SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

Trial ID # NCT04296890; SORAYA
Phase III
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 Mirvetuximab soravtansine
Eligible Participant

Platinum resistant FRalpha+ ovarian cancer with prior bevacizumab

Patients Enrolled

106, median 3 prior therapies (1-4), 100% w/ prior Bev, 48% w/ prior PARP inhibitor

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DoR, evaluated per RECIST

Biomarkers

FRalpha-high: ≥ 75% of tumor cells with FRα membrane staining and ≥ 2+ intensity by immunohistochemistry (IHC) using the Ventana FOLR1 (FOLR1 2.1) CDx assay

Efficacy

ORR: 32.4%
DoR: 6.9 months
PFS: 4.3 months

Exploratory analysis: number of prior therapies:
1-2 prior: ORR: 35.3%; DoR: 5.9 months
3 prior: ORR: 30.2 %; DoR: 7.0 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: overall 28%

Conclusion

Mirvetuximab shows impressive activity and tolerability in FRα-high platinum resistant ovarian cancer

Reference

ImmunoGen Announces Positive Top-Line Results from Pivotal SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer, Press Release, 11/30/21
https://investor.immunogen.com/news-releases/news-release-details/immunogen-announces-positive-top-line-results-pivotal-soraya

SGO 2022, slide from presentation, scientific plenary IV, abstract 242
https://www.clearityfoundation.org/wp-content/uploads/2022/04/SGO-2022-SORAYA-slide-from-presentation.pdf

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