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Association details:
| Biomarker: | HER-2 negative + PD-L1 expression |
|---|---|
| Cancer: | Gastric Adenocarcinoma |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS ≥1)
Published date:
10/13/2023
Excerpt:
Merck...announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1)...The recommendation is based on results from the Phase 3 KEYNOTE-859 trial in which KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in patients whose tumors expressed PD-L1 (CPS ≥1).
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: C1 - Off-label
(Approved for Gastroesophageal Junction Adenocarcinoma)
New
Title:
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for New First-Line Indications in Advanced HER2-Negative Gastric or GEJ Adenocarcinoma in Tumors Expressing PD-L1 (CPS ≥1) and Advanced Biliary Tract Cancer
Excerpt:
Merck...announced the European Commission (EC) has approved two new indications for KEYTRUDA, Merck’s anti-PD-1 therapy, in gastrointestinal cancers...KEYTRUDA in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1.
