A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab+Carboplatin in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

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 Carboplatin, Bevacizumab, 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


Study Design

Open-Label, Non-randomized


ORR, DoR, PFS, RP2D, evaluated per RECIST


FRalpha protein



ORR: 71% (3CR, 9PR, n=17)
PFS: 15 months (9.9-NR)


ORR: 81%
DoR: 10.7 months
PFS: 12.0 months

Exploratory analysis, 1 prior therapy:

ORR: 90% (6CR, 22PR, n=31)
DoR: 9.7 months
PFS: 11.9 months

Clinically Significant Adverse Events

Dose limiting toxicities: vasculitis (grade 3)
Serious AE: none
Grade 3-4 AE:
Mir+CarboPt: neutropenia (28%), thrombocytopenia (17%), anemia (11%), hypokalemia (11%);
Mir+CarboPt+Bev: thrombocytopenia (51%); neutropenia (39%); hypertension (10%), grade 2 peripheral neuropathy (22%)


Encouraging activity in FRalpha+ patients


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

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