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 M9346A-sulfo-SPDB-DM4, IMGN853, Anti-FOLR1-mab Maytansinoid Conjugate
Drugs in Trial Bevacizumab, Mirvetuximab soravtansine
Eligible Participant

Recurrent FRalpha+ ovarian cancer; IHC: ≥ 50% tumor cells at ≥ 2+ intensity

Patients Enrolled

60 patients, median 2 prior therapies (1-4); 47% Pt-S, 53% Pt-R; 40% w/ prior bevacizumab

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DoR, PFS, evaluated per RECIST

Biomarkers

FRalpha+

Efficacy

ORR: 50%; DoR: 9.7 months; PFS: 8.3 months
FRalpha medium (IHC: ≥ 50% tumor cells at ≥ 2+ intensity, n=27): ORR: 33%; DoR: 8.3 months; PFS: 5.4 months
FRalpha high (IHC: ≥ 75% tumor cells at ≥ 2+ intensity, n=33): ORR: 64%; DoR: 11.8 months; PFS: 10.6 months

Exploratory analysis, Pt-status in FRalpha high patients:
Pt-S (n=16): ORR: 69%; DoR: 12.7 months; PFS: 13.3 months
Pt-R (n=17): ORR: 59%; DoR: 9.4 months; PFS: 9.7 months

Clinically Significant Adverse Events

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

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

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