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DRUG:

pavurutamab (AMG 701)

i
Other names: AMG 701, AMG701, AMG-701
Company:
Amgen, BeiGene
Drug class:
CD3 agonist, BCMA inhibitor
Related drugs:
1m
Phase classification • Combination therapy
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pomalidomide • pavurutamab (AMG 701) • dexamethasone injection
over1year
Trial completion • Trial completion date • Combination therapy
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pomalidomide • pavurutamab (AMG 701) • dexamethasone injection
4years
[VIRTUAL] A Phase 1 First in Human (FIH) Study of AMG 701, an Anti-B-Cell Maturation Antigen (BCMA) Half-Life Extended (HLE) BiTE® (bispecific T-cell engager) Molecule, in Relapsed/Refractory (RR) Multiple Myeloma (MM) (ASH 2020)
All grade 3 CRS (n=5, 7%) were assessed as dose-limiting toxicities (DLTs); all were reversible with corticosteroids and tocilizumab, with median duration of 2 days. As of July 2, 2020, 75 patients received AMG 701. Patients had a median age of 63 years, a median time since diagnosis of 5.9 years, and a median (range) of 6 (1-25) prior lines of therapy; 27% of patients had extramedullary disease, 83% prior SCT, and 93% prior anti-CD38 Ab; 68% were triple refractory to a PI, an IMiD, and an anti‑CD38 Ab. Median (Q1, Q3) treatment duration was 6.1 (3.1, 15.3) weeks and median follow-up on treatment was 1.7 (1.0, 3.7) months.
P1 data • IO biomarker
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CD38 (CD38 Molecule)
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Actemra IV (tocilizumab) • pavurutamab (AMG 701)
4years
The immunomodulatory drugs lenalidomide and pomalidomide enhance the potency of AMG 701 in multiple myeloma preclinical models. (PubMed, Blood Adv)
Importantly, the combination of AMG 701 with lenalidomide induced sustained inhibition of MM cell growth in SCID mice reconstituted with human T cells; tumor regrowth was eventually observed in cohorts treated with either agent alone (P < .001). These results strongly support AMG 701 clinical studies as monotherapy in patients with RRMM (NCT03287908) and the combination with IMiDs to improve patient outcomes in MM.
Preclinical • Journal
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IL10 (Interleukin 10)
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lenalidomide • pomalidomide • pavurutamab (AMG 701)
5years
AMG 701 Potently Induces Anti-Multiple Myeloma (MM) Functions of T Cells and IMiDs Further Enhance Its Efficacy to Prevent MM Relapse In Vivo (ASH 2019)
Combination of AMG 701 and len significantly induced superior MM cell regression, compared to either monotherapy, resulting in enhanced tumor regression and prevention of disease relapse. Taken together, these results strongly support AMG 701-based clinical studies, both as monotherapy (NCT03287908) and in combination with IMiDs to enhance elimination of residual diseases and prolong long-term durable responses in MM.
Preclinical • IO biomarker
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
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pavurutamab (AMG 701)