CD19 modulators(B-lymphocyte antigen CD19 modulators), CD3D modulators(CD3 delta subunit of T-cell receptor complex modulators), CD3ε modulators(CD3e molecule modulators)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication-

Inactive Indication

Diffuse large B-cell lymphoma recurrentFollicular LymphomaMantle-Cell Lymphoma

Originator Organization

Amgen, Inc.

Active Organization-

Inactive Organization

Amgen, Inc.

Drug Highest PhaseDiscontinuedPhase 1

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 931729386H

Source: *****

Sequence Code 524306457L

Source: *****

Sequence Code 631408146H

Source: *****

Clinical Trials associated with Surovatamig

NCT03571828 / TerminatedPhase 1

A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With Relapsed / Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma

Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose [RP2D])

Start Date29 Oct 2018

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Surovatamig

100 Translational Medicine associated with Surovatamig

100 Patents (Medical) associated with Surovatamig

Literatures (Medical) associated with Surovatamig

08 Sep 2022·Blood

T-cell exhaustion induced by continuous bispecific molecule exposure is ameliorated by treatment-free intervals

Article

Author: Theurich, Sebastian ; Vick, Binje ; Straub, Tobias ; Bücklein, Veit ; Sponheimer, Monika ; Leutbecher, Alexandra ; Kazerani, Maryam ; von Bergwelt-Baildon, Michael ; Kischel, Roman ; Weigert, Oliver ; Marcinek, Anetta ; Scheurer, Michaela ; Nixdorf, Daniel ; Philipp, Nora ; Wulf, Jan ; Rejeski, Kai ; Nicholls, Alyssa ; Subklewe, Marion ; Brauchle, Bettina ; Lacher, Sonja M. ; Muth, Amelie ; Jeremias, Irmela ; Ohlmeyer, Malte ; Rohrbacher, Lisa ; Hänel, Gerulf

AbstractT-cell–recruiting bispecific molecule therapy has yielded promising results in patients with hematologic malignancies; however, resistance and subsequent relapse remains a major challenge. T-cell exhaustion induced by persistent antigen stimulation or tonic receptor signaling has been reported to compromise outcomes of T-cell–based immunotherapies. The impact of continuous exposure to bispecifics on T-cell function, however, remains poorly understood. In relapsed/refractory B-cell precursor acute lymphoblastic leukemia patients, 28-day continuous infusion with the CD19xCD3 bispecific molecule blinatumomab led to declining T-cell function. In an in vitro model system, mimicking 28-day continuous infusion with the half-life–extended CD19xCD3 bispecific AMG 562, we identified hallmark features of exhaustion arising over time. Continuous AMG 562 exposure induced progressive loss of T-cell function (day 7 vs day 28 mean specific lysis: 88.4% vs 8.6%; n = 6; P = .0003). Treatment-free intervals (TFIs), achieved by AMG 562 withdrawal, were identified as a powerful strategy for counteracting exhaustion. TFIs induced strong functional reinvigoration of T cells (continuous vs TFI-specific lysis on day 14: 34.9% vs 93.4%; n = 6; P < .0001) and transcriptional reprogramming. Furthermore, use of a TFI led to improved T-cell expansion and tumor control in vivo. Our data demonstrate the relevance of T-cell exhaustion in bispecific antibody therapy and highlight that T cells can be functionally and transcriptionally rejuvenated with TFIs. In view of the growing number of bispecific molecules being evaluated in clinical trials, our findings emphasize the need to consider and evaluate TFIs in application schedules to improve clinical outcomes.

100 Deals associated with Surovatamig

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diffuse large B-cell lymphoma recurrent	Phase 1	US	Amgen, Inc.	29 Oct 2018
Diffuse large B-cell lymphoma recurrent	Phase 1	DE	Amgen, Inc.	29 Oct 2018
Diffuse large B-cell lymphoma recurrent	Phase 1	CA	Amgen, Inc.	29 Oct 2018
Diffuse large B-cell lymphoma recurrent	Phase 1	BE	Amgen, Inc.	29 Oct 2018
Follicular Lymphoma	Phase 1	US	Amgen, Inc.	29 Oct 2018
Follicular Lymphoma	Phase 1	BE	Amgen, Inc.	29 Oct 2018
Follicular Lymphoma	Phase 1	CA	Amgen, Inc.	29 Oct 2018
Follicular Lymphoma	Phase 1	DE	Amgen, Inc.	29 Oct 2018
Mantle-Cell Lymphoma	Phase 1	US	Amgen, Inc.	29 Oct 2018
Mantle-Cell Lymphoma	Phase 1	CA	Amgen, Inc.	29 Oct 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03571828 (Phase I study of AMG 562, CTgov)	Phase 1	Mantle-Cell Lymphoma \| Follicular Lymphoma \| Diffuse large B-cell lymphoma recurrent	10	AMG 562 (Cohort 1: AMG 562 0.1 μg)	dictujrygf(dnllcpdrbz) = zvbotzwzkt qcpabpifax (ydlksfpcgo, ticxygqshf - hbplqmqsbr) View more	-	22 Mar 2024
NCT03571828 (Phase I study of AMG 562, CTgov)	Phase 1		10	AMG 562 (Cohort 2: AMG 562 0.3 μg)	dictujrygf(dnllcpdrbz) = ltfjsvtmvy qcpabpifax (ydlksfpcgo, ntkhbndqlb - hhqzjfgcgq) View more	-	22 Mar 2024
NCT03571828 (Phase I study of AMG 562, ICML2021)	Phase 1	Mantle-Cell Lymphoma \| Follicular Lymphoma \| Diffuse large B-cell lymphoma recurrent CD19 \| CD3	9	AMG 562 0.1mg	(omctmchvog) = n = 1, Gr 4 gabdyhdhhs (zztzzhzagz ) View more	Negative	17 Jun 2021

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