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Mirvetuximab Soravtansine-gynx · 1 trial · 3 indications
PFS will be defined as the time from first dose of MIRV and Olaparib until investigator-assessed radiologic PD or death, whichever occurs first
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Provision to sign and date the consent form * Stated willingness to comply with all study procedures and be available for the duration of the study * Be a woman aged ≥18 years of age * Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 o...
Mirvetuximab Soravtansine-gynx is an investigational antibody-drug conjugate being studied for the maintenance treatment of ovary cancer, as well as peritoneal cancer and fallopian tube cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Mirvetuximab Soravtansine-gynx is a monoclonal antibody (mab) that targets folate receptor alpha, a protein commonly expressed on ovarian cancer cells. By binding to this receptor, the drug delivers a cytotoxic agent directly to cancer cells, potentially reducing damage to healthy tissues.
Mirvetuximab Soravtansine-gynx 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-gynx is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is recruiting participants to further assess its potential as a maintenance therapy.
Mirvetuximab Soravtansine-gynx is being evaluated in a Phase 2 clinical trial registered as NCT05887609. This trial, titled 'An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib,' is recruiting 53 female patients aged 18 years and older with ovary, peritoneal, or fallopian tube cancer in the United States.