| Trial ID # | NCT01609556 |
| Phase | I |
| Drug Class | Antibody Drug Conjugates: FRalpha |
| Drug Name | Mirvetuximab soravtansine |
| Alternate Drug Names | Anti-FOLR1-mab Maytansinoid Conjugate, IMGN853, M9346A-sulfo-SPDB-DM4 |
| Drugs in Trial | Mirvetuximab soravtansine |
| Eligible Participant | FRalpha+ platinum resistant cancer; ≤ 5 prior therapies; IHC: ≥ 25% tumor cells at ≥ 2+ intensity |
| Patients Enrolled | 205 (46 ovarian) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, PFS, RP2D, evaluated per RECIST |
| Biomarkers | FRalpha protein |
| Efficacy | RP2D: 6.0mg/kg q3w Exploratory analysis # of prior therapies: Exploratory analysis FORWARD I criteria (Pt-R, ≤3 previous therapies, ≥ 50% of tumor cells with ≥ 2+ FRalpha expression, n=37): |
| Clinically Significant Adverse Events | Serious AE: overall (22%) |
| Conclusion | Promising activity in platinum-resistant FRalpha+ patients |
| Reference | Moore KN et al. Safety and Activity of Mirvetuximab Soravtansine (IMGN853), a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer: A Phase I Expansion Study. J Clin Oncol (2017) 35(10):1112-1118 Moore KN et al. Mirvetuximab soravtansine (IMGN853), a folate receptor alpha (FR⍺)-targeting antibody-drug conjugate (ADC), in platinum-resistant epithelial ovarian cancer (EOC) patients (pts): Activity and safety analyses in phase I pooled expansion cohorts. J Clin Oncol (2017) 35 (suppl; abstr 5547) |