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Label indication ELAHERE ® is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test [see Dosage and Administration ( 2.1 )]. FDA label
Also known as mirvetuximab soravtansine, MIRV, ELAHERE™, Mirvetuximab Soravtansine-gynx
IMGN853 · 11 trials · 14 indications
Progression-free survival defined as assessed by BICR per RECIST v1.1, defined as the time from date of randomization until BICR-assessed PD or death due to any cause, whichever occurs first
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.
OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS).
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
OR is defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
PFS is defined as the time from the date of randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause, whichever occurs first.
An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.
ORR is defined as best response of confirmed complete response (CR) or partial response (PR), as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Cmax of MIRV
AUC of MIRV
Ctrough of MIRV
Vss) of MIRV
Tmax of MIRV
t1/2 of MIRV
This endpoint will be assessed in the participants receiving MIRV who are asymptomatic .
PFS will be defined as the time from first dose of MIRV and Olaparib until investigator-assessed radiologic PD or death, whichever occurs first
ORR following carboplatin plus MIRV combination as measured by the investigator and assessed according to RECIST v1.1, defined as the proportion of confirmed responders (CR or PR) among participants with FRα expression of ≥ 50% o ORR following carboplatin plus MIRV combination will also be measured, as a sensitivity analysis, by a blinded independent central review (BICR) in the same participant population
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.
To assess percentage of patients with advanced-stage ovarian, fallopian tube, and peritoneal cancers per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 and Gynecological Cancer Intergroup Cancer antigen 125 (GCIG CA-125) criteria.
To assess ORR per iRECIST 1.1 and GCIG CA-125 criteria
Radiographic tumor response by CT or MRI of chest, abdomen, and pelvis using RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Mirvetuximab Soravtansine (MIRV) plus Bevacizumab |
| Arm 2 | ACTIVE_COMPARATOR | Bevacizumab monotherapy |
| Mirvetuximab Soravtansine | EXPERIMENTAL | Participants will receive 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). |
| Investigator's Choice (IC) Chemotherapy | ACTIVE_COMPARATOR | Participants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (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 be 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 be administered as a 1-hour infusion. |
| Carboplatin + Mirvetuximab Soravtansine | EXPERIMENTAL | Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion. |
| Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A | EXPERIMENTAL | Participants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration. |
| Substudy 1 Arm B: MIRV Dose B | EXPERIMENTAL | Participants will receive dose B of MIRV with Bev, as part of the approximately 40 month study duration. |
| Substudy 1 Arm C: Bev | EXPERIMENTAL | Participants will receive Bev, as part of the approximately 40 month study duration. |
| Substudy 2 Arm D: MIRV Dose A | EXPERIMENTAL | Participants will receive dose A of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration. |
| Substudy 2 Arm E: MIRV Dose B | EXPERIMENTAL | Participants will receive dose B of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration. |
| Substudy 3 Arm F: MIRV Dose A | EXPERIMENTAL | Participants will receive dose A of MIRV with BEV and carboplatin, followed by MIRV at a lower dose with BEV, as part of the approximately 31 month study duration. |
| Substudy 3 Arm G: MIRV Dose B | EXPERIMENTAL | Participants will receive dose B of MIRV with BEV and carboplatin, followed by MIRV at the same dose with BEV, as part of the approximately 31 month study duration. |
| Randomized Phase 2 Cohort: Arm A | EXPERIMENTAL | Participants will receive Mirvetuximab Soravtansine at the standard dose on Day 1 of a 21-day cycle. |
| Randomized Phase 2 Cohort: Arm B | EXPERIMENTAL | Participants will receive Mirvetuximab Soravtansine at a lower dose than the standard dose on Day 1 and Day 15 of a 28-day cycle . |
| Hepatic Impairment Cohort : Mirvetuximab Soravtansine | EXPERIMENTAL | Participants will receive Mirvetuximab Soravtansine on Day 1 of a 21-day cycle. Different doses will be given to groups of patients to identify a safe and effective dose. |
| Primary Prophylactic Steroid Eye Drops | EXPERIMENTAL | Prednisolone acetate ophthalmic suspension 1% 6 times daily on Days -1 to 4 and 4 times daily (QID) on Days 5 to 8 of each cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow steroid dosing, when given, by approximately 15 minutes); MIRV 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) every 3 weeks (Q3W) on Day 1 of each cycle. Each cycle length = 21 days. |
| Primary Prophylactic Vasoconstricting Eye Drops | EXPERIMENTAL | Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) on Days 1 to 8 of each cycle (vasoconstricting drops should be started on the day of first infusion and should begin before the first infusion on Cycle 1 Day 1); Lubricating eye drops QID throughout the entire cycle (doses should follow brimonidine dosing, when given, by approximately 15 minutes); MIRV 6 mg/kg AIBW Q3W on Day 1 of each cycle. Each cycle length = 21 days. |
| Safety Lead In | EXPERIMENTAL | - |
| Treatment | EXPERIMENTAL | All patients will receive MIRV at 5mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle (Q3W). All patients will receive Olaparib at 300mg taken orally twice daily with or without food. Dosage and administration will follow current single-agent Olaparib package insert dosage and administration guidelines. Patients will continue to receive MIRV and Olaparib until PD, unacceptable toxicity, withdrawal of consent, or death, whichever comes first. If toxicity deems the patient to discontinue one drug, the patient may continue the other drug until PD, unacceptable toxicity, withdrawal of consent, or death, whichever comes first. |
| MIRV + Carboplatin | EXPERIMENTAL | On Day 1 of every 3-week cycle (Q3W) for 6 cycles, MIRV will be given at the dosage of 6 mg/kg of AIBW along with carboplatin given at area under the AUC5 administered through intravenous (IV) infusion (maximum dosing per National Comprehensive Cancer Network \[NCCN\] guidelines \[NCCN 2021\]). Upon completion of carboplatin plus MIRV treatment, single-agent MIRV will be continued at the tolerated dose on Day 1 Q3W in participants with investigator determined stable disease (SD), complete response (CR) or partial response (PR). |
| Arm A: alpha receptor positive_neoadjuvant chemotherapy regimen | EXPERIMENTAL | * IV Carboplatin AUC 5 (Q21 days) 7 cycles (first cycle is Carbo alone, dosing for C1D1 will be provider's choice) * IV Mirvetuximab 6 mg/kg (adjusted ideal body weight) day 1 (Q21 days) 6 cycles (starting with cycle #2) |
| Arm B: alpha receptor negative | NO_INTERVENTION | If a patient is found to be negative for FRα expression, they will be ineligible to receive the study treatment under the main study (Arm A). FRα negative patients will be enrolled under the biomarker-only arm (Arm B), and their treating physician can select the treatment they deem appropriate. |
| IMGN853 | EXPERIMENTAL | IMGN853 administered 6 mg/kg adjusted ideal body weight (AIBW) once every three weeks (Q3W) |
| Name | Type | Description |
|---|---|---|
| Mirvetuximab soravtansine plus Bevacizumab | DRUG | Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks |
| Bevacizumab | DRUG | Participants will receive Bevacizumab 15mg/kg every 3 weeks |
| Mirvetuximab Soravtansine | DRUG | Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm. |
| Paclitaxel | DRUG | Paclitaxel will be administered per dose and schedule specified in the arm. |
| Topotecan | DRUG | Topotecan will be administered per dose and schedule specified in the arm. |
| Pegylated liposomal doxorubicin | DRUG | Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm. |
| Carboplatin | DRUG | Intravenous (IV) infusion |
| Lubricating Eye Drops | DRUG | Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration. |
| Prednisolone acetate ophthalmic suspension 1% eye drops | DRUG | Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician. |
| Brimonidine tartrate ophthalmic solution eye drops | DRUG | Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician. |
| Mirvetuximab Soravtansine-gynx | DRUG | is an antibody-drug conjugate (ADC) that consists of a high affinity humanized monoclonal antibody against folate receptor α (FRα, the protein product of the folate receptor 1 \[FOLR1\] gene) that is conjugated to a cytotoxic maytansinoid by the hindered disulfide succinimidyl 4-(pyridine-2-yl)disulfanyl)-2-sulfo-butyrate linker (sulfo-SPDB). |
| Olaparib | DRUG | Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular functions, such as DNA transcription and DNA repair. |
| mirvetuximab soravtansine (MIRV; IMGN853) | DRUG | Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC) that consists of a high affinity humanized monoclonal antibody against folate receptor α (FRα, the protein product of the folate receptor 1 \[FOLR1\] gene) that is conjugated to a cytotoxic maytansinoid by the hindered disulfide succinimidyl 4-(pyridin-2-yl)disulfanyl)-2-sulfo-butyrate linker (sulfo-SPDB) linker. FRα is a glycosyl-phosphatidylinositol (GPI)-linked protein, which shows limited normal tissue expression and high expression on the surface of solid tumors, particularly epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (referenced herein collectively as EOC), endometrial cancer, non-small cell lung cancer (NSCLC), and renal cell cancer. |
| IMGN853 | DRUG | IMGN853 6 mg/kg intravenously every 3 weeks until disease progression |
Inclusion Criteria: 1. Adult women \>/=18 years old 2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer 3. Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1) 4. Relapsed disease after frontline (first-line) ...
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IMGN853 is being studied as a treatment for folate receptor-alpha positive endometrial cancer. It is an investigational antibody-drug conjugate in Phase 2 development for this indication. The ongoing trial enrolls women 18 years and older with FRα positive endometrial cancer in the United States.
IMGN853 targets folate receptor-alpha, a protein expressed on certain cancer cells. It is an antibody-drug conjugate designed to bind FRα and deliver a cytotoxic payload to target cells. The Phase 2 trial specifically enrolls patients whose tumors are FRα positive, making it a biomarker-selected study.
IMGN853 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the ongoing Phase 2 study evaluating the drug in endometrial cancer.
IMGN853 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The current Phase 2 trial is actively recruiting participants with folate receptor-alpha positive endometrial cancer.
IMGN853 is being evaluated in the Phase 2 trial NCT03832361, titled Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer. The trial is recruiting, is uncontrolled, and plans to enroll 50 female participants aged 18 years and older in the United States.
Yes, IMGN853 is also known as mirvetuximab soravtansine. The Phase 2 trial in endometrial cancer lists both names in its title, confirming they refer to the same antibody-drug conjugate targeting folate receptor-alpha.