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Also known as mirvetuximab soravtansine (MIRV; IMGN853)
Mirvetuximab Soravtansine · 5 trials · 10 indications
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).
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
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This endpoint will be assessed in the participants receiving MIRV who are asymptomatic .
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
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| Name | Type | Description |
|---|---|---|
| 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 |
| Bevacizumab | DRUG | Intravenous (IV) infusion (per investigator's discretion) |
| 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. |
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 h...
Mirvetuximab Soravtansine is an investigational antibody-drug conjugate being studied for the treatment of ovarian cancers, including epithelial ovarian cancer, recurrent ovarian cancer, high-grade ovarian cancer, and advanced high-grade epithelial ovarian cancer. It is being evaluated in patients whose tumors express high levels of folate receptor-alpha (FRα).
Mirvetuximab Soravtansine is a -mab (antibody) type of therapy. It is designed to target cancer cells that express folate receptor-alpha (FRα), a protein commonly found on ovarian cancer cells. By binding to this receptor, the drug delivers a cytotoxic agent directly to the tumor cells.
Mirvetuximab Soravtansine is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ovarian cancer.
Mirvetuximab Soravtansine is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trials are evaluating the drug in patients with recurrent ovarian cancer and platinum-resistant advanced high-grade epithelial ovarian cancer.
Mirvetuximab Soravtansine is being studied in several clinical trials, including NCT05456685, a Phase 2 trial combining the drug with carboplatin in platinum-sensitive epithelial ovarian cancer; NCT06365853, a Phase 2 trial evaluating ocular toxicity in recurrent ovarian cancer; and NCT06682988, a Phase 2 trial in platinum-resistant advanced high-grade epithelial ovarian cancer. A Phase 3 trial, NCT04209855, has been completed.
Mirvetuximab Soravtansine is also known as mirvetuximab soravtansine (MIRV; IMGN853). The name 'Mirvetuximab soravtansine plus Bevacizumab' refers to a combination regimen that includes Mirvetuximab Soravtansine together with the anti-angiogenic agent Bevacizumab, rather than the drug alone.