Drugs / Tebentafusp
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed susceptibility to uveal melanoma 4 milestones | |||||
| Filed | Other | — | susceptibility to uveal melanoma | 2021-11-10 | “Additionally, the Australian Government Department of Health has accepted the Marketing Application for tebentafusp in mUM” immunocore.com ↗ |
| Filed | UK (MHRA) | — | susceptibility to uveal melanoma | 2021-09-08 | “United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted a Market Authorisation Application (MAA) seeking the approval of tebentafusp (IMCgp100)” immunocore.com ↗ “the United Kingdom’s Medicines and Healthcare products Regulatory Agency has accepted a MAA seeking the approval of tebentafusp for the treatment of patients with mUM” immunocore.com ↗ |
| Filed | EU (EMA) | — | susceptibility to uveal melanoma | 2021-08-24 | “The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), accepted Immunocore’s Marketing Authorization Application (MAA).” immunocore.com ↗ “As previously announced, the FDA and European Medicines Agency have accepted the Biologics License Application (BLA) and MAA respectively for tebentafusp.” immunocore.com ↗ |
| Filed | US (FDA) | — | susceptibility to uveal melanoma | 2021-08-24 | “Immunocore’s biologics license application for approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma was recently...” immunocore.com ↗ “As previously announced, the FDA and European Medicines Agency have accepted the Biologics License Application (BLA) and MAA respectively for tebentafusp.” immunocore.com ↗ “The U.S. Food and Drug Administration (FDA) has accepted for review Immunocore’s Biologics License application (BLA) for tebentafusp (IMCgp100).” immunocore.com ↗ “In August, the U.S. Food and Drug Administration (FDA) accepted for review Immunocore’s BLA for tebentafusp.” immunocore.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Kimmtrak | — | 2022-04-01 | europa.eu ↗ |
| Approved | US (FDA) | KIMMTRAK | — | 2022-01-25 | fda.gov ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01209676 | Sep 2010 → Mar 2013 | melanoma | University of Pennsylvania | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT01211262 | Sep 2010 → Feb 2016 | melanoma | Immunocore Ltd | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06626516 | Oct 2025 → Oct 2030 expected | uveal melanoma | Thomas Jefferson University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04262466 | Feb 2020 → Oct 2026 expected | cancer | Immunocore Ltd | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02570308 | Feb 2016 → Mar 2020 | uveal melanoma | Immunocore Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT02535078 | Nov 2015 → Jun 2023 | melanoma | Immunocore Ltd | Withdrawn | No outcome recorded |
| Phase 29 trials · 1 met primary | ||||||
| Phase 2 | NCT07276386 | Dec 2025 → Dec 2030 expected | uveal melanoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06942442 | Oct 2025 → Oct 2030 expected | MHC class I deficiency 2, clear cell sarcoma | Sarcoma Alliance for Research through Collaboration | Recruiting | No outcome recorded |
| Phase 2 | NCT06414590 | Sep 2025 → Aug 2027 expected | uveal melanoma | Thomas Jefferson University | Recruiting | No outcome recorded |
| Phase 2 | NCT06070012 | Aug 2025 → Sep 2028 expected | uveal melanoma | Diwakar Davar | Recruiting | No outcome recorded |
| Phase 2 | NCT07057596 | Jul 2025 → Dec 2027 expected | uveal melanoma | Spanish Melanoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06627244 | Feb 2025 → Feb 2028 expected | uveal melanoma | University of Miami | Recruiting | No outcome recorded |
| Phase 2 | NCT05315258 | Jul 2022 → Dec 2026 expected | cutaneous melanoma, uveal melanoma | University of Oxford | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03070392 | Oct 2017 → Oct 2020 | uveal melanoma | Immunocore Ltd | Completed | Met primary |
| Phase 2 | NCT02889861 | Jan 2017 → Apr 2019 | melanoma | Immunocore Ltd | Terminated | No outcome recorded Stop: Business |
| Phase 32 trials | ||||||
| Phase 3 | NCT06246149 | Nov 2024 → Nov 2032 expected | uveal melanoma | European Organisation for Research and Treatment of Cancer - EORTC | Recruiting | No outcome recorded |
| Phase 3 | NCT05549297 | Dec 2022 → Mar 2028 expected | melanoma | Immunocore Ltd | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04960891 | — | uveal melanoma | Immunocore Ltd | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05785754 Background | Jun 2023 → Dec 2026 expected | — | DynamiCure Biotechnology | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-04-19 | Immunocore Ltd | Results KIMMTRAK doubles the likelihood of being alive at five years for first line HLA-A*02:01+ patients with metastatic uveal melanoma immunocore.com ↗
KIMMTRAK doubled the likelihood of being alive at five years, with an OS for KIMMTRAK of 16% versus 8% in the control arm (hazard ratio [HR] of 0.67 [95% CI: 0.54-0.85]). |
| 2024-12-03 | Immunocore Ltd | Regulatory Immunocore announces reimbursement agreement in England for KIMMTRAK▼ for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma immunocore.com ↗
Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced that KIMMTRAK (tebentafusp) has been recommended for funding through the National Health Service (NHS) in England by the National Institute for Health and Care Excellence (NICE). |
| 2024-09-14 | Immunocore Ltd | Results Immunocore presents Phase 1 data of brenetafusp, an ImmTAC bispecific targeting PRAME, in patients with ovarian cancer immunocore.com ↗
T cell fitness gene expression signature in blood is an important parameter of clinical activity for tebentafusp in uveal melanoma and for brenetafusp across different tumor types |
| 2024-06-01 | Immunocore Ltd | Results Immunocore presents KIMMTRAK clinical data demonstrating that patients with stable disease and confirmed tumor reduction have similar clinical outcomes to patients with partial response immunocore.com ↗
These data showed that treatment benefit for patients with stable disease and any confirmed tumor reduction was similar to patients with partial response. |
| 2024-04-24 | Immunocore Ltd | Results Immunocore announces upcoming presentation and posters at ASCO 2024 immunocore.com ↗
Stable disease with confirmed tumor reduction has a similar clinical outcome as RECIST partial response for tebentafusp in metastatic uveal melanoma |
| 2023-10-21 | Immunocore Ltd | Results Immunocore presents three-year overall survival data from the KIMMTRAK Phase 3 trial immunocore.com ↗
In the Phase 3 trial follow up – the longest of any randomized trial for metastatic uveal melanoma – the three-year OS rate was 27% in the KIMMTRAK arm, versus 18% in the control arm (investigator’s choice, predominantly [82%] single agent pembrolizumab). |
| 2023-06-03 | Immunocore Ltd | Results Immunocore presents additional ctDNA data from the KIMMTRAK Phase 3 trial at ASCO immunocore.com ↗
In this analysis of the Phase 3 data for patients with best response of stable disease treated with KIMMTRAK, ctDNA reduction by week 9 was observed in 94% of patients (34/36) with detectable ctDNA at baseline |
| 2023-04-18 | Immunocore Ltd | Results Immunocore presents new KIMMTRAK data confirming association between early ctDNA reduction and longer overall survival immunocore.com ↗
In the Phase 3 trial, early on-treatment ctDNA reduction was strongly associated with longer overall survival (OS) |
| 2022-11-11 | Immunocore Ltd | Results Immunocore presents new biomarker analysis for KIMMTRAK (tebentafusp-tebn) in metastatic uveal melanoma at the SITC 2022 Annual Meeting immunocore.com ↗
We also demonstrate that gp100 protein remains unchanged even in patients who had disease progression. |
| 2022-06-08 | Immunocore Ltd | Regulatory The UK Medicines and Healthcare products Regulatory Agency (MHRA), Australian Therapeutic Goods Administration (TGA) and Health Canada approve KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma immunocore.com ↗
Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases today announces that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), the Therapeutic Goods Administration (TGA) in Australia and Health Canada have granted marketing authorization for KIMMTRAK® (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). |
| 2022-06-06 | Immunocore Ltd | Results Immunocore presents new data on KIMMTRAK (tebentafusp-tebn) in metastatic cutaneous (mCM) and uveal melanoma (mUM) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting immunocore.com ↗
In mCM patients who progressed on prior anti-PD(L)1, tebentafusp with durvalumab continues to demonstrate promising overall survival (OS) (1-yr ~75%) compared to recent benchmarks (1-yr ~55%). |
| 2022-04-04 | Immunocore Ltd | Regulatory European Commission Approves KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma immunocore.com ↗
Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases today announces that the European Commission (EC) has approved KIMMTRAK® (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). |
| 2022-02-25 | Immunocore Ltd | Regulatory Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma immunocore.com ↗
Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma |
| 2022-01-26 | Immunocore Ltd | Regulatory Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma immunocore.com ↗
Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma |
| 2021-11-09 | Immunocore Ltd | Results Immunocore presents new data on tebentafusp in metastatic cutaneous melanoma (mCM) and uveal melanoma (mUM) at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting immunocore.com ↗
Tebentafusp in combination with checkpoint inhibitors had acceptable safety profile; preliminary evidence of clinical activity in anti-PD(L)1 relapsed/refractory mCM |
| 2021-09-22 | Immunocore Ltd | Results Immunocore announces publication of phase 3 data comparing tebentafusp with investigator’s choice in The New England Journal of Medicine immunocore.com ↗
Results from the randomized, open-label, phase 3 trial of tebentafusp vs. investigator’s choice in previously untreated HLA-A*02:01-positive patients with mUM demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. |
| 2021-09-20 | Immunocore Ltd | Results Immunocore presents data at the European Society for Medical Oncology (ESMO) Congress 2021 demonstrating a reduction in circulating tumor DNA (ctDNA) while on tebentafusp is associated with overall survival in the Phase 2 clinical trial immunocore.com ↗
The findings presented by Alexander N. Shoushtari MD, medical oncologist at Memorial Sloan Kettering Cancer Center, demonstrated that reduction by Week 9 in circulating tumor DNA (ctDNA) while on tebentafusp is strongly associated with overall survival (OS). |
| 2021-09-08 | Immunocore Ltd | Regulatory Immunocore Announces UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) Accepts Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma immunocore.com ↗
Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announces that United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted a Market Authorisation Application (MAA) seeking the approval of tebentafusp (IMCgp100) for the treatment of patients with metastatic uveal melanoma (mUM). |
| 2021-08-24 | Immunocore Ltd | Regulatory Immunocore Announces that U.S. Food and Drug Administration and European Medicines Agency accept Biologics License Application and Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma immunocore.com ↗
The U.S. Food and Drug Administration (FDA) has accepted for review Immunocore’s Biologics License application (BLA) for tebentafusp (IMCgp100). |
| 2021-06-04 | Immunocore Ltd | Results Immunocore presents clinical data further characterizing the overall survival benefit of tebentafusp in metastatic uveal melanoma at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting immunocore.com ↗
In patients with a best response of progressive disease (PD) in the phase 3 trial, the overall survival (OS) was superior for the tebentafusp arm versus the investigator’s choice arm with a hazard ratio (HR) of 0.43 (95%CI 0.27-0.68). |
| 2021-04-28 | Immunocore Ltd | Results Immunocore Announces Upcoming Presentations at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting immunocore.com ↗
Immunocore’s most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. |
| 2021-04-12 | Immunocore Ltd | Results Immunocore presents phase 3 data comparing tebentafusp with investigator’s choice in the clinical trial plenary session at the American Association for Cancer Research 2021 Annual Meeting immunocore.com ↗
Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. |
| 2021-02-19 | Immunocore Ltd | Regulatory Immunocore’s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA immunocore.com ↗
We are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from our Phase 3 clinical trial announced in November 2020. |
All press releases naming this drug 29 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tebentafusp | “IMCgp100 (tebentafusp, Kimmtrak)” NCT03070392 ↗ |
| Known as | IMCgp100 | “This study was a mixed phase Ib/II, multi-center, open-label study of tebentafusp (IMCgp100) as a single agent” NCT02535078 ↗ |
| Known as | IMMTAC IMCGP100 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297990 ↗ |
| Known as | ImmTAC IMCgpgp 100 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297990 ↗ |
| Known as | Kimmtrak | “IMCgp100 (tebentafusp, Kimmtrak)” NCT03070392 ↗ |
| Known as | Tebentafusp-Tebn | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06414590 ↗ |
| Action | Activate | “an anti-CD3 fragment that is meant to bind to and activate the T cells” NCT01209676 ↗ |
| Modality | Protein / enzyme biologic | “a monoclonal T cell receptor anti-CD3scFv fusion protein” NCT01209676 ↗ |
| Route | Other | “single intratumoral dose” NCT01209676 ↗ |
| Target | PMEL | “Melanocyte protein PMEL binding agent” CHEMBL4297990 ↗ |