Product information and disease descriptionPlace of product in therapyApproaches to treatment
Care management intervention strategies
5 evidence topics · 9 sources
Summary: care management for R/M ACC and anticipated monitoring with emiltatug ledadotin
Guidelines recommend multidisciplinary management in specialized head and neck units, tumor sequencing at the time of recurrent or metastatic disease, and consideration of clinical trial participation, including NOTCH inhibitor trials for tumors with activating NOTCH mutations. Patients with residual, recurrent, or metastatic disease are imaged 2 to 4 times per year, with lower frequency when growth is slow, and systemic therapy is initiated on defined symptomatic or growth criteria. During VEGFR tyrosine kinase inhibitor therapy, dose modification is frequent (85.0% with rivoceranib; 23 of 32 participants with lenvatinib; 32 of 51 participants, 63.6%, in a real-world lenvatinib cohort), and hypertension, stomatitis, fatigue, and bleeding events require monitoring, including one fatal drug-related bleeding in the real-world cohort. For emiltatug ledadotin, the most common grade 3 treatment-related adverse events in the phase 1 analysis were AST increase (20%) and proteinuria (23%), which indicates a need for liver enzyme and urine protein monitoring; treatment-related adverse events led to discontinuation in 3.9% of participants.
Imaging surveillance and multidisciplinary follow-up
Molecular testing to guide trial eligibility
Adverse event management during VEGFR tyrosine kinase inhibitor therapy
Emiltatug ledadotin: adverse events relevant to monitoring
| Field | Registry record |
|---|---|
| Exclusion criterion | “Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.” |
| Exclusion criterion | “Prior B7-H4 targeted treatment.” |
| Exclusion criterion | “Active keratitis (inflammation of the cornea of the eye)” |