Kimmtrak (tebentafusp-tebn)
/ Immunocore, Medison
- LARVOL DELTA
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September 26, 2026
Survival of Patients With MBD4-Mutated Metastatic Uveal Melanoma Treated With Immune Checkpoint Inhibitors.
(PubMed, Transl Vis Sci Technol)
- "Twelve patients received ICIs (nine pembrolizumab, two ipilimumab + nivolumab, one pembrolizumab + lenvatinib). We observed that, in patients with MBD4-mutated mUM, ICIs achieved a 50% response rate and prolonged survival, demonstrating strong and sustained clinical activity in this distinct molecular subgroup and exceeding outcomes reported with ICIs or tebentafusp. Our findings support further evaluation of MBD4 mutation as a predictive biomarker and suggest that ICIs should be considered as a preferred first-line option in MBD4-mutated mUM."
Checkpoint inhibition • IO biomarker • Journal • Retrospective data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • LXN • MBD4
September 26, 2026
Immune effector cell-associated neurotoxicity syndrome (ICANS) during tebentafusp in metastatic uveal melanoma.
(PubMed, J Dtsch Dermatol Ges)
- No abstract available
Journal • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma
July 17, 2026
Systemic-to-Tumor Immune Transition Is Associated with Clinical Benefit in Tebentafusp-Treated Uveal Melanoma: An Integrative Analysis
(ESMO 2026)
- No abstract available
Clinical • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma
July 17, 2026
A Phase-Based Clinical Management Model for Tebentafusp in Advanced Uveal Melanoma: From Early Toxicity to Treatment De-escalation
(ESMO 2026)
- No abstract available
Clinical • Metastases • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma
July 17, 2026
Tebentafusp discontinuation after sustained disease control in metastatic uveal melanoma (mUM) : a single-center ambispective observational study
(ESMO 2026)
- No abstract available
Clinical • Metastases • Observational data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma
July 17, 2026
Adjuvant tebentafusp (IMCgp100) versus observation in HLA-A*02:01 positive patients following definitive treatment of high-risk uveal melanoma: an EORTC randomized phase III study
(ESMO 2026)
- No abstract available
Clinical • P3 data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • HLA-A
July 17, 2026
Outcomes of Combined Percutaneous Hepatic Perfusion with Ipilimumab plus Nivolumab versus Tebentafusp in Liver-Metastatic Uveal Melanoma
(ESMO 2026)
- No abstract available
Metastases • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma
July 17, 2026
Cytoreductive surgery following tebentafusp (tebe) in metastatic uveal melanoma (mUM): a proof-of-concept case series with translational analysis
(ESMO 2026)
- No abstract available
Clinical • Metastases • Surgery • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma
July 24, 2025
PLUME: A single-arm phase II trial of pembrolizumab (pembro) plus lenvatinib (lenva) in patients (pts) with metastatic uveal melanoma (mUM)
(ESMO 2025)
- P2 | "Clinical trial identification NCT05282901. Table: LBA58 Cohort 1 Tebentafusp-naive HLA A*02-01neg n=22 assessable pts Cohort 2 Tebentafusp-pretreated HLA A*02-01pos n=29 assessable pts Predefined statistical threshold for success ≤16 ≤17 Observed progressions at 27 weeks 15 11 % PFS at 27 weeks [IC95%] 31.8% [13.9 - 54.9] 60.7% [40.6 - 78.5] Conclusions Pembro+lenva met the predefined 27-week PFS success criteria in both Tebe-naïve and Tebe-pretreated cohorts, with particularly encouraging activity in Tebe-pretreated patients. Biomarker and real-world comparisons are ongoing."
Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Eye Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor • Uveal Melanoma
July 16, 2024
Sitravatinib plus tislelizumab for metastatic uveal melanoma with liver metastasis: The open-label, multicenter, phase II GEM-2101 trial
(ESMO 2024)
- P2 | "This study aims to assess the efficacy of the combination of sitravatinib (sitra), a pan-TKI inhibitor (targeting RET, the TAM family (TYRO3, AXL and MER-TK), VEGFR2, and KIT), and tislelizumab (tisle), an anti-PD1 antibody designed to minimize the binding to Fcγ receptors, in patients with MUM and LM. This was a single-arm, phase II trial testing sitra and tisle (sitra+tisle) for systemic treatment-naïve patients or after failure to 1st line tebentafusp if HLA-A02:01. Sitra+tisle showed promising activity with a manageable toxicity profile in patients with MUM and LM. The PFS observed is the longest PFS ever reported for systemic treatment in MUM. An update on translational research to understand synergy between both drugs using correlative liver biopsies is underway."
Clinical • Metastases • P2 data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • AXL • HLA-A • KDR
September 24, 2026
ImmTACs overcome cytotoxic T cell suppression.
(PubMed, Immunother Adv)
- "A first-in-class ImmTAC, Tebentafusp, is approved for the treatment of metastatic uveal melanoma...These data establish that ImmTACs are powerful inducers of CTL cytotoxicity and do so with a comparable efficacy and mechanism as direct engagement of a TCR by peptide-MHC. ImmTACs retain this capability under suppressive conditions comparable to those in the tumor microenvironment."
Journal • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • IFNG
August 06, 2026
Photo- and Heat-Induced Drug Eruption Associated with Combined Trametinib and Tebentafusp Therapy in Metastatic Uveal Melanoma: A Case Report
(EADV 2026)
- No abstract available
Case report • Clinical • Metastases • Eye Cancer • Melanoma • Solid Tumor • Uveal Melanoma
July 24, 2025
Efficacy and safety of IMA203, a PRAME-directed T-cell receptor (TCR) T-cell therapy, in patients with previously treated advanced or metastatic uveal melanoma from a phase I trial
(ESMO 2025)
- P1/2 | "UM with prior tebentafusp, measurable disease (RECIST 1.1) and ECOG PS 0-1. Tolerability was favorable. Further study in a larger UM cohort is warranted and planned."
Clinical • IO biomarker • Metastases • P1 data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • HLA-A • PRAME
September 02, 2026
A review on toxicities of T-cell engager-based therapies in solid tumors.
(PubMed, Ther Adv Med Oncol)
- "To date, two agents have received regulatory approval in this setting: Tebentafusp for metastatic uveal melanoma and Tarlatamab for small-cell lung cancer (SCLC). Cutaneous, immune-related, and hematologic AEs are generally infrequent and rarely severe. Continued optimization of antigen selection, molecular engineering, and pharmacokinetic parameters will be critical to improving the safety profile of TCEs gathering data from clinical trials and real-world experience."
Journal • Review • Eye Cancer • Hematological Disorders • Hematological Malignancies • Lung Cancer • Melanoma • Oncology • Small Cell Lung Cancer • Solid Tumor • Uveal Melanoma • DLL3
July 25, 2022
Results from phase I dose escalation of IMC-F106C, the first PRAME × CD3 ImmTAC bispecific protein in solid tumors
(ESMO 2022)
- P1/2 | "ImmTAC bispecifics redirect polyclonal T cells to target intra/extracellular cancer proteins, as validated by tebentafusp (tebe; gp100×CD3 ImmTAC) with an overall survival benefit in metastatic uveal melanoma (mUM). Conclusions IMC-F106C, the first PRAME×CD3 ImmTAC, is well tolerated and demonstrated durable RECIST partial responses and ctDNA response in PRAME+ pts across multiple tumor types. Dose escalation and multiple expansions are ongoing."
IO biomarker • P1 data • Cutaneous Melanoma • Eye Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Uveal Melanoma • CTLA4 • HLA-A • PRAME
April 25, 2024
Phase 1 safety and efficacy of IMC-F106C, a PRAME × CD3 ImmTAC bispecific, in post-checkpoint cutaneous melanoma (CM).
(ASCO 2024)
- P1/2, P3 | "Stable disease (SD) with any tumor reduction confirmed with ≥ 1 subsequent scan was analyzed based on association with overall survival (OS) for tebentafusp...Pembrolizumab (pembro) dosed at IV 400 mg Q6W... IMC-F106C was well tolerated with promising clinical activity in ICI-pretreated, mCM patients without clinical options. Clinical activity, measured by any confirmed tumor reduction and ctDNA molecular response, is enriched in PRAME+ patients at ~40% and associated with longer PFS and OS. IMC-F106C can be combined with anti-PD1."
Clinical • IO biomarker • P1 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • HLA-A • PRAME
September 23, 2021
Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma.
(PubMed, N Engl J Med)
- P2 | "Treatment with tebentafusp resulted in longer overall survival than the control therapy among previously untreated patients with metastatic uveal melanoma. (Funded by Immunocore; ClinicalTrials.gov number, NCT03070392; EudraCT number, 2015-003153-18.)."
Clinical • IO biomarker • Journal • Cutaneous Melanoma • Dermatology • Eye Cancer • Melanoma • Oncology • Pruritus • Solid Tumor • Uveal Melanoma • HLA-A • TMB
April 28, 2022
Updated overall survival (OS) data from the phase 1b study of tebentafusp (tebe) as monotherapy or combination therapy with durvalumab (durva) and/or tremelimumab (treme) in metastatic cutaneous melanoma (mCM).
(ASCO 2022)
- P1b/2 | "97 of 112 pts were documented as relapsed or refractory to prior anti-PD1 (80% also received ipilimumab). Promising OS is seen in mCM similar to mUM, with both tumor types overexpressing gp100. In mCM relapsed or refractory to prior anti-PD1, tebe with anti–PD-L1 continues to demonstrate promising OS (1-yr, approx. 75%) compared to recent benchmarks (1-yr, approx."
Clinical • Combination therapy • Monotherapy • P1 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor
September 08, 2026
Key barriers in utilizing advanced T-cell engager strategies on solid tumors.
(PubMed, Expert Rev Anticancer Ther)
- "TCEs have demonstrated clinical efficacy in hematologic malignancies and currently show therapeutic potential in solid tumors through the approvals of tebentafusp and tarlatamab in uveal melanoma and small cell lung cancer. Moreover, we highlight the next-generation directions such as engineering of antibody format and combination strategies to overcome these challenges and improve the clinical efficacy. Integrating logical target selection, advanced engineering, biomarker-guided patient stratification, and deliberate clinical design allows TCEs to successfully expand the reach of novel immunotherapeutics into solid tumors."
IO biomarker • Journal • Review • Eye Cancer • Hematological Disorders • Hematological Malignancies • Lung Cancer • Melanoma • Oncology • Small Cell Lung Cancer • Solid Tumor • Uveal Melanoma
July 27, 2023
Three-year survival with tebentafusp in previously untreated metastatic uveal melanoma in a phase III trial
(ESMO 2023)
- P2 | "Methods In this randomized, open-label, Ph3 trial, HLA-A*02:01+ first-line mUM pts were randomized 2:1 to receive tebe or IC of pembrolizumab, ipilimumab or dacarbazine, stratified by LDH. Conclusions This is the longest OS follow-up in a randomized trial in mUM. Tebentafusp continues to provide long-term survival benefit in first line HLA-A*02:01+ pts, with estimated 3-yr OS rate of 27%, further solidifying tebentafusp as first line standard of care in this population."
Late-breaking abstract • Metastases • P3 data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • HLA-A
October 25, 2023
Clinical activity of SD-101 with immune checkpoint inhibition (ICI) in metastatic uveal melanoma liver metastasis (MUM-LM) from the PERIO-01 Phase 1 trial
(SITC 2023)
- P1 | "PFS has been limited, even with approved therapies such as tebentafusp (median 3...Methods PERIO-01 is a phase 1 trial of hepatic arterial SD-101 via PEDD in MUM-LM (NCT04935229), with dose-escalation cohorts as monotherapy (Cohort A), with nivolumab (Cohort B), or nivolumab + ipilimumab (Cohort C)...7 months, MDSC re-programming, and evidence of peripheral and intra-tumoral immune activation. Phase 2 of PERIO-01 is planned for expansion of the optimal dose."
Checkpoint inhibition • Clinical • IO biomarker • Late-breaking abstract • Metastases • P1 data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • ARG1 • CD163 • CD4 • CD8 • FASN • IFNG • IL18 • IL2RA • TNFA
October 25, 2023
Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma.
(PubMed, N Engl J Med)
- P2 | "This 3-year analysis supported a continued long-term benefit of tebentafusp for overall survival among adult HLA-A*02:01-positive patients with previously untreated metastatic uveal melanoma. (Funded by Immunocore; IMCgp100-202 ClinicalTrials.gov number, NCT03070392; EudraCT number, 2015-003153-18.)."
Journal • Metastases • Dermatology • Eye Cancer • Hypotension • Melanoma • Oncology • Pruritus • Solid Tumor • Uveal Melanoma • HLA-A
September 07, 2026
Tebentafusp and liver chemosaturation in metastatic uveal melanoma – update and expansion of a case series from Leipzig
(ADO 2026)
- No abstract available
Clinical • Metastases • Eye Cancer • Melanoma • Solid Tumor • Uveal Melanoma
September 07, 2026
Tebentafusp and liver chemosaturation in metastatic uveal melanoma – update and expansion of a case series from Leipzig
(ADO 2026)
- No abstract available
Clinical • Metastases • Eye Cancer • Melanoma • Solid Tumor • Uveal Melanoma
September 07, 2026
Serial systemic markers of progression dynamics under Tebentafusp in metastatic uveal melanoma
(ADO 2026)
- No abstract available
Metastases • Eye Cancer • Melanoma • Solid Tumor • Uveal Melanoma
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