Safety
Most common adverse reactions reported
In clinical trials, cytokine release syndrome (CRS), skin reactions, and elevated liver enzymes have occurred following KIMMTRAK infusion.1 These events decreased in frequency and severity following each subsequent KIMMTRAK infusion.1,2
- aRepresents algorithmic identification of CRS cases based on American Society for Transplant and Cellular Therapy (ASTCT) grading criteria (Lee et al. 2019).1
- bRepresents a composite of multiple related terms.1
Clinically relevant adverse reactions occurring in <20% of patients who received KIMMTRAK included back pain, decreased appetite, constipation, hypertension, tachycardia or sinus tachycardia, dyspnea, paresthesia, dizziness, flushing, muscle spasms, myalgia, pain in extremity, alopecia, skin hyperpigmentation, influenza-like illness, oropharyngeal pain, and night sweats.1
PRIMARY ANALYSIS: Low 3.3% discontinuation rate with
KIMMTRAK due to treatment-emergent adverse events1
Incidence of select treatment-related adverse events by week during treatment with KIMMTRAK in the primary analysis2
CRS represents algorithmic identification of cases based on ASTCT grading criteria (Lee et al. 2019). Rash represents a composite of multiple related terms.1
From New England Journal of Medicine, Nathan P, et al, Overall survival benefit with tebentafusp in metastatic uveal melanoma, Volume 385, Page 1204. Copyright © 2021 Massachusetts Medical Society. Adapted with permission from Massachusetts Medical Society.2
No treatment-related deaths were reported; 1 treatment-emergent death was reported with KIMMTRAK.2,4
3-YEAR FOLLOW-UP ANALYSIS:
No new safety signals were identified3
KIMMTRAK treatment-related adverse events were predictable and manageable,* decreasing in frequency and severity after the first 3 doses1,3
The numbers of patients at risk for each time interval are indicated. Rash, hypotension, and liver-function tests (ie, elevated liver-function values) are composite terms for a list of related adverse events of any grade.
From New England Journal of Medicine, Hassel JC, et al, Three-year overall survival with tebentafusp in metastatic uveal melanoma, Volume 389, Page 9. Copyright © 2023 Massachusetts Medical Society. Adapted with permission from Massachusetts Medical Society.
Low 3.2% discontinuation rate with KIMMTRAK due to treatment-emergent adverse events.4
No treatment-related deaths were reported; 3 treatment-emergent deaths were reported with KIMMTRAK.3,5
- *CRS symptoms were generally reversible and managed with IV fluids, NSAIDs, corticosteroids, oxygen, and rarely, a vasopressor. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy.1,2
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.