Phase 3
N=453
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression
Epithelial Ovarian Cancer · Peritoneal Cancer · Fallopian Tube Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04209855 ↗Enrolled (actual)
453
Serious AEs
29.8%
Results posted
Aug 2024
Primary outcome: Primary: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — 5.59; 3.98 months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mirvetuximab Soravtansine (Drug); Paclitaxel (Drug); Topotecan (Drug); Pegylated liposomal doxorubicin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AbbVie
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
5.59; 3.98 | <0.0001 sig |
| SECONDARY Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1 |
41.9; 15.9 | — |
| SECONDARY Overall Survival Assessed by the Investigator Using RECIST v1.1 |
16.85; 13.34 | — |
| SECONDARY Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28) |
34; 23 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
211; 194 | — |
| SECONDARY Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 |
6.93; 4.44 | — |
| SECONDARY Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria |
58.0; 30.1 | — |
| SECONDARY Time to Second Progression-Free Survival (PFS 2) |
11.01; 7.59 | — |
Summary
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.
Eligibility Criteria
Inclusion Criteria
- Female participants ≥ 18 years of age
- Participants must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Participants must have platinum-resistant disease:
- Participants who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between >3 months and ≤ 6 months after the date of the last dose of platinum
- Participants who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. Note: Participants who are platinum-refractory during front-line treatment are excluded
- Participants must have progressed radiographically on or after their most recent line of therapy
- Participants must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity
- Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
- Participants must have at least one lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (radiologically measured by the Investigator)
- Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:
- Adjuvant ± neoadjuvant considered one line of therapy
- Maintenance therapy (for example, bevacizumab, poly (ADP-ribose) polymerase [PARP] inhibitors) will be considered as part of the preceding line of therapy (that is, not counted independently)
- Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (that is, not counted independently)
- Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
- Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Time from prior therapy:
- Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)
- Focal radiation completed at least 2 weeks prior to first dose of study drug
- Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities
- Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery
- Participants must have adequate hematologic, liver and kidney functions defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/liter (L) (1,500/microliter [μL]) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 20 days
- Platelet count ≥ 100 x 10^9/L (100,000/μL) without platelet transfusion in the prior 10 days
- Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
- Serum bilirubin ≤ 1.5 x ULN (participants with documented diagnosis of Gilbert syndrome are eligible if total bilirubin Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edem
Data sourced from ClinicalTrials.gov (NCT04209855). 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.