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 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%
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 (12%), myelosuppression (10%)

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)
https://meetinglibrary.asco.org/record/195544/abstract

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
https://www.immunogen.com/wp-content/uploads/2022/09/IGCS-MIRV-BEV-Oral-Presentation_vF-1.pdf

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