| Trial ID # | NCT02631876; FORWARD I |
| Phase | III |
| 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 | Liposomal doxorubicin, Mirvetuximab soravtansine, Paclitaxel, Topotecan |
| Eligible Participant | Platinum resistant ovarian cancer with 1-3 prior therapies and FRalpha medium/high by 10X score |
| Patients Enrolled | 366; 48% w/ prior bevacizumab |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Randomized |
| Endpoints | ORR, PFS, OS, evaluated per RECIST |
| Biomarkers | FRalpha |
| Efficacy | Mir (n=243) vs Chemotherapy Treatment of Physician's Choice (TPC) (liposomal doxorubicin, paclitaxel or topotecan)(n=109): All patients: FRalpha high (by 10X score; n=218): Exploratory analysis: FRalpha by PS2+ score (score method from prior trials): |
| Clinically Significant Adverse Events | Mir vs TPC: |
| Conclusion | Mirvetuximab soravtansine has favorable tolerability and benefit-risk profile compared to chemotherapy in FRalpha high patients |
| Reference | Moore KN et al. FORWARD I (GOG 3011): A phase III study of mirvetuximab soravtansine, a folate receptor alpha (FRa)-targeting antibody-drug conjugate (ADC), versus chemotherapy in patients (pts) with platinum-resistant ovarian cancer (PROC). ESMO (2019) Abstr 992O ImmunoGen Presents Full Data from Phase 3 FORWARD I Study or Mirvetuximab Soravtansine in Ovarian Cancer at ESMO, press release 9/29/2019 Moore KN et al. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol (2021) 32(6):757-765 |