Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sacituzumab Govitecan · 1 trial · 1 indication
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as per the Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD 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 PD. RECIST 1.1 is modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. 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.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab + Sacituzumab Govitecan | EXPERIMENTAL | Participants receive sacituzumab govitecan 10mg/kg intravenous (IV) infusion once weekly on Day 1 and Day 8 of a continuous 21-day cycle until progressive disease (PD) requiring discontinuation, unacceptable toxicity, withdrawal of consent, or death. Participants receive pembrolizumab 200mg IV infusion on Day 1 every 3 weeks (Q3W) for up to 35 cycles (each cycle length = 21 days). |
| Pembrolizumab | EXPERIMENTAL | Participants receive pembrolizumab 200mg IV infusion on Day 1 Q3W for up to 35 cycles (each cycle length = 21 days). |
| Name | Type | Description |
|---|---|---|
| Sacituzumab Govitecan | BIOLOGICAL | IV infusion |
| Pembrolizumab | BIOLOGICAL | IV infusion |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC) * Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (...
Sacituzumab Govitecan is being studied for the treatment of metastatic non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) of 50% or higher. It is currently in Phase 3 clinical development for this indication, administered in combination with pembrolizumab.
Sacituzumab Govitecan is a monoclonal antibody, classified as an antibody drug. In the ongoing clinical trial, it is being evaluated in combination with pembrolizumab for patients with metastatic non-small cell lung cancer that has high PD-L1 expression.
Sacituzumab Govitecan is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting a Phase 3 clinical trial of the drug for non-small cell lung cancer.
Sacituzumab Govitecan is in Phase 3 clinical development. It is being studied as an investigational therapy for metastatic non-small cell lung cancer with high PD-L1 expression, and it has not yet been approved for this indication.
Sacituzumab Govitecan is being evaluated in the Phase 3 clinical trial NCT05609968. This study compares pembrolizumab monotherapy versus sacituzumab govitecan in combination with pembrolizumab in participants with metastatic non-small cell lung cancer and a PD-L1 TPS of 50% or higher.
No, Sacituzumab Govitecan is not the same as pembrolizumab. In the Phase 3 trial NCT05609968, sacituzumab govitecan is being tested in combination with pembrolizumab, and the study compares this combination against pembrolizumab alone in patients with metastatic non-small cell lung cancer.