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 | Bevacizumab, Carboplatin, Mirvetuximab soravtansine |
Eligible Participant | Platinum sensitive FRalpha+ ovarian cancer; IHC: ≥ 25% tumor cells at ≥ 2+ intensity (Mir+CarboPt), IHC: ≥ 50% of tumor cells at 2+ intensity (Mir+CarboPt+Bev) |
Patients Enrolled | 200 [Mir+CarboPt: 18; median 2.5 prior therapies (1-6); Mir+CarboPt+Bev: 41, median 1 prior therapy (1-2 prior)] |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, DoR, PFS, RP2D, evaluated per RECIST |
Biomarkers | FRalpha protein |
Efficacy | Mir+CarboPt: Mir+CarboPt+Bev: Exploratory analysis, 1 prior therapy: |
Clinically Significant Adverse Events | Dose limiting toxicities: vasculitis (grade 3) |
Conclusion | Encouraging activity in FRalpha+ 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 |