ; Oh, Sang Cheul ; Kim, In-Ho ; Lee, Keun-Wook

AbstractBackgroundIn the FIGHT study (NCT03694522) bemarituzumab, a humanized monoclonal antibody selective for fibroblast growth factor receptor 2b (FGFR2b), plus mFOLFOX6 showed clinically meaningful efficacy in patients with FGFR2b-positive (2+/3+ membranous staining by immunohistochemistry) locally advanced unresectable/metastatic gastric/gastroesophageal cancer (G/GEJC). A meaningful proportion of patients in FIGHT were enrolled in East Asia, reflecting global epidemiology of G/GEJC.MethodsThis subgroup analysis of the global, phase 2, double-blind FIGHT study included all patients enrolled in East Asian sites. Patients were randomized 1:1 to bemarituzumab-mFOLFOX6 (15 mg/kg and one 7.5 mg/kg dose on cycle 1, day 8) or matching placebo-mFOLFOX6. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate, and safety. Efficacy was evaluated after a minimum follow-up of 24 months.ResultsThe East Asian subgroup comprised 89 patients (57% of overall study population); 45 were randomized to bemarituzumab-mFOLFOX6 and 44 to placebo-mFOLFOX6. Median PFS (95% confidence interval [CI]) was 12.9 months (8.8–17.9) with bemarituzumab-mFOLFOX6 and 8.2 months (5.6–10.3) with placebo-mFOLFOX6 (HR 0.50, 95% CI 0.29–0.87); median OS (95% CI) was 24.7 months (13.8–33.1) vs 12.9 months (9.3–21.4), respectively (HR 0.56, 95% CI 0.32–0.96). Treatment benefit was more pronounced in patients with FGFR2b-positive G/GEJC in ≥ 10% of tumor cells. No new safety signals were reported.ConclusionIn East Asian patients with FGFR2b-positive advanced/metastatic G/GEJC enrolled in the global FIGHT study, bemarituzumab-mFOLFOX6 showed clinically meaningful outcomes over placebo-mFOLFOX6.

05 Aug 2024·Journal of Bone and Mineral Research

Evaluating the comparability of osteoporosis treatments using propensity score and negative control outcome methods in UK and Denmark electronic health record databases

Article

Author: Strauss, Victoria Y ; Pedersen, Alma Becic ; Tan, Eng Hooi ; Rathod-Mistry, Trishna ; Prieto-Alhambra, Daniel ; Giorgianni, Francesco ; Baxter, Richard ; O’Kelly, James ; Ehrenstein, Vera ; Brunetti, Vanessa C

AbstractEvidence on the comparative effectiveness of osteoporosis treatments is heterogeneous. This may be attributed to different populations and clinical practice, but also to differing methodologies ensuring comparability of treatment groups before treatment effect estimation and the amount of residual confounding by indication. This study assessed the comparability of denosumab vs oral bisphosphonate (OBP) groups using propensity score (PS) methods and negative control outcome (NCO) analysis. A total of 280 288 women aged ≥50 yr initiating denosumab or OBP in 2011-2018 were included from the UK Clinical Practice Research Datalink (CPRD) and the Danish National Registries (DNR). Balance of observed covariates was assessed using absolute standardized mean difference (ASMD) before and after PS weighting, matching, and stratification, with ASMD >0.1 indicating imbalance. Residual confounding was assessed using NCOs with ≥100 events. Hazard ratio (HR) and 95%CI between treatment and NCO were estimated using Cox models. Presence of residual confounding was evaluated with 2 approaches (1) >5% of NCOs with 95% CI excluding 1, (2) >5% of NCOs with an upper CI <0.75 or lower CI >1.3. The number of imbalanced covariates before adjustment (CPRD 22/87; DNR 18/83) decreased, with 2%–11% imbalance remaining after weighting, matching, or stratification. Using approach 1, residual confounding was present for all PS methods in both databases (≥8% of NCOs), except for stratification in DNR (3.8%). Using approach 2, residual confounding was present in CPRD with PS matching (5.3%) and stratification (6.4%), but not with weighting (4.3%). Within DNR, no NCOs had HR estimates with upper or lower CI limits beyond the specified bounds indicating residual confounding for any PS method. Achievement of covariate balance and determination of residual bias were dependent upon several factors including the population under study, PS method, prevalence of NCO, and the threshold indicating residual confounding.

100 Deals associated with Amgen Ltd.

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100 Translational Medicine associated with Amgen Ltd.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

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Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Blinatumomab ( CD19 x CD3 )	CD19-positive B-cell Precursor acute lymphoblastic leukemia More	Approved
Denosumab ( RANKL )	Giant Cell Tumor of Bone More	Approved
BACE1 inhibitors(Amgen) ( BACE1 )	Parkinson Disease More	Preclinical