Phase 3
Completed N=366
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer
Source: ClinicalTrials.gov NCT02631876 ↗Enrolled (actual)
366
Serious AEs
27.8%
Results posted
Jun 2020
Primary outcomePrimary: Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study — 4.14; 4.44 months
◆ Published Evidence
Highly cited
286citations · ~57 / year
Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I.
Summary
This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.
Linked Publications
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Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study |
4.14; 4.44 | — |
| PRIMARY PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining) |
4.76; 3.25 | — |
| SECONDARY Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1 |
22; 12 | — |
| SECONDARY Overall Survival (OS) |
15.57; 13.93 | — |
| SECONDARY Number of Participants Achieving at Least a 15% (≥ 15-Point) Absolute Improvement From Baseline on the EORTC QLQ-OV28 Abdominal/Gastrointestinal (AB/GI) Symptom Subscale at Week 8/9 Assessment |
45; 7 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
242; 107 | — |
| SECONDARY Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses |
51; 27 | — |
| SECONDARY PFS, as Assessed by Investigator Per RECIST Version 1.1 |
4.27; 4.24 | — |
| SECONDARY Duration of Response (DOR), as Assessed by BIRC Per RECIST v1.1 |
5.65; 7.26 | — |
| SECONDARY Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4 |
20.53; 22.40; 23.23; 31.20; 348.5; 347.4 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies (ADA) |
13 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must be diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
- Participants must have folate receptor alpha positive tumor expression as defined in the protocol
- Participants must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy.
- Participants must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment
- Participants must have at least one lesion that meets the definition of measurable disease by RECIST 1.1
Exclusion Criteria
- Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
- Participants with primary platinum-refractory disease
- Serious concurrent illness or clinically relevant active infection as defined in the protocol
- Prior treatment with mirvetuximab soravtansine
- Women who are pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT02631876) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.