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Important Safety Information
Prescribing Information
Patient Site
KIMMTRAK CONNECT
See 3-YEAR follow-up data1

mUM burden

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Metastatic uveal melanoma (mUM) has significant unmet need1-7

Up to 50% of patients with uveal melanoma (UM) will develop metastatic disease1,2

  • In 90% of cases, the liver is the primary location of metastasis1
  • Up to 800-1000 mUM cases are identified in the US each year1-4
mUM has a historically dismal prognosis after metastasis, with a median survival of approximately 9-16 months2,5-7

Until 2022, patients with mUM faced a poor prognosis, with no FDA-approved treatments.2,5-7

Although both arise from melanocyte transformation, mUM and
metastatic cutaneous melanoma (mCM) are biologically distinct1,3,5,8

UM cells engage distinct mechanisms that enable evasion of immune surveillance5,8,9

UM has one of the lowest tumor mutational burdens (TMB), which is associated with low response to checkpoint inhibitor monotherapy.5,8,10,11

Correlation between TMB and objective response rate (ORR) with anti-PD-1/PD-L1 therapy in 27 tumor types10
A chart showing the differences in response to checkpoint inhibitor monotherapy between mUM and mCM
Pinch to zoom

KIMMTRAK is not approved for use in mCM.

  • *The number of patients evaluated (ORR) was 50 for UM and 1000 for cutaneous melanoma (CM); the number of tumors analyzed (TMB) was 100 for UM and 1000 for CM.

Immunotherapies shown to improve outcomes in mCM have not been proven to do the same for patients with mUM.1-3,5,6,8

A comparison chart showing the key differences between mUM and mCMA comparison chart showing the key differences between mUM and mCM

Neither checkpoint inhibitors nor other systemic therapies used to treat mCM are FDA approved in mUM.12,13,20

HLA, human leukocyte antigen; OS, overall survival.

Indication
 
Important Safety Information Including Boxed Warning

KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

WARNING: CYTOKINE RELEASE SYNDROME
Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated.

Indication and Important Safety Information Including Boxed Warning

Indication

KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Important Safety Information Including Boxed Warning

WARNING: CYTOKINE RELEASE SYNDROME
Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

Skin ReactionsSkin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

Elevated Liver Enzymes Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.

Embryo-Fetal ToxicityKIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.

The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.

Please see full Prescribing Information, including BOXED WARNING for CRS.

References:
1. Carvajal RD, Schwartz GK, Tezel T, et al. Metastatic disease from uveal melanoma: treatment options and future prospects. Br J Ophthalmol. 2017;101(1):38-44. doi:10.1136/bjophthalmol-2016-309034 2. Yang J, Manson DK, Marr BP, Carvajal RD. Treatment of uveal melanoma: where are we now? Ther Adv Med Oncol. 2018;10:1758834018757175. doi:10.1177/1758834018757175 3. Jovanovic P, Mihajlovic M, Djordjevic-Jocic J, et al. Ocular melanoma: an overview of the current status. Int J Clin Exp Pathol. 2013;6(7):1230-1244 4. About ocular melanoma. Ocular Melanoma Foundation. Accessed July 6, 2021. http://www.ocularmelanoma.org/about-om.htm 5. Pandiani C, Béranger GE, Leclerc J, Ballotti R, Bertolotto C. Focus on cutaneous and uveal melanoma specificities. Genes Dev. 2017;31(8):724-743. doi:10.1101/gad.296962.117 6. Rantala ES, Hernberg M, Kivelä TT. Overall survival after treatment for metastatic uveal melanoma: a systematic review and meta-analysis. Melanoma Res. 2019;29(6):561-568. doi:10.1097/CMR.0000000000000575 7. Khoja L, Atenafu EG, Suciu S, et al. Meta-analysis in metastatic uveal melanoma to determine progression free and overall survival benchmarks: an International Rare Cancers Initiative (IRCI) ocular melanoma study. Ann Oncol. 2019;30(8):1370-1380. doi:10.1093/annonc/mdz176 8. Nathan P, Hassel JC, Rutkowski P, et al; IMCgp100-202 Investigators. Overall survival benefit with tebentafusp in metastatic uveal melanoma. N Engl J Med. 2021;385(13):1196-1206. doi:10.1056/NEJMoa2103485 9. Niederkorn JY. Ocular immune privilege and ocular melanoma: parallel universes or immunological plagiarism? Front Immunol. 2012;3:148. doi:10.3389/fimmu.2012.00148 10. Yarchoan M, Hopkins A, Jaffee EM. Tumor mutational burden and response rate to PD-1 inhibition. N Engl J Med. 2017;377(25):2500-2501. doi:10.1056/NEJMc1713444 11. Damato BE, Dukes J, Goodall H, Carvajal RD. Tebentafusp: T cell redirection for the treatment of metastatic uveal melanoma. Cancers (Basel). 2019;11(7):971. doi:10.3390/cancers11070971 12. Kimmtrak. Package insert. Immunocore Ltd; 2022. 13. FDA Approved Drugs. Aim at Melanoma Foundation. Accessed April 8, 2024. https://www.aimatmelanoma.org/how-melanoma-is-treated/fda-approved-drugs/ 14. Eisenstein A, Gonzalez EC, Raghunathan R, et al. Emerging biomarkers in cutaneous melanoma. Mol Diagn Ther. 2018;22(2):203-218. doi:10.1007/s40291-018-0318-zb 15. Beadling C, Jacobson-Dunlop E, Hodi FS, et al. KIT gene mutations and copy number in melanoma subtypes. Clin Cancer Res. 2008;14(21):6821-6828. doi:10.1158/1078-0432.CCR-08-0575 16. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2019;381(16):1535-1546. doi:10.1056/NEJMoa1910836 17. Hamid O, Robert C, Daud A, et al. Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Ann Oncol. 2019;30(4):582-588. doi:10.1093/annonc/mdz011 18. Sandru A, Voinea S, Panaitescu E, Blidaru A. Survival rates of patients with metastatic malignant melanoma. J Med Life. 2014;7(4):572-576. 19. Franken MG, Leeneman B, Aarts MJB, et al. Trends in survival and costs in metastatic melanoma in the era of novel targeted and immunotherapeutic drugs. ESMO Open. 2021;6(6):100320. doi:10.1016/j.esmoop.2021.100320 20. National Library of Medicine. DailyMed. Accessed April 8, 2024. https://dailymed.nlm.nih.gov/dailymed/index.cfm