| Trial ID # | NCT05041257; PICCOLO |
| Phase | II |
| Drug Class | Antibody Drug Conjugates: FRalpha |
| Drug Name | Mirvetuximab soravtansine |
| Alternate Drug Names | M9346A-sulfo-SPDB-DM4, IMGN853, Anti-FOLR1-mab Maytansinoid Conjugate |
| Drugs in Trial | Mirvetuximab soravtansine |
| Eligible Participant | Platinum sensitive high grade serous FRalpha high+ ovarian cancer with at least 2 prior platinum regimens; at most 1 non-platinum regimen; patients with BRCA1/2 mutations must have had prior PARP inhibitor |
| Patients Enrolled | 79, median 2 prior therapies; 81% w/ prior PARP inhibitor, 65% w/ prior bevacizumab |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, DoR, PFS, evaluated per RECIST |
| Biomarkers | FRalpha-high: ≥ 75% of tumor cells with FRα membrane staining and ≥ 2+ intensity by immunohistochemistry (IHC) using the Ventana FOLR1 (FOLR1 2.1) CDx assay |
| Efficacy | Mirvetuximab demonstrates clinically meaningful anti-tumor activity and favorable tolerability in patients with FRα-high platinum sensitive ovarian cancer. The efficacy and safety data support the use of mirvetuximab in platinum sensitive patients with ≥ 2 prior platinum-containing regimens or platinum allergy ORR: 51.9% (6CR, 35PR) Exploratory analysis; prior PARP inhibitor: |
| Clinically Significant Adverse Events | Serious AE: overall ( 9%) |
| Conclusion | Mirvetuximab demonstrates clinically meaningful anti-tumor activity and favorable tolerability in patients with FRα-high platinum sensitive ovarian cancer. The efficacy and safety data support the use of mirvetuximab in platinum sensitive patients with ≥ 2 prior platinum-containing regimens or platinum allergy |
| Reference | Secord AA et al. Mirvetuximab soravtansine (MIRV) in recurrent platinum-sensitive ovarian cancer (PSOC) with high folate receptor-alpha (FRα) expression: Results from the PICCOLO trial. Ann Oncol (2024) 35 (2) abstract 718MO |