Kimmtrak

Uveal melanoma — HLA-A*02:01-positive adults with unresectable or metastatic disease

Week 1: 20 mcg IV
Week 2: 30 mcg IV
Week 3 and beyond: 68 mcg IV weekly until disease progression or unacceptable toxicity
Infuse over 15-20 minutes
HLA-A*02:01 testing required before initiation (FDA-approved test)
Monitoring: Inpatient or outpatient with overnight post-dose monitoring for first 3 infusions, extended monitoring through first 4 infusions recommended

Injection: 100 mcg/0.5 mL solution in single-dose vial

None listed.

• Cytokine Release Syndrome (CRS): 89% (0.5% Grade ≥3). Median onset: hours after infusion. Manage with supportive care; severe cases with IV fluids and corticosteroids. Do not reduce dose for CRS.
• Skin Reactions: 91% (Grade ≥3: 0.7%). Rash, pruritus, cutaneous edema. Related to gp100 expression in melanocytes.
• Elevated Liver Enzymes: 65% (Grade ≥3: 3%). Monitor LFTs before each infusion for first 3 doses, then before each dose as indicated.
• Embryo-Fetal Toxicity

CRS (89%), rash (83%), pyrexia (76%), pruritus (69%), fatigue (51%), nausea (45%), chills (43%), abdominal pain (33%), edema (30%), hypotension (29%), dry skin (26%), headache (24%), vomiting (24%)

CRS in 89% (Grade 3+ in 1%). Skin reactions in 91% (rash 83%, pruritus 69%, edema 42%). Elevated LFTs in 65% (Grade 3+ in 3%). Permanently D/C for Grade 4 irAEs.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

CRS in 89% (Grade 3+ in 1%). Skin reactions in 91% (rash 83%, pruritus 69%, edema 42%). Elevated LFTs in 65% (Grade 3+ in 3%). Permanently D/C for Grade 4 irAEs.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T-cell engager. It consists of a high-affinity T-cell receptor (TCR) fused to an anti-CD3 single-chain variable fragment (scFv). The TCR domain recognizes gp100₂₈₀₋₂₈₈ peptide presented by HLA-A*02:01 on tumor cells. The anti-CD3 domain engages T cells, forming a synapse between T cells and gp100-positive tumor cells, leading to T-cell activation, cytokine release, and target cell lysis. It is the first TCR-based bispecific therapy approved.

Half-life: approximately 7-9 hours. Tmax: end of infusion. Clearance: 1.4 L/h. Vd: 9.6 L. Rapid distribution and elimination due to small bispecific format. Steady-state not typically achieved (weekly dosing with short t½).

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• IMCgp100-202 — Tebentafusp vs. investigator's choice in HLA-A*02:01+ metastatic uveal melanoma. Phase III, n=378.
  🔬 NCT03070392 ↗ 📄 Primary Publication ↗

Kimmtrak has FDA-approved indications across the following cancer types covered on PipelineEvidence: