| Trial ID # | NCT02606305; FORWARD II-2 |
| Phase | Ib/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 | Bevacizumab, Mirvetuximab soravtansine |
| Eligible Participant | Platinum sensitive FRalpha+ ovarian cancer; IHC: ≥ 25% tumor cells at ≥ 2+ intensity |
| Patients Enrolled | 31 |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DoR, PFS, evaluated per RECIST |
| Biomarkers | Exploratory analysis: FRalpha high (IHC: ≥ 75% tumor cells at ≥ 2+ intensity) |
| Efficacy | ORR: 48% Exploratory analysis, FRalpha high (n=16): |
| Clinically Significant Adverse Events | Serious AE: |
| Conclusion | The combination of mirvetuximab soravtansine with bevacizumab demonstrates an encouraging ORR in platinum sensitive patients with high FRalpha expression |
| Reference | O'Malley DM et al. Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients (pts) with platinum-agnostic ovarian cancer: Final analysis. J Clin Oncol (2021) 39 (suppl 15; abstr 5504) O'Malley DM et al. Mirvetuximab Soravtansine and Bevacizumab in Folate Receptor Alpha-Positive Ovarian Cancer: Efficacy in Patients With and Without Prior Bevacizumab. IGCS 2022, presentation |