A Phase I Dose-Escalation Safety and Tolerability Study of MirvetuximabSoravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC)

Trial ID # NCT02996825
Phase I
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 Gemcitabine, Mirvetuximab soravtansine
Eligible Participant

FRalpha+ recurrent ovarian, endometrial or triple negative breast cancer with IHC: ≥ 25% tumor cells at ≥ 2+ intensity

Patients Enrolled

22 ovarian treated at RP2D, median 3 prior therapies (3-4), 56% w/ prior bevacizumab, 59% w/ prior PARP inhibitor

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, PFS, RP2D, evaluated per RECIST


RP2D: 6mg/kg mirvetuximab soravtansine q3w and 800mg/m2 gemcitabine days 1 and 8 q3w
Patients dosed at RP2D: 3 low FRalpha+ (IHC: 25-50% at ≥ 2+ intensity), 7 medium FRalpha+ (IHC: 50-75% at ≥ 2+ intensity), 12 high FRalpha+ (IHC: 75-100% at ≥ 2+ intensity)

ORR: 40.9% (9PR, n=22)
DCR: 86.4% (9PR, 10SD, n=22)
PFS: 7.5 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: anemia (11%), decreased lymphocyte counts (16%), decreased neutrophil counts (26%), decreased platelet counts (11%), decreased white cell counts (16%), fatigue (115)


Mirvetuximab soravtansine+gemcitabine can be combined at clinically relevant doses with promising efficacy, particularly in FRalpha med/high tumors


Cristea MC et al. A phase I study of mirvetuximab soravtansine (MIRV) and gemcitabine (G) in patients (Pts) with selected frα-positive solid tumors: Results in the ovarian cancer (EC) cohort. J Clin Oncol (2021) 39 (suppl 15; abstr 5542)

Cristea MC et al. Poster

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