KIMMTRAK (tebentafuspe) is the first and only approved treatment for Brazilian adult patients living with this disease
SÃO PAULO, Brazil – [March 18th, 2025]: Medison Pharma, a global company focused on accelerating access to highly innovative therapies in international markets, and Immunocore Holdings plc (NASDAQ: IMCR), a commercial-stage biotechnology company focused on pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, are pleased to announce that KIMMTRAK® (tebentafuspe) has received marketing authorization from ANVISA, the Brazilian Health regulatory agency, under the rare diseases approval pathway.
Tebentafuspe is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). This is the first therapy approved by ANVISA for metastatic uveal melanoma in Brazil[1],2.
Uveal melanoma is a rare and aggressive eye cancer, with limited treatment options available in advanced stage. Once metastasized, it carries a poor prognosis, and survival rates have remained largely unchanged for decades3. Developed by Immunocore, tebentafuspe is a groundbreaking Immune Mobilizing Monoclonal T cell receptor Against Cancer (ImmTAC) therapy4, designed to engage the body's immune system to specifically target and destroy uveal melanoma cells.
As part of their long-standing global partnership, Medison and Immunocore are collaborating to bring this therapy to Latin America and additional regions outside US, Japan and Western Europe. Brazil has become the first country in the region to approve the treatment, which offers a novel treatment option to patients living with this disease5.
Mark Moyer, Senior Vice President, Regulatory Sciences at Immunocore said, “Following the marketing approval, HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in Brazil now have access to tebentafusp. With approvals in 39 countries, this underscores Immunocore’s steadfast commitment to providing our medicines to patients who can benefit from them around the world.”.
The approval of tebentafuspe in Brazil emphasizes Medison’s commitment to expanding access to innovative oncology treatments in Latin America. Victor Papamoniodis, Chief Commercial Officer of Medison Pharma, stated: “We are proud of our global partnership with Immunocore that allows us to bring this treatment to Brazilian patients, who have not had access to an approved therapy until now. Medison is dedicated to delivering the most advanced therapies for rare and severe diseases to patients worldwide.
Edson Paixao, Head of Brazil, Andean, Central America & Caribbean of Medison Pharma, said: "Medison remains committed to accelerating access to highly innovative therapies for Brazilian patients. The approval of tebentafuspe is an important milestone, and we take pride in making this therapy available to those patients who can benefit from it."
About KIMMTRAK® (tebentafuspe)
Solution for infusion with 100 micrograms/0.5 mL in a package containing 1 vial of 0.5 mL.
INTRAVENOUS USE
ADULT USE
WARNING: Cytokine Release Syndrome (CRS), which can be serious or life-threatening, has occurred in patients receiving KIMMTRAK®. Monitor for at least 16 hours after the first three infusions and then as clinically indicated.
Indications: As monotherapy for the treatment of adult patients with unresectable or metastatic uveal melanoma positive for human leukocyte antigen (HLA) A*02:01. Patients treated with KIMMTRAK® must have an HLA-A*02:01 genotype determined by any validated HLA genotyping assay.
Contraindications: Hypersensitivity to the active substance or to any of the excipients listed.
Warnings and Precautions: Most patients experienced CRS after tebentafuspe infusions. The diagnosis of CRS was most frequently based on pyrexia followed by hypotension and infrequently on hypoxia. Other symptoms frequently observed with CRS included chills, nausea, vomiting, fatigue and headache. In most cases, CRS began on the day of infusion, with a median time to resolution of 2 days. Pyrexia was observed in nearly all cases of CRS and usually occurred within the first 8 hours after infusion. CRS rarely (1.2%) led to discontinuation of treatment. Patients should be monitored for signs and symptoms of CRS for at least 16 hours after the first three infusions in a hospital setting with immediate access to medications and resuscitation equipment to manage CRS. If CRS is observed, immediate supportive care, including antipyretics, intravenous fluids, tocilizumab, or corticosteroids, should be initiated to prevent worsening of the syndrome or potential fatality, and monitoring should continue until resolution. With subsequent doses, patients should be closely monitored after treatment for early identification of signs and symptoms of CRS. Patients with comorbidities, including cardiovascular disorders, may be at increased risk of sequelae associated with CRS. Tebentafuspe treatment has not been studied in patients with clinically significant cardiac disease. Depending on the persistence and severity of CRS, tebentafuspe treatment should be withheld or discontinued. Acute skin reactions with infusion have been reported, including rash, pruritus, erythema, and skin edema. Cardiac events, such as tachycardia and sinus arrhythmia, have been observed in patients receiving treatment. Cases of QT prolongation have been reported following treatment with tebentafuspe. An ECG should be performed on all patients before and after treatment, during the first 3 weeks and thereafter as clinically indicated. This medicine may potentiate the prolongation of the QT interval, which increases the risk of severe ventricular arrhythmias such as "torsades de pointes", which is potentially fatal (sudden death). This medicine may cause hepatotoxicity. Therefore, it requires careful use, under strict medical supervision and accompanied by periodic controls of liver function at the physician's discretion.
Pregnancy and lactation: women of childbearing potential must use effective contraception during treatment and for at least 1 week after the last dose of treatment. The medicine is not recommended during pregnancy and in women of childbearing potential who are not using contraception. The existence of pregnancy in women of childbearing potential should be verified before starting treatment. There is insufficient information on the excretion of tebentafuspe/metabolites in human milk. Any risk to newborns/infants cannot be excluded. Breastfeeding should be discontinued during treatment with tebentafuspe.
Drug, food and alcohol interactions: No formal interaction studies have been performed with tebentafuspe. Initiation of tebentafuspe therapy causes a transient release of cytokines that may suppress CYP450 enzymes. The highest risk of drug-drug interactions occurs within the first 24 hours of the first three doses in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index. These patients should be monitored for toxicity (e.g., warfarin) or drug concentrations (e.g., cyclosporine). The dose of concomitant medications should be adjusted as necessary.
Dosage: Hospitalization is recommended for at least the first three infusions. The recommended dose is 20 micrograms on Day 1, 30 micrograms on Day 8, 68 micrograms on Day 15, and 68 micrograms once weekly thereafter. Treatment should continue as long as the patient derives clinical benefit and in the absence of unacceptable toxicities. To minimize the risk of hypotension associated with CRS, intravenous fluids should be administered prior to initiating the infusion, based on clinical assessment and the patient's volume status. Tebentafuspe should be withheld or discontinued to manage adverse reactions. The recommended infusion period is 15 to 20 minutes.
Adverse Reactions and Laboratory Test Abnormalities: The most common adverse reactions in patients treated with tebentafuspe were CRS (88%), rash (85%), pyrexia (79%), pruritus (72%), fatigue (66%), nausea (56%), chills (55%), abdominal pain (49%), edema (49%), hypo/hyperpigmentation (48%), hypotension (43%), dry skin (35%), headache (32%), and vomiting (34%). Adverse reactions led to permanent discontinuation in 4% of treated patients. The most common adverse reaction resulting in discontinuation of tebentafuspe was CRS. Adverse reactions resulting in at least one dose interruption occurred in 26% of treated patients (weekly dosing) and resulted in a median of one missed dose. Adverse reactions requiring discontinuation of dosing in ≥2% of patients included fatigue (3%; Grade 1-3), pyrexia (2.7%; Grade 1-3), increased alanine aminotransferase (2.4%; Grade 1-4), increased aspartate aminotransferase (2.4%; Grade 1-3), abdominal pain (2.1%; Grade 1-3), and increased lipase (2.1%; Grade 1-3). Adverse reactions requiring dose modification in ≥1% of patients were CRS (1.9%; Grade 1-3) and hypotension (1.1%; Grade 2-4). Very common adverse reactions were: CRS, decreased appetite, hypomagnesemia, hyponatremia, hypocalcemia, hypokalemia, insomnia, headache, dizziness, paresthesia, tachycardia, hypotension, flushing, hypertension, cough, dyspnea, nausea, vomiting, diarrhea, abdominal pain, constipation, dyspepsia, rash, pruritus, dry skin, hypo/hyperpigmentation, erythema, arthralgia, back pain, myalgia, pain in extremities, pyrexia, fatigue, chills, edema, flu-like illness, increased aspartate aminotransferase, increased alanine aminotransferase, increased serum bilirubin, increased lipase, anemia, decreased lymphocyte count, decreased serum phosphates, increased serum creatinine. See other adverse reactions in the product's full leaflet.
Registration: 1.9132.0001/ Medison Pharma Brasil Produtos Farmacêuticos LTDA/CNPJ 48.682.588/0001-37/ Rua Nelson Pontes, 125 Bloco 5 e 6. Jardim Margarida. Vargem Grande Paulista/SP/Indústria Brasileira/ KIMMTRAK®-MB01-22/SAC: 0800-633-4766. SALE UNDER PRESCRIPTION. USE RESTRICTED TO HEALTHCARE ESTABLISHMENTS. If symptoms persist, a physician should be consulted. Scientific documentation and additional information are available from the Customer Service Department and the service department for prescribers and dispensers of medications. Product information approved by Anvisa available at https://consultas.anvisa.gov.br/#/bulario/
About Medison Pharma
Medison, the creator and leader of the global partnership category, is a global commercial platform focused on providing access to highly innovative therapies to patients in international markets.
Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of global partnerships with leading biotech companies seeking to expand their global reach.
To learn more visit www.medisonpharma.com.
About Immunocore
Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune diseases and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including clinical and pre-clinical programs in oncology, infectious diseases, and autoimmune diseases. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK, has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom. To learn more visit www.immunocore.com.
About Medison’s Partnership with Immunocore
Medison has a global partnership with Immunocore to commercialise tebentafuspe across more than 25 countries in five continents for the treatment of unresectable or metastatic uveal melanoma, a rare and aggressive form of melanoma. This partnership is central to Medison’s belief that every patient, wherever they are in the world, deserves a fair chance to receive lifesaving, highly innovative therapies.
Regulatory Approval and Jurisdiction Limitations
The regulatory approval status of tebentafuspe described in this press release refers exclusively to Brazil territory, as granted by the Brazilian Health Regulatory Agency (ANVISA). The approval status, indications, and product labelling may vary across jurisdictions. Nothing in this communication shall be construed as an authorization for use, commercialization, or promotion of the product in any country in which such approval has not been obtained. For country-specific regulatory information, please refer to the relevant national health authority.
Global Distribution
This press release is intended / may be distributed globally through media and press release platforms. The availability, approval, and lawful use of tebentafuspe are subject to country’s specific jurisdiction requirements, which may differ from those described herein. Nothing in this communication shall be construed as an offer, promotion, or solicitation for the use of tebentafuspe in any country where such activities are not permitted under applicable laws and regulations. Readers are encouraged to consult the relevant regulatory authorities in their respective jurisdictions for the most current up-to date information about the product.
All product and company names, and registered trademarks mentioned herein are the property of their respective owners. Their inclusion in this communication shall not be considered an endorsement, affiliation, or authorization of any kind for its use or reproduction in any jurisdiction where such rights have not been granted. Any unauthorized usage, reproduction, or distribution of these trademarks is strictly prohibited.
Contacts:
Medison Pharma
Liat Lavi, VP Corporate Affairs
Immunocore
Sébastien Desprez, VP, Communications
E: sebastien.desprez@immunocore.com
[1] Resolution-RE 407, published in the Brazilian Official Gazette in January 30th, 2025 (Link: https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=03/02/2025&jornal=515&pagina=67)
2https://consultas.anvisa.gov.br/#/bulario/q/?nomeProduto=KIMMTRAK
3https://journals.lww.com/melanomaresearch/fulltext/2019/12000/overall_survival_after_treatment_for_metastatic.1.aspx
4https://pmc.ncbi.nlm.nih.gov/articles/PMC3601161/
5https://pubmed.ncbi.nlm.nih.gov/38392052/