Clinical Trial Results:
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
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Summary
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EudraCT number |
2020-000179-19 |
Trial protocol |
IE DE BG BE IT |
Global end of trial date |
16 Nov 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Nov 2023
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First version publication date |
25 Nov 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
IMGN853-0417
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04296890 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
ImmunoGen, Inc.
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Sponsor organisation address |
830 Winter Street, Waltham, United States, MA 02451
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Public contact |
CMO, ImmunoGen, ImmunoGen, Inc., +1 781-895-0600, clinicaltrials@immunogen.com
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Scientific contact |
CMO, ImmunoGen, ImmunoGen, Inc., +1 781-895-0600, clinicaltrials@immunogen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Apr 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Nov 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the trial was to determine the efficacy of mirvetuximab soravtansine in participants with platinum-resistant ovarian cancer (PROC) and high folate receptor alpha (FRα) expression.
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Protection of trial subjects |
This clinical study was conducted by the sponsor, the investigator, delegated investigator staff and sub-investigator(s), in accordance with the protocol, ethical principles that have their origins in the Declaration of Helsinki, the International Council on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice (GCP), and all applicable local regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Jul 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Israel: 2
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Country: Number of subjects enrolled |
United States: 24
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Country: Number of subjects enrolled |
Australia: 11
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Country: Number of subjects enrolled |
Spain: 26
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Country: Number of subjects enrolled |
Belgium: 11
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Country: Number of subjects enrolled |
Germany: 3
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Country: Number of subjects enrolled |
Ireland: 6
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Country: Number of subjects enrolled |
Italy: 23
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Worldwide total number of subjects |
106
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EEA total number of subjects |
69
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
59
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From 65 to 84 years |
46
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85 years and over |
1
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||
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Pre-assignment
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Screening details |
Participants were enrolled at 39 sites in North America, Europe, and Asia Pacific. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Mirvetuximab Soravtansine | ||||||||||||||||||||
Arm description |
Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W). | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Mirvetuximab Soravtansine
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Investigational medicinal product code |
IMGN853
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Other name |
MIRV
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Mirvetuximab soravtansine was administered per dose and schedule specified in the arm description.
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Baseline characteristics reporting groups
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Reporting group title |
Mirvetuximab Soravtansine
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Reporting group description |
Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Mirvetuximab Soravtansine
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Reporting group description |
Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W). | ||
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End point title |
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [1] | ||||||||
End point description |
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 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD. The investigator (INV) Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1.
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End point type |
Primary
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End point timeframe |
Up to 30 months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis was not planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | ||||||||
End point description |
DOR was defined as the time from the date of the first response (CR or PR), until the date of progressive disease (PD) or death from any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was 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 demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was estimated using the Kaplan-Meier method. All participants that showed a CR or PR according to RECIST 1.1 were analyzed.
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End point type |
Secondary
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End point timeframe |
Up to 30 months
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With CA-125 Confirmed Clinical Response per Gynecologic Cancer Intergroup (GCIG) Criteria | ||||||||
End point description |
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. The CA-125-Evaluable population was defined as all participants who received at least 1 dose of study drug and whose pretreatment sample was ≥2.0 times the upper limit of normal (ULN), within 2 weeks prior to first dose of mirvetuximab soravtansine, and who had at least 1 postbaseline CA-125 evaluation.
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End point type |
Secondary
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End point timeframe |
Up to 30 months
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| No statistical analyses for this end point | |||||||||
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End point title |
Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 | ||||||||
End point description |
PFS was defined as the time from initiation of study drug until the date of PD or death whichever occurred first, estimated using the Kaplan-Meier method. 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 demonstrate an absolute increase of at least 5 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. INV Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1.
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End point type |
Secondary
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End point timeframe |
Up to 30 months
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| No statistical analyses for this end point | |||||||||
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End point title |
Overall Survival Assessed by the Investigator Using RECIST v1.1 | ||||||||
End point description |
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. INV Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1.
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End point type |
Secondary
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End point timeframe |
Up to 30 months
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) | ||||||
End point description |
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does 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 all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. The Safety population was defined as participants who received at least 1 dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to 30 months
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to 30 months
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Adverse event reporting additional description |
Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.0
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Reporting groups
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Reporting group title |
Mirvetuximab Soravtansine
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Reporting group description |
Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Dec 2019 |
The main elements of the protocol amendment include the following:
• Increase in the total number of enrolled/evaluable participants.
• Addition of exploratory objective to evaluate potential tumor-based biomarkers predictive of response to mirvetuximab soravtansine.
• Noted allowance for a participant's legally authorized representative to sign the informed consent form in the inclusion criteria, consistent with existing language in the rest of the protocol.
• Added recommendation that participants who have discontinued study drug for reasons other than progressive disease prior to Week 36 (from Cycle 1 Day 1), and who have not received another anticancer therapy, be scanned every 6 weeks up to Week 36. This update is consistent with the frequency of disease assessments for all participants on treatment.
• Revised the definition of efficacy evaluable population. |
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28 Aug 2020 |
The primary reasons for amending this protocol were to update the inclusion and exclusion criteria, add the risk benefit conclusion, and include language to accommodate the COVID pandemic.
The following key changes were made:
• Updates to participant inclusion and exclusion criteria
• Clarification of prescreening informed consent form (ICF)
• Addition of risk benefit conclusion of mirvetuximab soravtansine
• Post-treatment pregnancy test language added
• Mirvetuximab soravtansine discontinuation criteria further defined
• CYP3A4/MRD1 interaction language updated
• Contraception details clarified
• Radiographical imaging assessment timing and details updated
• Recording of AEs/SAEs and retention of data updated
• Study monitoring and training language updated to accommodate the existing COVID pandemic. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
