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, 100% w/ prior Bev, 48% w/ prior PARP inhibitor

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, PFS, OS, 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% (5CR, 29PR, n=105)
DCR (3 months): 51.4%
DoR: 6.9 months
PFS: 4.3 months
OS: 15 months

PFS by BICR: 5.5 months

Exploratory analysis: prior therapies:
1-2 prior: ORR: 35.3%; DoR: 5.9 months; OS: 18.7 months
3 prior: ORR: 30.2 %; DoR: 7.0 months; OS: 11.6 months
Mir as first treatment in Pt-R setting (n=66): ORR: 34.8%
Mir as later treatment in Pt-R setting (n=39): ORR: 28.2%
w/ prior Bev in Pt-S setting (n=94): ORR: 34.0% 
w/ prior Bev in Pt-R setting (n=17): ORR: 17.6%

Clinically Significant Adverse Events

Serious AE: overall (9%)
Grade 3-4 AE: overall (29%)

Conclusion

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

Reference

Matulonis UA et al. Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study. J Clin Oncol (2023) 41(13):2436-2445
https://pubmed.ncbi.nlm.nih.gov/36716407/

Coleman RL et al. Mirvetuximab soravtansine (MIRV) in patients with platinum-resistant ovarian cancer with high folate receptor alpha (FRα) expression: Evaluation of sequence of therapy on anti-tumor activity in the SORAYA study. SGO (2023) abstract 19
https://www.clearityfoundation.org/wp-content/uploads/2023/10/Mirv-SORAYA-seq-of-therapy-SGO-2023.pdf

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