Trial ID # | NCT02606305; FORWARD II |
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 resistant FRalpha+ ovarian cancer; IHC: ≥ 25% tumor cells at ≥ 2+ intensity |
Patients Enrolled | 94; median 3 prior therapies; 59% w/ prior bevacizumab, 27% w/ prior PARPi |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, DoR, PFS, RP2D, evaluated per RECIST |
Biomarkers | FRalpha protein |
Efficacy | RP2D: Bev 15 mg/kg + Mir 6 mg/kg q3w ORR: 44% (5CR, 36PR:, n=94) Exploratory analysis; FRalpha levels, prior Bev: |
Clinically Significant Adverse Events | Serious AE: one Bev-related death (intestinal perforation) |
Conclusion | The mirvetuximab soravtansine plus bevacizumab doublet is an active and well-tolerated regimen in patients with FRα-expressing platinum-resistant ovarian cancer. Promising activity was observed for patients regardless of level of FRα expression or prior bevacizumab |
Reference | O'Malley DM et al. Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. Gynecol Oncol (2020) 157(2):379-385 Gilbert L et al. Safety and efficacy of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. Gynecol Oncol (2023) 170:241-247 |