| Trial ID # | NCT02606305; FORWARD II |
| Phase | Ib/II |
| 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 | Carboplatin, Mirvetuximab soravtansine |
| Eligible Participant | Platinum sensitive FRalpha+ ovarian cancer; IHC: ≥ 25% tumor cells at ≥ 2+ intensity |
| Patients Enrolled | 200; Mir+CarboPt: 18; median 2.5 prior therapies (1-6) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DoR, PFS, RP2D, evaluated per RECIST |
| Biomarkers | FRalpha protein |
| Efficacy | Mir+CarboPt: |
| Clinically Significant Adverse Events | Dose limiting toxicities: vasculitis (grade 3) |
| Conclusion | The combination of carboplatin and mirvetuximab shows encouraging activity in FRalpha+ platinum sensitive patients |
| Reference | Moore KN et al. Safety and activity findings from a phase Ib escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. Gynecol Oncol (2018) 151: 46-52 O'Malley D et al. Mirvetuximab soravtansine (MIRV), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin (CARBO) and bevacizumab (BEV): Final results from a study in patients (pts) with recurrent platinum sensitive ovarian cancer. Annals Oncol (2020) 31 (suppl_4): abstract 833P |