Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mirvetuximab soravtansine plus Bevacizumab · 4 trials · 5 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
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.
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 |
| 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. |
| Mirvetuximab Soravtansine | EXPERIMENTAL | Participants will receive MIRV 6.0 mg/kg adjusted by ideal body weight (AIBW) |
| 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. |
| 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 | Intravenous (IV) infusion |
| Carboplatin | DRUG | IV Infusion |
| 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. |
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) ...
Top 20 of 61 competitors