talimogene laherparepvec

Trade name: Imlygic

BiologicalapprovedOrphan Drug FDA

Approved

Oct 27, 2015

Talimogene laherparepvec (T-VEC), sold under the brand name Imlygic among others, is a biopharmaceutical medication used to treat melanoma that cannot be operated on; it is injected directly into a subset of lesions which generates a systemic immune response against the recipient's cancer. The final four-year analysis from the pivotal phase 3 study upon which T-VEC was approved by the FDA showed a 31.5% response rate with a 16.9% complete response (CR) rate. There was also a substantial and statistically significant survival benefit in patients with earlier metastatic disease and in patients who had not received prior systemic treatment for melanoma. The earlier stage group had a reduction in the risk of death of approximately 50% with one in four patients appearing to have met, or be close to be reaching, the medical definition of cure. Real world use of talimogene laherparepvec have shown response rates of up to 88.5% with CR rates of up to 61.5%. — Wikipedia

Clinical trial activity

51 trials · 39 clinical orgs · 1 marketing orgs

Phase 1
25
Phase 2
30
Phase 3
5
Phase 4
0

Earliest trial started Dec 1, 2005 (NCT00289016)

Timeline

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Mar 14, 2011

    Orphan Drug Designation

  2. Oct 27, 2015

    Amgen — Earliest FDA Approval

  3. Oct 27, 2015

    Amgen — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedOct 27, 2015

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • imlygic
  • imlygic
  • imlygic
  • js1 34.5-hgmcsf 47- pa-
  • js1 34.5-hgmcsf 47- pa-
  • js1 34.5-hgmcsf 47-pa-
  • oncovex
  • talimogene laherparep
  • talimogene laherparepvec
  • talimogene laherparepvec
  • talimogene laherparepvec
  • talimogene laherparepvec
  • talimogene laherparepvec
  • talimogene laherparepvec
  • talimogene laherparepvec

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07102394Phase 1Feb 1, 2026Amgen, Johns Hopkins University
NCT06660810Early Phase 1 (Phase 1)Dec 1, 2024Amgen, University of Iowa
NCT04599062Phase 1/Phase 2 (Phase 2)Sep 10, 2020Amgen, University of Iowa
NCT04330430Phase 2May 31, 2020Amgen, Netherlands Cancer Institute
NCT04427306Phase 2May 21, 2020Amgen, University of California, Davis
NCT04065152Phase 2Jan 1, 2020Assistance Publique - Hôpitaux de Paris
NCT04068181Phase 2Dec 24, 2019Amgen, Merck
NCT04163952Phase 1Dec 10, 2019National Cancer Institute (NCI), Rutgers University
NCT04185311Phase 1Jul 10, 2019National Cancer Institute (NCI), University of California, Los Angeles
NCT03972046Phase 2Jun 24, 2019TriHealth
NCT03886311Phase 2May 15, 2019Sarcoma Oncology Research Center, LLC
NCT03921073Phase 2Apr 15, 2019University of South Florida
NCT03842943Phase 2Mar 1, 2019University of Louisville
NCT03663712Phase 1Jan 1, 2019Duke University, University of Illinois at Chicago
NCT03554044Phase 1Dec 11, 2018Amgen, University of California, San Francisco
NCT03802604Early Phase 1 (Phase 1)Dec 10, 2018Amgen, Roche, SOLTI Breast Cancer Research Group, University of Barcelona
NCT03597009Phase 1/Phase 2 (Phase 2)Dec 1, 2018Amgen, CareFusion, University of North Carolina at Chapel Hill
NCT03747744Phase 1Sep 28, 2018Free University of Brussels
NCT03714828Phase 2Aug 24, 2018Amgen, University of Arizona
NCT03555032Phase 1/Phase 2 (Phase 2)Jun 26, 2018Royal Marsden Hospital NHS Trust
Showing 20 of 51 trials
Page 1 / 3

Organizations

Research & Development (39)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit321342008
BioVexFor profit6632005
National Cancer Institute (NCI)Government6422017
MerckFor profit3032014
University of IowaAcademic/Hospital3322015
Mary Crowley Cancer CenterAcademic/Hospital2022005
RocheFor profit2012018
Royal Marsden Hospital NHS TrustAcademic/Hospital2122011
Rutgers UniversityAcademic/Hospital2122017
University of California, San FranciscoAcademic/Hospital2212018
University of South FloridaAcademic/Hospital2212017
University of Texas at HoustonAcademic/Hospital2122016
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112020
CareFusionFor profit1012018
Columbia UniversityAcademic/Hospital1112017
Cornell UniversityAcademic/Hospital1112016
CovanceFor profit1012008
Duke UniversityAcademic/Hospital1112019
Free University of BrusselsAcademic/Hospital1112018
Johns Hopkins UniversityAcademic/Hospital1112026
39 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
AmgenFor profitNDAOct 27, 2015