Drugs / Talimogene Laherparepvec
Talimogene Laherparepvec
also known as
T-VEC · OncoVEXGM-CSF · Imlygic · JS-1 34.5-HGMCSF · JS1 34.5-HGMCSF 47- PA- · Oncovex · Oncovex-ae · Talimogen laherparepvec · +1 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed melanomatosis 2 milestones | |||||
| Filed | US (FDA) | — | melanomatosis | — | “a Biologics License Application which has been accepted for review by the U.S. Food and Drug Administration ( FDA )” amgen.com ↗ |
| Filed | EU (EMA) | — | melanomatosis | — | “as has a Marketing Authorization Application in the European Union for talimogene laherparepvec” amgen.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Imlygic | — | 2015-12-16 | europa.eu ↗ |
Trials 49
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial · 1 met primary | ||||||
| Phase 0 | NCT03802604 | Dec 2018 → Apr 2022 | breast cancer | SOLTI Breast Cancer Research Group | Completed | Met primary |
| Phase 115 trials | ||||||
| Phase 1 | NCT07102394 | Feb → Dec 2026 expected | neurofibroma, neurofibromatosis type 1 | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 1 | NCT03554044 | Feb 2020 → Dec 2023 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, invasive breast carcinoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT04163952 | Jan 2020 → Mar 2025 | skin squamous cell carcinoma | Rutgers, The State University of New Jersey | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04185311 | Jul 2019 → May 2023 | breast carcinoma in situ, invasive ductal breast carcinoma, triple-negative breast carcinoma | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03663712 | May 2019 → Oct 2022 | peritoneum cancer | Dan Blazer III, M.D. | Completed | No outcome recorded |
| Phase 1 | NCT03300544 | May 2019 → Mar 2022 | rectum adenocarcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03430687 | Jun 2018 → Dec 2019 | bladder carcinoma in situ | University of California, San Francisco | Withdrawn | No outcome recorded |
| Phase 1 | NCT03458117 | Apr 2018 → Feb 2022 | basal cell carcinoma, cutaneous neuroendocrine carcinoma, primary cutaneous lymphoma, squamous cell carcinoma | University of Zurich | Completed | No outcome recorded |
| Phase 1 | NCT03256344 | Mar 2018 → May 2020 | colorectal cancer, triple-negative breast carcinoma | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT03086642 | Nov 2017 → May 2021 | pancreatic ductal adenocarcinoma | Karie D. Runcie, MD | Completed | No outcome recorded |
| Phase 1 | NCT02756845 | Aug 2017 → Jan 2022 | neoplasm | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT03088176 | Jun 2017 → Nov 2020 | melanoma | West Cancer Center | Unknown | No outcome recorded |
| Phase 1 | NCT03064763 | Mar 2017 → Aug 2020 | melanoma | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02626000 | Apr 2016 → Nov 2017 | head and neck carcinoma | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT00402025 | Nov 2006 → Jan 2008 | malignant pancreatic neoplasm | BioVex Limited | Completed | No outcome recorded |
| Phase 1/27 trials · 2 met primary | ||||||
| Phase 1/2 | NCT04599062 | Sep 2020 → Feb 2023 overdue | soft tissue sarcoma | John Rieth | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03597009 | Mar 2019 → Feb 2020 | lung cancer, pleural neoplasm | UNC Lineberger Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03555032 | Jun 2018 → Aug 2021 | melanoma | Royal Marsden NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1/2 | NCT02779855 | May 2017 → Sep 2020 | invasive ductal breast carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | Met primary |
| Phase 1/2 | NCT02509507 | Feb 2016 → Feb 2022 | hepatocellular carcinoma, skin neoplasm | Amgen | Completed | No outcome recorded |
| Phase 1/2 | NCT02453191 | Jul 2015 → Jan 2019 | soft tissue sarcoma | University of Iowa | Completed | No outcome recorded |
| Phase 1/2 | NCT01740297 | Feb 2013 → Aug 2016 | melanoma | Amgen | Completed | Met primary |
| Phase 220 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT06660810 | Mar 2025 → May 2026 overdue | soft tissue sarcoma | John Rieth | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04065152 | Jan 2021 → Feb 2023 | Kaposi's sarcoma | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 2 | NCT04330430 | Sep 2020 → Apr 2023 | metastatic melanoma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT04068181 | Jan 2020 → Aug 2021 | melanoma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02923778 | Dec 2019 → Dec 2026 expected | leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03921073 | Aug 2019 → Sep 2021 | skin angiosarcoma | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03842943 | Jul 2019 → Jun 2026 overdue | cutaneous melanoma | University of Louisville | Recruiting | No outcome recorded |
| Phase 2 | NCT03972046 | Jun 2019 → Feb 2020 | cutaneous melanoma, metastatic melanoma | TriHealth Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT03886311 | May 2019 → Dec 2030 expected | sarcoma | Sarcoma Oncology Research Center, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT03714828 | Dec 2018 → Jul 2023 | keratoacanthoma, skin squamous cell carcinoma | University of Arizona | Completed | Met primary |
| Phase 2 | NCT02965716 | Jun 2018 → Jun 2023 overdue | cutaneous melanoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02978625 | Sep 2017 → Sep 2027 expected | ALK-negative anaplastic large cell lymphoma, ALK-positive anaplastic large cell lymphoma, Sezary syndrome, apocrine adenocarcinoma +18 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03069378 | Mar 2017 → Jul 2025 overdue | epithelioid sarcoma, skin angiosarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | Met primary |
| Phase 2 | NCT02658812 | Aug 2016 → Dec 2021 | inflammatory breast carcinoma, malignant neoplasm of chest wall | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT02819843 | Jun 2016 → Feb 2024 | cutaneous neuroendocrine carcinoma, melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02366195 | Apr 2015 → Jun 2017 | melanoma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02211131 | Feb 2015 → Apr 2019 | — | Amgen | Completed | Missed primary |
| Phase 2 | NCT02014441 | Apr 2014 → Jan 2016 | melanoma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT02574260 | Aug 2008 → Jan 2010 | melanoma | BioVex Limited | Completed | No outcome recorded |
| Phase 2 | NCT00289016 | Dec 2005 → Dec 2008 | melanoma | BioVex Limited | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT02263508 | Dec 2014 → Mar 2021 | melanoma | Amgen | Terminated | Missed primary |
| Phase 3 | NCT01161498 | Feb → Oct 2011 | head and neck cancer, squamous cell carcinoma | BioVex Limited | Terminated | No outcome recorded |
| Phase 3 | NCT01368276 | Oct 2010 → Sep 2014 | melanoma | BioVex Limited | Completed | No outcome recorded |
| Phase 3 | NCT00769704 | Apr 2009 → Feb 2013 | melanoma | BioVex Limited | Completed | Met primary |
| Phase not stated2 trials | ||||||
| — | NCT02147951 | — | melanoma | Amgen | No longer available | No outcome recorded |
| — | NCT02297529 | — | melanoma | Amgen | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02288897 Comparator | Apr 2015 → Apr 2019 | cutaneous melanoma | Provectus Biopharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2017-10-05 | Amgen | Results First Randomized Study To Evaluate IMLYGIC® (Talimogene Laherparepvec), An Oncolytic Viral Therapy, In Combination With A Checkpoint Inhibitor Published In The Journal Of Clinical Oncology amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the Journal of Clinical Oncology has published positive results from the IMLYGIC ® (talimogene laherparepvec) Phase 2 '264 study. |
| 2017-06-03 | Amgen | Results Amgen Presents New Phase 2 Data On IMLYGIC® (Talimogene Laherparepvec) Investigational Combination At ASCO 2017 amgen.com ↗
The analysis showed that 38.8 percent of patients treated with IMLYGIC plus YERVOY achieved an objective response versus 18 percent of patients treated with YERVOY alone (odds ratio=2.9, 95 percent CI: 1.5, 5.5; p =0.002). |
| 2016-06-05 | Merck Sharp & Dohme LLC | Results New Data for KEYTRUDA® (pembrolizumab) in Combination with Talimogene Laherparepvec, Dabrafenib Plus Trametinib, or Low-Dose Ipilimumab in Advanced Melanoma Presented at 2016 ASCO Annual Meeting merck.com ↗
today announced findings from three separate studies evaluating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with other treatment regimens including talimogene laherparepvec, dabrafenib plus trametinib, or low-dose ipilimumab in patients with advanced melanoma. |
| 2015-12-18 | Amgen | Regulatory European Commission Approves Amgen's IMLYGIC™ (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the European Commission has approved the use of IMLYGIC ™ (talimogene laherparepvec) for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral disease. |
| 2015-11-21 | Merck Sharp & Dohme LLC | Results Merck Announces Initial Results for KEYTRUDA® (pembrolizumab) with Novel Immunotherapy Combinations from Three Investigational Studies Presented at the Society for Melanoma Research International Congress merck.com ↗
The findings, which were featured in separate oral presentations today at the Society for Melanoma Research 2015 International Congress (SMR) in San Francisco, showed robust anti-tumor activity with KEYTRUDA in all three combinations studied. |
| 2015-10-27 | Amgen | Regulatory FDA Approves IMLYGIC™ (Talimogene Laherparepvec) As First Oncolytic Viral Therapy In The US amgen.com ↗
Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved the Biologics License Application for IMLYGIC ™ (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. |
| 2015-10-23 | Amgen | Regulatory Amgen Receives CHMP Positive Opinion For IMLYGIC™ (Talimogene Laherparepvec) amgen.com ↗ |
| 2015-09-14 | Amgen | Results Amgen Highlights Key Clinical Data To Be Presented At European Cancer Congress 2015 amgen.com ↗
Durable complete responses (CR) in patients (pts) with stage IIIB-IV melanoma treated with talimogene laherparepvec (T-VEC) in OPTiM |
| 2015-05-26 | Amgen | Results Pivotal Study Results Published in Journal of Clinical Oncology Showed Talimogene Laherparepvec Improved Durable Response Rates in Patients With Metastatic Melanoma amgen.com ↗
Results showed that the primary endpoint of DRR was met, however the secondary endpoint of overall survival (OS) was not met, although there was a strong trend in favor of talimogene laherparepvec. |
| 2015-04-29 | Amgen | Results Amgen To Discuss Details Of The Biologics License Application For Talimogene Laherparepvec For Patients With Metastatic Melanoma amgen.com ↗
At the meeting, Amgen will present the results of the pivotal Phase 3 OPTiM study, which showed that talimogene laherparepvec monotherapy is the first oncolytic immunotherapy to demonstrate therapeutic benefit in a Phase 3 pivotal trial for patients with metastatic melanoma. |
All press releases naming this drug 16 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | talimogene laherparepvec | “This is a phase 3b, multicenter, open-label, single-arm, expanded access study of talimogene laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c...” NCT02297529 ↗50“Treatment with talimogene laherparepvec (T-VEC), a modified herpes simplex virus type-1 (HSV-1), is approved for patients with unresectable stage IIIB-IVM1a melanoma” PMID 35927710 ↗ Aug 2022 “This is single arm Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).” NCT03714828 ↗ “A Phase II Study of Talimogene Laherparepvec (T-VEC) in the Treatment of Locally Advanced Cutaneous Angiosarcoma” NCT03921073 ↗ “Drug: TALIMOGENE LAHERPAREPVEC (TVEC)” NCT02819843 ↗ |
| Known as | Imlygic | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07102394 ↗ |
| Known as | JS-1 34.5-HGMCSF | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108727 ↗ |
| Known as | JS1 34.5-HGMCSF 47- PA- | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108727 ↗ |
| Known as | Oncovex | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108727 ↗ |
| Known as | Oncovex-ae | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108727 ↗ |
| Known as | OncoVEXGM-CSF | “Talimogene laherparepvec (previously known as OncoVEXGM-CSF) is an intratumorally delivered oncolytic immunotherapy comprised of an immune-enhanced herpes simplex virus type-1...” NCT03086642 ↗2“Talimogene laherparepvec (HSV-1 \[strain JS1\]/ICP34.5-/ICP47-/hGM-CSF) is an oncolytic immunotherapy, formerly known as OncoVEXGM-CSF, an immune-enhanced, oncolytic herpes...” NCT06660810 ↗ “Past and ongoing clinical trials by oncolytic HSVs (G207, HSV1716, NV1020, HF10, Talimogene laherparepvec (T-VEC, OncoVEXGM-CSF)) are also summarized.” PMID 29896663 ↗ 2018 |
| Known as | T-VEC | “The primary objective of this open-label, Phase I, trial is to evaluate the toxicity profile of intraperitoneal talimogene laherparepvec (TVEC) in patients with peritoneal...” NCT03663712 ↗13“Talimogene laherparepvec (T-VEC), an oncolytic immunotherapy approved for advanced melanoma, in combination with pembrolizumab may yield enhanced antitumor activity over either...” PMID 32669371 ↗ Jul 2020 “Talimogene laherparepvec (T-VEC) is an oncolytic virus hypothesized to enhance triple-negative breast cancer (TNBC) responses to neoadjuvant chemotherapy (NAC).” PMID 36759673 ↗ Feb 2023 “Talimogene laherparepvec (TVEC) is a replication-competent, immune-enhanced, oncolytic herpes simplex virus type 1 engineered for intratumoral injection;” PMID 34330766 ↗ Jul 2021 “Talimogene laherparepvec (T-VEC) administered by intralesional injection into liver tumors, with ultrasound/computed tomography (US/CT) guidance.” NCT02509507 ↗ “This is single arm Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).” NCT03714828 ↗ “A Phase II Study of Talimogene Laherparepvec (T-VEC) in the Treatment of Locally Advanced Cutaneous Angiosarcoma” NCT03921073 ↗ “Talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles, with or without nivolumab” NCT03597009 ↗ “Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection” NCT03972046 ↗ “Drug: TALIMOGENE LAHERPAREPVEC (TVEC)” NCT02819843 ↗ “Talimogene Laherparepvec (T-VEC)” NCT03458117 ↗ |
| Known as | Talimogen laherparepvec | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108727 ↗ |
| Known as | Talmimogene laherparepvec | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108727 ↗ |
| Action | Deplete | “an oncolytic virus called Talimogene laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells while leaving normal cells alone)” NCT02779855 ↗ |
| Modality | Other / unclassified | “Talimogene laherparepvec (TVEC) is a replication-competent, immune-enhanced, oncolytic herpes simplex virus type 1 engineered for intratumoral injection;” PMID 34330766 ↗ Jul 2021 |
| Route | Other | “intratumoral injection” NCT00289016 ↗ |