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Tebentafusp

Tebentafusp, sold under the brand name Kimmtrak, is a first-in-class bispecific T cell engager approved for the treatment of HLA-A02:01-positive adults with unresectable or metastatic uveal melanoma, a rare and aggressive form of eye cancer.^[1]^[2] It functions as an engineered T-cell receptor (ImmTAC) molecule that targets the gp100 peptide presented by HLA-A02:01 on tumor cells and redirects CD3-positive T cells to induce tumor cell lysis through cytokine release and immune activation.^[2] Administered intravenously on a weekly schedule starting with escalating doses (20 mcg on day 1, 30 mcg on day 8, and 68 mcg thereafter), tebentafusp represents the first therapy to demonstrate a significant overall survival benefit in this patient population.^[1] Developed by Immunocore, tebentafusp emerged from a series of clinical trials beginning with phase I studies in 2016, which established its safety and preliminary efficacy in metastatic uveal melanoma, followed by phase II and pivotal phase III evaluations.^[2] The landmark phase III trial (IMCgp100-202, NCT03070392), involving 378 HLA-A*02:01-positive patients randomized 2:1 to tebentafusp or investigator's choice of therapy (pembrolizumab, ipilimumab, or dacarbazine), reported a median overall survival of 21.7 months with tebentafusp compared to 16.0 months with control therapies (hazard ratio 0.51; 95% CI, 0.37-0.71; p<0.001).^[1]^[2] Long-term follow-up at three years confirmed sustained benefit, with 27% survival in the tebentafusp arm versus 18% in the control group (hazard ratio 0.68; 95% CI, 0.54-0.87).^[3] Median progression-free survival was modestly improved at 3.3 months versus 2.9 months (hazard ratio 0.73; 95% CI, 0.58-0.94; p=0.0139).^[1] The U.S. Food and Drug Administration granted accelerated approval to tebentafusp-tebn on January 25, 2022, based on these results, marking it as the first systemic therapy specifically approved for advanced uveal melanoma, which historically lacks effective treatments due to its distinct biology from cutaneous melanoma.^[1]^[2] Common adverse reactions include cytokine release syndrome (affecting over 80% of patients, mostly grade 1-2), rash, pyrexia, pruritus, fatigue, nausea, chills, and hypotension, with laboratory abnormalities such as decreased lymphocyte count and increased creatinine observed in more than 50% of cases.^[1] Ongoing research explores combinations with immune checkpoint inhibitors and adjuvant use in earlier-stage disease, alongside biomarkers like circulating tumor DNA for response monitoring.^[2]

Medical uses

Indications

Tebentafusp is indicated for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.^[1]^[4] Uveal melanoma is a rare malignancy originating in the uvea—the pigmented middle layer of the eye encompassing the iris, ciliary body, and choroid—and represents the most common primary intraocular cancer in adults, primarily affecting individuals of Caucasian descent.^[5]^[6] Despite effective local therapies for the primary tumor, approximately 50% of patients develop metastatic disease, which most frequently spreads to the liver and carries a poor prognosis with limited prior systemic treatment options.^[6]^[7] The indication is restricted to patients expressing the HLA-A02:01 allele, as tebentafusp targets the gp100 peptide presented specifically by this human leukocyte antigen class I molecule, which is present in about 50% of uveal melanoma patients of European ancestry.^[8]^[2] It has no approved uses in other cancer types or in HLA-A02:01-negative patients.^[1]^[9]

Dosage and administration

Tebentafusp is administered by intravenous infusion over 15 to 20 minutes.^[10] The recommended dosing schedule involves weekly administration with dose escalation to reduce the risk of cytokine release syndrome: 20 mcg on day 1, 30 mcg on day 8, and 68 mcg on day 15 and every week thereafter, continuing until disease progression or unacceptable toxicity.^[10]^[11] The first three infusions should occur in a healthcare setting equipped for managing severe reactions, with monitoring of vital signs during infusion and for at least 16 hours afterward; subsequent infusions may be given in an outpatient setting with at least 30 minutes of post-infusion observation once the 68 mcg dose is tolerated without grade 2 or higher hypotension.^[10]^[11] Prior to initiating treatment, patients must be confirmed positive for the HLA-A*02:01 genotype via validated testing of a whole blood sample.^[10] To mitigate hypotension risks associated with cytokine release syndrome, intravenous fluids should be administered before each infusion based on the patient's volume status and clinical assessment; for those with preexisting adrenal insufficiency on systemic corticosteroids, dose adjustment of the corticosteroid may be necessary.^[11] Liver function tests should be monitored regularly, particularly given the potential for hepatotoxicity.^[10] Preparation for infusion requires a two-step dilution process using aseptic technique: first, add human albumin to a 100 mL bag of 0.9% sodium chloride injection to achieve a 250 mcg/mL albumin concentration, then withdraw the appropriate volume of tebentafusp from the single-dose vial (0.1 mL for 20 mcg, 0.15 mL for 30 mcg, or 0.34 mL for 68 mcg) and add it to the bag, followed by gentle mixing without shaking.^[10] The infusion bag should be polyolefin or polyvinyl chloride compatible, and unused vial contents must be discarded.^[10] No dose reductions are recommended; instead, withhold or permanently discontinue based on adverse reaction severity, per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. For cytokine release syndrome, moderate cases (fever ≥38°C with responsive hypotension or low-flow oxygen need) may require fluid escalation or corticosteroid premedication (e.g., dexamethasone 4 mg) before the next dose if persistent; severe cases (vasopressor-requiring instability or high-flow oxygen need) warrant withholding until resolution, intravenous corticosteroids (e.g., 2 mg/kg/day methylprednisolone), and resumption at the same dose level with premedication; life-threatening cases lead to permanent discontinuation and intravenous corticosteroids.^[10] For hepatotoxicity, grade 3 or 4 elevations necessitate withholding until return to grade 1 or baseline, with resumption at the same dose (or escalation if applicable) and intravenous corticosteroids if no improvement within 24 hours; permanent discontinuation applies for grade 4 events not resolving.^[10] Similar withholding and resumption guidelines apply to other grade 3 adverse reactions, with permanent discontinuation for grade 4.^[10]

Adverse effects

Tebentafusp, a bispecific T-cell engager, commonly induces cytokine release syndrome (CRS) as the primary infusion-related reaction due to rapid T-cell activation and cytokine release upon initial administration. In the phase 3 IMCgp100-202 trial, CRS occurred in 89% of patients (217/245) receiving tebentafusp, with most events classified as grade 1 or 2 according to ASTCT consensus criteria, and severe (grade 3 or 4) CRS in 0.8%.^[10]^[12] Pooled data from three clinical trials (IMCgp100-01, -102, and -202; n=391) reported an all-grade CRS incidence of 88%, with grade 3-4 events in 2%. Across these studies, 60% of patients experienced multiple CRS episodes (median 2, range 1-12), and one fatal case of pulmonary embolism (0.4%) was associated with CRS complications.^[10] Symptoms of CRS typically include fever (76%), chills (47%), hypotension (38-41%), nausea, hypoxia, vomiting, fatigue, and headache, often resolving within a median of 2 days.^[12]^[13] These reactions predominantly occur within 24 hours of infusion, with 84% starting on the day of administration and highest incidence following the first three doses, reflecting the step-up dosing regimen designed to mitigate severity.^[10]^[12] Management of CRS involves close monitoring and supportive care tailored to severity per ASTCT grading: grade 1 (fever without hypotension or hypoxia) requires symptomatic treatment such as antipyretics; grade 2 (hypotension responsive to fluids or low-flow oxygen) includes intravenous fluids and escalation if needed; grade 3 (vasopressor-requiring hypotension or high-flow oxygen) warrants tocilizumab (8 mg/kg IV, maximum 800 mg) as first-line therapy, with or without corticosteroids like methylprednisolone (2 mg/kg/day); and grade 4 (life-threatening) necessitates permanent discontinuation of tebentafusp.^[13]^[10] Prophylaxis with dexamethasone (4 mg IV) is recommended prior to doses if prior grade 2 CRS occurred, alongside pre-infusion IV fluids (e.g., 1 L over 3-5 hours) to prevent hypotension.^[13]^[10] Hospitalization is required for the first three infusions with at least 16 hours of post-infusion monitoring in a setting equipped for rapid intervention, including ICU access and tocilizumab availability.^[10]^[13] Other infusion-related reactions include hypotension in 41% of patients (grade 3-4 in 6%) and dyspnea in 7-12% (grade 3-4 in 1%), often overlapping with CRS and managed similarly with fluids and supportive measures.^[12] In clinical trials, CRS led to dose withholding in 6% and permanent discontinuation in 1.2% of cases.^[10]

Other adverse effects

Tebentafusp treatment is associated with a range of non-infusion-related adverse effects, primarily dermatologic, gastrointestinal, hepatic, and general symptoms, as observed in the phase 3 IMCgp100-202 trial involving 245 patients with metastatic uveal melanoma.^[10] Dermatologic effects are common and often linked to the drug's mechanism targeting gp100-expressing melanocytes. Rash occurs in 83% of patients (18% grade 3 or 4), pruritus in 69% (5% grade 3 or 4), dry skin in 31%, and skin depigmentation or hypopigmentation in 37%. These effects are typically grade 1 or 2, with onset early in treatment and tendency to decrease over time without systemic intervention.^[10]^[11]^[14] Gastrointestinal adverse effects include nausea in 49% of patients (2% grade 3 or 4), vomiting in 30% (1.2% grade 3 or 4), diarrhea (reported as very common, ≥10%), and abdominal pain in 45% (2.9% grade 3 or 4). These symptoms are generally mild to moderate and manageable with supportive care.^[10]^[11] Hepatic effects manifest as elevated liver enzymes, with ALT increased in 52% (9% grade 3 or 4) and AST increased in 55% (13% grade 3 or 4); hyperbilirubinemia occurs in 14%. Hepatotoxicity is reported in 6% of cases, leading to treatment discontinuation in 1%. Elevations often occur early but resolve to grade 1 or lower within a week in most patients.^[10]^[11]^[10] General symptoms frequently reported include fatigue in 64% (6% grade 3 or 4), pyrexia in 76% (3.7% grade 3 or 4), peripheral edema in 45%, and headache in 26%. These are predominantly low-grade and contribute to the overall tolerability profile.^[10] Laboratory abnormalities encompass anemia (hemoglobin decreased) in 51%, thrombocytopenia (platelet count decreased) in 27%, and lymphopenia (lymphocyte count decreased) in 91%. These changes are monitored routinely, with severe cases rare except for lymphopenia (56% grade 3 or 4).^[10] A pooled safety analysis of 410 patients across three trials, reported in September 2025, confirmed similar profiles with CRS in 88%, rash in 92%, pyrexia in 77%, and fatigue in 48%; most adverse events diminished over time, with a 2% discontinuation rate due to toxicity.^[15] Long-term effects include rare adrenal insufficiency, with no evidence of increased infection risk beyond that associated with cytokine release syndrome in the phase 3 trial. Most adverse effects, including dermatologic and hepatic, resolve with supportive care such as antihistamines, topical corticosteroids, or monitoring.^[10]^[12]

Pharmacology

Mechanism of action

Tebentafusp is a recombinant bispecific fusion protein composed of an affinity-matured T-cell receptor (TCR) domain targeting the gp100_280–288 peptide presented in complex with HLA-A*02:01, fused via a disulfide bond to an anti-CD3 epsilon single-chain variable fragment (scFv).^[2] This engineered structure, known as an immune-mobilizing monoclonal TCR against cancer (ImmTAC), enables high-affinity binding to tumor-associated antigens that are typically presented at low densities on cell surfaces.^[16] The TCR domain specifically recognizes and binds to the gp100-HLA-A*02:01 complex on the surface of antigen-expressing tumor cells, such as those in uveal melanoma, while the anti-CD3 scFv simultaneously engages the CD3 complex on the surface of bystander polyclonal T cells.^[17] This dual binding redirects non-tumor-specific T cells to the tumor site, forming a stable immunological synapse that mimics natural T-cell activation but bypasses the need for MHC-restricted antigen presentation to the T cell itself.^[2] The synapse enhances T-cell polarization and adhesion to the target cell, facilitating precise and potent immune engagement.^[16] Upon synapse formation, tebentafusp activates the recruited T cells, triggering the release of cytotoxic molecules including perforin and granzymes, which induce apoptosis in the bound tumor cell through pore formation in the target membrane and activation of caspase pathways.^[17] Concurrently, the activation stimulates cytokine secretion, such as interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), interleukin-2 (IL-2), and interleukin-6 (IL-6), promoting a broader inflammatory response and potential epitope spreading to amplify antitumor immunity.^[2] This mechanism leverages the high specificity of the engineered TCR, which has a 1-million-fold greater affinity than natural TCRs, allowing effective targeting of low-antigen-density gp100 overexpression in tumor cells while minimizing unintended activation due to limited gp100 expression in normal tissues.^[16] The HLA-A*02:01 restriction ensures allele-specific activity, confining efficacy to compatible patients.^[2]

Pharmacokinetics

Tebentafusp is administered intravenously, resulting in immediate bioavailability with maximum plasma concentrations achieved shortly after the end of infusion. Its pharmacokinetics are approximately dose-proportional across the clinical dosing range of 20 to 68 mcg, with no accumulation observed upon weekly administration.^[18] The steady-state volume of distribution is approximately 7.5 L (CV: 24%), indicating limited distribution beyond the plasma volume and vascular compartment. Preclinical studies show accumulation in highly vascular organs such as the liver, lungs, and kidneys, followed by rapid clearance from these tissues.^[18]^[19] As a recombinant fusion protein, tebentafusp is expected to undergo proteolytic degradation into small peptides and amino acids via catabolic pathways, with no involvement of cytochrome P450 enzymes.^[18] Elimination occurs primarily through renal and hepatic clearance mechanisms, with a geometric mean clearance of 16.4 L/day (CV: 24.5%) and a median terminal half-life of 7.5 hours (range: 6.8-7.5 hours). This half-life supports the weekly dosing regimen without significant accumulation.^[20]^[18] Pharmacokinetic parameters are not significantly influenced by body weight (range: 43-163 kg), age (range: 23-82 years), sex, mild to moderate renal impairment, mild hepatic impairment, or Eastern Cooperative Oncology Group (ECOG) performance status. Additionally, HLA-A*02:01 status does not affect tebentafusp pharmacokinetics.^[20]^[18]

History and development

Preclinical and early clinical development

Tebentafusp, also known as IMCgp100, was developed by Immunocore using their proprietary Immune mobilizing monoclonal TCR Against Cancer (ImmTAC) platform, which engineers soluble T-cell receptors fused to anti-CD3 domains to redirect T cells against tumor antigens. This approach marked the first application of a TCR-based bispecific molecule for solid tumors, specifically targeting the gp100 peptide presented in the context of HLA-A*02:01, a complex overexpressed on melanoma cells including those in uveal melanoma. The platform's design leverages high-affinity TCRs selected via phage display to achieve picomolar binding affinity, enabling precise tumor cell recognition while minimizing off-target effects.^[21]^[22] Preclinical evaluation confirmed tebentafusp's ability to redirect both CD8+ and CD4+ T cells against gp100-HLA-A02:01-positive melanoma cells. In vitro studies using HLA-A02:01+ melanoma cell lines, such as Mel624, demonstrated potent T-cell activation, leading to target cell lysis and release of proinflammatory cytokines including IFNγ, TNFα, IL-2, and IL-6, with efficacy dependent on antigen density (effective at 70 peptide copies per cell). These experiments also showed polyfunctional T-cell responses and enhanced antigen cross-presentation by dendritic cells, promoting epitope spreading. In vivo, humanized xenograft models in immunodeficient mice engrafted with gp100+ melanoma cells exhibited significant tumor regression upon tebentafusp administration with human peripheral blood mononuclear cells, driven by T-cell infiltration, immune synapse formation, and sustained cytokine-mediated antitumor activity.^[23]^[24]^[25] The phase 1 trial (NCT01211262), conducted from 2010 to 2015, assessed safety and dosing in 84 patients with advanced HLA-A*02:01-positive melanoma, including cutaneous and uveal subtypes, via weekly intravenous escalation from 5 ng/kg to 900 ng/kg (equivalent to flat doses up to approximately 68 mcg). The maximum tolerated dose was established at 68 mcg weekly, with dose-limiting toxicities primarily consisting of grade 3/4 cytokine release syndrome and hypotension managed through premedication and escalation protocols. Pharmacokinetic analysis revealed a terminal half-life of 6-8 hours, supporting weekly dosing due to rapid clearance and transient cytokine peaks. In the uveal melanoma subset (n=19), early efficacy signals included partial responses in 16% of patients and a 1-year overall survival rate of 65%, surpassing historical benchmarks and prompting further development in this indication.^[26]^[20]^[27] Building on these findings, the phase 2 trial (NCT02570308), from 2016 to 2019, enrolled 127 HLA-A*02:01-positive patients with previously treated metastatic uveal melanoma using an intra-patient dose escalation (20 mcg on day 1, 30 mcg on day 8, then 68 mcg weekly) to reduce cytokine release syndrome incidence and severity. This strategy effectively managed cytokine release syndrome, which occurred in 86% of patients (mostly grade 1/2), through supportive measures like antipyretics and fluids, with severe cases rare and resolved without discontinuation. Preliminary efficacy data showed a disease control rate of 36% (objective response rate 5% plus stable disease 31%) and a 1-year overall survival rate of 62%, representing a substantial improvement over historical controls (1-year OS ~37%). These results established proof-of-concept for tebentafusp in metastatic uveal melanoma. The FDA granted orphan drug designation in January 2016 and breakthrough therapy designation in February 2021 for this indication, reflecting the early clinical promise.^[28]^[29]^[30]

Late-stage clinical trials and approvals

The pivotal phase 3 IMCgp100-202 trial (NCT03070392), conducted from 2017 to 2021, evaluated tebentafusp in 378 patients with previously untreated metastatic uveal melanoma who were HLA-A*02:01-positive, randomizing them 2:1 to tebentafusp or investigator's choice of pembrolizumab, ipilimumab, or dacarbazine.^[12] The primary endpoint was overall survival, with tebentafusp showing a significant improvement, achieving a hazard ratio of 0.51 (95% CI, 0.37-0.71; p<0.001) and median overall survival of 21.7 months compared to 16.0 months in the control arm.^[12] These results established tebentafusp as the first systemic therapy to demonstrate a survival benefit in this population.^[12] A 3-year follow-up analysis of the IMCgp100-202 trial, reported in 2023, confirmed the durability of this benefit, with 3-year overall survival rates of 27% in the tebentafusp group versus 18% in the control group.^[3] The analysis also substantiated efficacy in key subgroups, including patients with liver metastases, the most common site of uveal melanoma spread.^[3] These trial outcomes supported regulatory approvals, including accelerated approval by the U.S. Food and Drug Administration on January 25, 2022, for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.^[1] The European Medicines Agency followed with full marketing authorization on April 1, 2022.^[31] As of November 2025, no additional major approvals have been issued, though investigational access continues via clinical trials. Ongoing late-stage research includes the phase 2/3 trial NCT05549297, assessing tebentafusp monotherapy and in combination with the PD-1 inhibitor pembrolizumab versus investigator's choice in previously treated HLA-A*02:01-positive patients with unresectable or metastatic uveal melanoma.^[32] Additionally, the phase 3 adjuvant trial NCT06246149 is evaluating tebentafusp versus observation in patients with high-risk primary ocular melanoma to prevent relapse.^[33] Post-approval real-world evidence has corroborated the overall survival advantage observed in the pivotal trial among HLA-eligible patients, with 1-year survival rates around 64% in diverse clinical settings.^[34]

Society and culture

Legal status

Tebentafusp received accelerated approval from the U.S. Food and Drug Administration (FDA) on January 25, 2022, for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.^[1] This approval was granted under priority review, with the drug also receiving breakthrough therapy and orphan drug designations prior to approval.^[1] In the European Union, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on January 27, 2022, leading to marketing authorization by the European Commission on April 1, 2022, through the centralized procedure for HLA-A02:01-positive adult patients with unresectable or metastatic uveal melanoma.^[31] Approvals followed in other regions, including Health Canada on June 7, 2022, and the Australian Therapeutic Goods Administration on May 27, 2022, under similar indications.^[35]^[36] As of 2025, access remains limited in Asia, where lower prevalence of the HLA-A02:01 allele and ongoing regulatory delays have prevented widespread approvals. Use of tebentafusp is restricted to patients confirmed positive for HLA-A*02:01 via genotyping, and it is not approved for non-uveal melanoma cancers or HLA-negative patients.^[37] As of November 2025, the FDA approval remains accelerated, with no conversion to full approval; confirmatory trials are required to verify clinical benefit and support continued availability.^[38]

Brand names and availability

Tebentafusp is marketed under the brand name Kimmtrak, with the nonproprietary name tebentafusp-tebn in the United States.^[1] The drug is manufactured by Immunocore Limited, a UK-based biotechnology company, in facilities compliant with Good Manufacturing Practice standards.^[39]^[37] Kimmtrak is supplied as a sterile solution in single-dose vials containing 100 mcg/0.5 mL (equivalent to 200 mcg/mL concentration) for intravenous infusion.^[37]^[11] In approved regions such as the United States, European Union, and United Kingdom, Kimmtrak is distributed exclusively through specialty pharmacies to ensure proper handling and administration.^[40] Due to its high cost—approximately $18,565 per vial in the US as of 2023—Immunocore offers patient assistance programs like KIMMTRAK CONNECT, which provides financial support including copay assistance for eligible patients at no additional cost.^[41]^[42] Immunocore holds composition-of-matter patents for Kimmtrak covering its specific sequences and T-cell receptor variants, with base expiration around 2030 and extensions through patent term adjustments to approximately 2035 in the US (Q1) and major European markets (Q2), as well as supplementary protection certificates in Australia and Canada extending to 2035 or 2032.^[43] Orphan drug designations further grant market exclusivity until January 2029 in the US and up to 2032 in the EU, potentially extendable by two years for pediatric compliance.^[29] As of 2025, no generic or biosimilar versions of tebentafusp are available due to these protections.^[44]

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### Patent Expiration and Exclusivity Information for KIMMTRAK