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-2
Phase Ib/II
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 Bevacizumab, Mirvetuximab soravtansine
Eligible Participant

Platinum sensitive FRalpha+ ovarian cancer; IHC: ≥ 25% tumor cells at ≥ 2+ intensity

Patients Enrolled


Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DoR, PFS, evaluated per RECIST


Exploratory analysis: FRalpha high (IHC: ≥ 75% tumor cells at ≥ 2+ intensity)


ORR: 48%
DoR: 12.7 months
PFS: 9.6 months

Exploratory analysis, FRalpha high (n=16):
ORR: 69%; DoR: 12.7 months; PFS: 13.3 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: hypertension (17%), neutropenia (13%)


The combination of mirvetuximab soravtansine with bevacizumab demonstrates an encouraging ORR in platinum sensitive patients with high FRalpha expression


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

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