Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
R-DXd · 4 trials · 6 indications
PFS is defined as the time from randomization to the first documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered disease progression. PFS as assessed by blinded independent central review (BICR) will be presented.
OS is defined as the time from randomization to death due to any cause.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be assessed by Blinded Independent Central Review (BICR). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
The ORR was defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR), by BICR assessment based on RECIST version 1.1.
PFS is defined as the time from the date of randomization to the date of disease progression, defined as the first documented radiological progression or death due to any cause, whichever comes first.
| Arm | Type | Description |
|---|---|---|
| R-DXd +/- Bevacizumab | EXPERIMENTAL | Participants will receive intravenous (IV) raludotatug deruxtecan (R-DXd) with or without IV bevacizumab for up to 2 years until progressive disease (PD), unacceptable toxicity, or other protocol-specified reason for discontinuation |
| Standard of Care | ACTIVE_COMPARATOR | Participants receive 6 to 8 cycles of investigator's choice of one of three options of platinum-based chemotherapy with or without IV bevacizumab. Bevacizumab treatment if elected, will continue until PD, unacceptable toxicity, or other protocol specified reason for discontinuation |
| Arm 1: R-DXd with or without bevacizumab | EXPERIMENTAL | Participants will receive intravenous (IV) raludotatug deruxtecan (R-DXd)with or without IV bevacizumab for up to 2 years until progressive disease (PD), unacceptable toxicity, or other protocol-specified reason for discontinuation. |
| Arm 2: Standard of care (bevacizumab or observation only) | ACTIVE_COMPARATOR | Participants will receive bevacizumab 15 mg/kg IV q3w for up to 22 cycles (each cycle=21 days) until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention or will be observed and actively followed if not receiving bevacizumab. |
| Arm 1: Raludotatug deruxtecan (R-DXD) | EXPERIMENTAL | Participants receive 5.6 mg/kg of R-DXD, every 3 weeks (Q3W) (Day 1 of every 21-day cycle) via intravenous (IV) infusion until progressive disease (PD) or discontinuation. |
| Arm 2: Infinatamab deruxtecan (I-DXD) High Dose | EXPERIMENTAL | Participants receive 12 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation. |
| Arm 3: I-DXD Low Dose | EXPERIMENTAL | Participants receive 8 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation. |
| Arm 4: Docetaxel | ACTIVE_COMPARATOR | Participants receive 75 mg/m\^2 of Docetaxel, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation. |
| Part A: R-DXd 4.8mg/kg Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous R-DXd administered at a dose of 4.8 mg/kg every 3 weeks (Q3W). |
| Part A: R-DXd 5.6 mg/kg Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous R-DXd administered at a dose of 5.6 mg/kg every 3 weeks (Q3W). |
| Part A: R-DXd 6.4 mg/kg Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous R-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W). |
| Part B: R-DXd RP3D Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous R-DXd administered at the Recommended Phase 3 Dose (RP3D) every 3 weeks (Q3W). |
| Part B: Investigator's Choice | ACTIVE_COMPARATOR | Participants will be randomized to receive intravenous treatment with investigator's choice of paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan. |
| Name | Type | Description |
|---|---|---|
| R-DXd | BIOLOGICAL | R-DXd alone or in combination with bevacizumab administered via IV infusion |
| Bevacizumab | DRUG | Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w |
| Carboplatin | DRUG | Carboplatin area under the curve (AUC) 5 mg/mL\*min or AUC 4 mg/mL\*min administered on day 1 q3w for a maximum of 8 cycles |
| Paclitaxel | DRUG | Paclitaxel 175 mg/m\^2 administered via IV infusion on day 1 q3w for a maximum of 8 cycles |
| Gemcitabine | DRUG | Gemcitabine 1000 mg/mL administered via IV infusion on day 1 and day 8 of each 3-week cycle for a maximum of 8 cycles |
| Pegylated liposomal doxorubicin (PLD) | DRUG | PLD 30 mg/m\^2 administered via IV infusion on day 1 of each 4-week cycles for a maximum of 8 cycles |
| I-DXD | BIOLOGICAL | IV Infusion |
| Docetaxel | DRUG | IV Infusion |
| Rescue Medications | DRUG | Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines. |
| Rescue Medication | DRUG | Participants are premedicated with corticosteroids per approved product label and following institutional standards or local guidelines. |
| Topotecan | DRUG | Topotecan will be administered as an IV infusion |
| PLD | DRUG | PLD will be administered as an IV infusion |
The main inclusion criteria include but are not limited to the following: * Has a histologically or cytologically documented advanced high-grade serous or high-grade endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer. * Has received 1 line of platinum-based therapy with a...
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R-DXd, also known as raludotatug deruxtecan, is an investigational monoclonal antibody being studied for the treatment of solid cancers, including ovarian cancer, primary peritoneal cancer, fallopian tube cancer, and non-small cell lung cancer. It is currently in Phase 2 clinical development for these indications.
R-DXd is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being evaluated in clinical trials for its potential efficacy in treating certain solid tumors, including ovarian and lung cancers.
R-DXd is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with various solid tumors.
R-DXd is currently in Phase 2 clinical development. It is being studied in two active Phase 2 trials, one for platinum-resistant ovarian cancer and another for previously treated stage IV squamous non-small cell lung cancer. The drug is investigational and has not yet been approved by regulatory authorities.
R-DXd is being evaluated in two active Phase 2 clinical trials: NCT06161025, which is studying the drug in patients with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer, and NCT06780098, which is investigating it in patients with previously treated stage IV squamous non-small cell lung cancer.
Yes, R-DXd is the same as raludotatug deruxtecan. The drug is referred to by both names in clinical trial documentation, with R-DXd being the abbreviated form used in study titles and descriptions.