Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Conditions
Keywords
Platinum-resistant, Folate-receptor alpha expression, Phase 3, Antibody-drug conjugate, mirvetuximab soravtansine, IMGN853, Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Brief 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.
Detailed description
Participants will be randomized to either MIRV or IC chemotherapy (paclitaxel, PEGylated liposomal doxorubicin, or topotecan).
Interventions
DRUGMirvetuximab Soravtansine
Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.
DRUGPaclitaxel
Paclitaxel will be administered per dose and schedule specified in the arm.
DRUGTopotecan
Topotecan will be administered per dose and schedule specified in the arm.
DRUGPegylated liposomal doxorubicin
Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.
Sponsors
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female participants ≥ 18 years of age 2. Participants must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer 3. Participants must have platinum-resistant disease: 1. 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 2. 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 4. Participants must have progressed radiographically on or after their most recent line of therapy 5. 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 6. Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay 7. 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) 8. 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: 1. Adjuvant ± neoadjuvant considered one line of therapy 2. 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) 3. Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (that is, not counted independently) 4. Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance 9. Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 10. Time from prior therapy: 1. Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter) 2. Focal radiation completed at least 2 weeks prior to first dose of study drug 11. Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities 12. 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 13. Participants must have adequate hematologic, liver and kidney functions defined as: 1. 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 2. Platelet count ≥ 100 x 10\^9/L (100,000/μL) without platelet transfusion in the prior 10 days 3. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 6. Serum bilirubin ≤ 1.5 x ULN (participants with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN 7. Serum albumin ≥ 2 grams (g)/deciliter (dL) 14. Participants or their legally authorized representative must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements 15. Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on study drug and for at least 3 months after the last dose of MIRV or at least 6 months after the last dose of paclitaxel, pegylated liposomal doxorubicin, or topotecan 16. WCBP must have a negative pregnancy test within 4 days prior to the first dose of study drug
Exclusion criteria
1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor 2. Participants with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy 3. Participants with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow 4. Participants with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 5. 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 edema, macular degeneration, presence of papilledema, and /or monocular vision 6. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following: 1. Active hepatitis B or C infection (whether or not on active antiviral therapy) 2. Human immunodeficiency virus (HIV) infection 3. Active cytomegalovirus infection 4. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before starting study drug Note: Testing at screening is not required for the above infections unless clinically indicated 7. Participants with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome) 8. Participants with clinically significant cardiac disease including, but not limited to, any one of the following: 1. Myocardial infarction ≤ 6 months prior to first dose 2. Unstable angina pectoris 3. Uncontrolled congestive heart failure (New York Heart Association \> class II) 4. Uncontrolled ≥ Grade 3 hypertension (per CTCAE) 5. Uncontrolled cardiac arrhythmias 9. Participants assigned to PLD stratum only: Left ventricular ejection fraction (LVEF) below the institutional limit of normal as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan 10. Participants with a history of hemorrhagic or ischemic stroke within six months prior to randomization 11. Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C) 12. Participants with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis 13. Participants with required use of folate-containing supplements (for example, folate deficiency) 14. Participants with prior hypersensitivity to monoclonal antibodies 15. Women who are pregnant or lactating 16. Participants with prior treatment with MIRV or other FRα-targeting agents 17. Participants with untreated or symptomatic central nervous system (CNS) metastases 18. Participants with a history of other malignancy within 3 years prior to randomization. Note: does not include tumors with a negligible risk for metastasis or death (for example, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast 19. Prior known hypersensitivity reactions to study drugs and/or any of their excipients 20. People who are detained through a court or administrative decision, receiving psychiatric care against their will, adults who are the subject of a legal protection order (under tutorship/curatorship), people who are unable to express their consent, and people who are subject to a legal guardianship order 21. Simultaneous participation in another research study, in countries or localities where this is the health authority guidance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From randomization until PD or death, whichever occurred first (up to approximately 36 months) | PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Assessed by the Investigator Using RECIST v1.1 | Up to approximately 45 months | Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method. |
| 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) | Baseline and Week 8 or 9 | The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher (better) level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 37 months | An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 36 months | ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD. |
| Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Baseline up to approximately 36 months | The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days. |
| Time to Second Progression-Free Survival (PFS 2) | Up to approximately 44 months | PFS 2 was defined as the time from date of randomization until second disease progression or death whichever occurred first. |
| Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | Up to approximately 34 months | DOR was defined as the time from the date of the first response (CR or PR), until the date of PD or death from any cause, whichever occurred first. DOR for participants who have not progressed or died at the time of analysis are censored at the date of their last tumor assessment. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also have demonstrated an absolute increase of at least 5 mm. DOR was estimated using the Kaplan-Meier method. |
Countries
Australia, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Russia, Serbia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 453 participants were randomized to a treatment group and included in the Intent-to-Treat (ITT) population. 425 participants received at least 1 dose of study drug and were included in the Safety Population.
Participants by arm
| Arm | Count |
|---|---|
| Mirvetuximab Soravtansine Participants received single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W. | 227 |
| Investigator's Choice (IC) Chemotherapy Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion. | 226 |
| Total | 453 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 161 | 177 |
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Other than specified | 6 | 4 |
| Overall Study | PI Discretion | 1 | 1 |
| Overall Study | Sponsor decision | 44 | 18 |
| Overall Study | Withdrew consent | 10 | 24 |
Baseline characteristics
| Characteristic | Investigator's Choice (IC) Chemotherapy | Total | Mirvetuximab Soravtansine |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 9.3 | 62.8 years STANDARD_DEVIATION 9.58 | 63.3 years STANDARD_DEVIATION 9.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 27 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 163 Participants | 340 Participants | 177 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 48 Participants | 86 Participants | 38 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 53 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 51 Participants | 86 Participants | 35 Participants |
| Race (NIH/OMB) White | 145 Participants | 301 Participants | 156 Participants |
| Sex: Female, Male Female | 226 Participants | 453 Participants | 227 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 162 / 227 | 177 / 226 |
| other Total, other adverse events | 212 / 227 | 196 / 226 |
| serious Total, serious adverse events | 62 / 227 | 73 / 226 |
Outcome results
Primary
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time frame: From randomization until PD or death, whichever occurred first (up to approximately 36 months)
Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mirvetuximab Soravtansine | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 5.59 months |
| Investigator's Choice (IC) Chemotherapy | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 3.98 months |
p-value: <0.000195% CI: [0.513, 0.785]Log Rank
Secondary
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
DOR was defined as the time from the date of the first response (CR or PR), until the date of PD or death from any cause, whichever occurred first. DOR for participants who have not progressed or died at the time of analysis are censored at the date of their last tumor assessment. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also have demonstrated an absolute increase of at least 5 mm. DOR was estimated using the Kaplan-Meier method.
Time frame: Up to approximately 34 months
Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, Overall number of participants analyzed is the number of evaluable participants for this outcome measure who had CR or PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mirvetuximab Soravtansine | Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | 6.93 months |
| Investigator's Choice (IC) Chemotherapy | Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | 4.44 months |
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)
The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher (better) level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28.
Time frame: Baseline and Week 8 or 9
Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo). Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mirvetuximab Soravtansine | 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 Participants |
| Investigator's Choice (IC) Chemotherapy | 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) | 23 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Up to approximately 37 months
Population: The Safety Population included all participants who received at least one dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mirvetuximab Soravtansine | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 211 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 194 Participants |
Secondary
Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1
ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
Time frame: Up to approximately 36 months
Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirvetuximab Soravtansine | Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1 | 41.9 percentage of participants |
| Investigator's Choice (IC) Chemotherapy | Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1 | 15.9 percentage of participants |
Secondary
Overall Survival Assessed by the Investigator Using RECIST v1.1
Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method.
Time frame: Up to approximately 45 months
Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mirvetuximab Soravtansine | Overall Survival Assessed by the Investigator Using RECIST v1.1 | 16.85 months |
| Investigator's Choice (IC) Chemotherapy | Overall Survival Assessed by the Investigator Using RECIST v1.1 | 13.34 months |
Secondary
Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.
Time frame: Baseline up to approximately 36 months
Population: The CA-125-Evaluable Population included all randomized participants who received at least 1 dose of MIRV or IC Chemo, whose pretreatment CA-125 was ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to randomization, and who had at least 1 post-baseline CA-125 evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirvetuximab Soravtansine | Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | 58.0 percentage of participants |
| Investigator's Choice (IC) Chemotherapy | Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | 30.1 percentage of participants |
Secondary
Time to Second Progression-Free Survival (PFS 2)
PFS 2 was defined as the time from date of randomization until second disease progression or death whichever occurred first.
Time frame: Up to approximately 44 months
Population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mirvetuximab Soravtansine | Time to Second Progression-Free Survival (PFS 2) | 11.01 months |
| Investigator's Choice (IC) Chemotherapy | Time to Second Progression-Free Survival (PFS 2) | 7.59 months |