Patient eligibility
The goal of overall survival in metastatic uveal melanoma
- Up to 50% of patients like Elizabeth and Dave with uveal melanoma (UM) will develop metastatic disease2,3
- mUM has historically dismal prognosis after metastasis, with a median survival of approximately 9-16 months3-6
Systemic metastases retain the immune privilege characteristics that originated in the eye7
Hepatic only mUM: Patient1
Elizabeth, 70 years
HLA STATUS: HLA-A*02:01+
Elizabeth is a retired teacher who enjoys tutoring high school–level math at her local library. When routine imaging revealed her disease had spread, Elizabeth wanted to know the 1L treatment option that best fits her primary treatment goal of more time with her students.
Time since primary diagnosis: 4.5 years
ECOG PS: 0
Baseline LDH: 210 U/L
Location of metastases: Liver
Largest metastatic lesion at baseline: 7.2 cm
This is a fictitious patient profile and is not representative of all patients. The profile is intended to be used for education and illustrative purposes only.
Early intervention with KIMMTRAK 1L provides the best opportunity to receive the overall survival benefit seen in the pivotal trial.8,9
Hepatic + Extrahepatic mUM: Patient2
Dave, 61 years
HLA STATUS: HLA-A*02:01+
Dave is married with 3 children, and his first grandchild is on the way. Since his primary diagnosis in 2024, Dave has learned that his disease has spread. Dave wants as much time as possible with his family, and to select the 1L treatment that is best for him.
Time since primary diagnosis: 2 years
ECOG PS: 1
Baseline LDH: 350 U/L
Location of metastases: Liver, lung, and bone
Largest metastatic lesion at baseline:
9.1 cm (hepatic lesion)
This is a fictitious patient profile and is not representative of all patients. The profile is intended to be used for education and illustrative purposes only.
for patients like Elizabeth and Dave who were included in the phase 3 clinical trial
NCCN Guidelines® recommend a blood test to determine HLA status for metastatic uveal melanoma patients like Elizabeth and Dave to inform their 1L treatment decisions.11
- ECOG PS, Eastern Cooperative Oncology Group Performance Status; HLA, human leukocyte antigen; LDH, lactate dehydrogenase.
- *Based on Komodo US medical claims from February 2022 through July 2024 and calibrated with actual vials sold.1
- †Investigator's choice: checkpoint inhibitors (pembrolizumab and ipilimumab) or chemotherapy (dacarbazine).8
Indication
Important Safety Information Including Boxed Warning
KIMMTRAK is 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.