Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Datopotamab Deruxtecan · 2 trials · 2 indications
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Dato-DXd + Pembrolizumab + Platinum Chemotherapy | EXPERIMENTAL | Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]). |
| Dato-DXd + Pembrolizumab | EXPERIMENTAL | Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab. |
| Pembrolizumab + Pemetrexed + Platinum Chemotherapy | ACTIVE_COMPARATOR | Participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m\^2 pemetrexed plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]). |
| Datopotamab deruxtecan (Dato-DXd) | EXPERIMENTAL | Dose Escalation and Dose Expansion: Datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in participants with advanced or metastatic NSCLC |
| Name | Type | Description |
|---|---|---|
| Datopotamab Deruxtecan | DRUG | Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. |
| Pembrolizumab | DRUG | Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. |
| Pemetrexed | DRUG | Pemetrexed will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. |
| Carboplatin | DRUG | Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
| Cisplatin | DRUG | Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
| KEYTRUDA® | DRUG | Intravenous infusion Q3W on Day 1 of each 21-day cycle (fixed pembrolizumab dose 200 mg Q3W) |
Key Inclusion Criteria: 1. Sign and date the Main ICF, prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. 2. Adults ≥18 at the time the M...
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Datopotamab Deruxtecan is an investigational antibody-drug conjugate being studied for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC). It is being evaluated in combination with pembrolizumab, with or without platinum chemotherapy, in patients with metastatic NSCLC. The drug is currently in Phase 3 clinical development.
Datopotamab Deruxtecan is a monoclonal antibody-based therapy, classified as a -mab (antibody). It is designed to target cancer cells in non-small cell lung cancer. The specific molecular target is not disclosed in the available information, but the drug is being studied in biomarker-selected patient populations.
Datopotamab Deruxtecan is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced or metastatic non-small cell lung cancer.
Datopotamab Deruxtecan is in Phase 3 clinical development for the treatment of metastatic non-small cell lung cancer. It is being studied in combination with pembrolizumab, with or without platinum chemotherapy, as a first-line treatment. The drug is investigational and has not yet been approved by regulatory authorities.
Datopotamab Deruxtecan is being evaluated in two clinical trials. NCT05555732 is a Phase 3 study in 1,170 patients with metastatic non-small cell lung cancer, testing the drug with pembrolizumab plus or minus platinum chemotherapy. NCT04526691 is a Phase 1 study in 145 patients with advanced or metastatic NSCLC, testing the drug in combination with pembrolizumab.
Yes, Datopotamab Deruxtecan is also known as Dato-DXd. Clinical trials such as TROPION-Lung02 and TROPION-Lung07 refer to the drug by this alternative name. Both names refer to the same investigational antibody-drug conjugate being developed for non-small cell lung cancer.