Clinical Trial

A Multicenter, randomized, open label, Phase 3 Trial of Trastuzumab Deruxtecan (ENHERTU®) plus chemotherapy plus or minus Pembrolizumab versus chemotherapy plus Trastuzumab plus or minus Pembrolizumab as first line treatment in participants with unresectable, locally advanced or metastatic HER2-postive Gastric or GEJ cancer. (Destiny- Gastric05) (Trial of Trastuzumab Deruxtecan (ENHERTU®) plus chemotherapy plus or minus Pembrolizumab versus chemotherapy plus trastuzumab plus or minus Pembrolizumab in first line metastatic HER2-positive gastric or GEJ cancer) (DS8201-724)

MOA: Trastuzumab deruxtecan (TDXd) is a HER2- directed ADC

Key Eligibility Criteria:

• Previously untreated, unresectable, locally advanced or metastatic HER2-positive gastric or GEJ cancer
• Centrally determined tumor PD-L1 CPS
  • Main Cohort: PD-L1 CPS ≥1
  • Exploratory Cohort: PD-L1 CPS <1
• Must provide a tumor sample for tissue-based IHC staining
• At least 1 target measurable lesion on CT or MRI
• Subjects with prior exposure to HER2-targeted therapy are excluded
• Subjects with known DPD enzyme deficiency are excluded