Detalle Publicación

MIRVETUXIMAB SORAVTANSINE AND CARBOPLATIN FOR TREATMENT OF PATIENTS WITH RECURRENT FOLATE RECEPTOR ALPHAPOSITIVE PLATINUM-SENSITIVE OVARIAN CANCER: A FINAL ANALYSIS

Autores: Moore, K.; O'Malley, D.; Vergote, I.; Martín, L.; González Martín, Antonio; Wang, J.; Method, M.; Birrer, M.
Título de la revista: INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER
ISSN: 1048-891X
Volumen: 32
Número: SUPPL 3
Páginas: A33 - A34
Fecha de publicación: 2022
Resumen:
Objectives Mirvetuximab soravtansine (MIRV) is a first-in-class ADC comprising a folate receptor-¿ (FR¿)-binding antibody, cleavable linker, and maytansinoid DM4 payload. As part of the phase 1b/2 trial (NCT02606305), efficacy and safety of MIRV and carboplatin (carbo) were evaluated in patients with recurrent FR¿-positive platinum sensitive ovarian cancer (PSOC) measured by immunohistochemistry (PS2+ ¿25%; table 1). Methods Eighteen patients received MIRV and carbo intravenously on Day 1 of a 3-week cycle using a standard 3 + 3 design, with a starting dose of MIRV 5 mg/kg adjusted ideal body weight (AIBW) and carbo AUC4. FR¿ positivity by immunohistochemistry (PS2+ ¿25%) was required. Primary endpoint was confirmed ORR by RECIST v1.1. Results Ten patients received MIRV 6 mg/kg AIBW and carbo AUC5. Anti-tumor activity was observed in all dose escalation cohorts with varying levels of FR¿ expression. Patients receiving MIRV 6 mg/kg AIBW and carbo AUC5 had an ORR of 89%, mDOR of 12.1, and mPFS of 16.5 months. Patients with medium/high FR¿-expressing tumors had an ORR of 80%, mDOR of 24.2, and mPFS of 15.0 months across all escalation cohorts (table 2). The most frequent treatment-emergent adverse events (all, grade 3+) included nausea (72%, 0%), diarrhea (67%, 6%), blurred vision (67%, 0%), thrombocytopenia (61%, 17%), fatigue (61%, 11%), and neutropenia (56%, 28%). Conclusions MIRV and carbo demonstrated anti-tumor activity in patients with recurrent FR¿-positive PSOC. MIRV 6 mg/kg AIBW and carbo AUC5 was selected as the phase 2 dose. This combination is being evaluated in one planned and two ongoing (NCT04606914 and NCT04274426) studies.
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