Trial ID # | NCT02606305; FORWARD II-2 |
Phase | Ib/II |
Drug Class | Angiogenesis Inhibitors: VEGF |
Drug Name | Bevacizumab |
Alternate Drug Names | immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin |
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 |