![]() ![]() In May 2021, KEYTRUDA was approved in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in the U.S. In addition, these results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide. Food and Drug Administration (FDA) and is working with the FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma to those patients whose tumors are PD-L1 positive. Merck has discussed these findings with the U.S. ![]() In the study, more than 80% of patients had tumors that were PD-L1 positive. At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with trastuzumab and chemotherapy demonstrated a statistically significant improvement in PFS compared to placebo in combination with trastuzumab and chemotherapy in the intention-to-treat (ITT) study population.īased on a pre-specified subgroup analysis by PD-L1 expression, the improvement in PFS observed in the ITT population was limited to patients whose tumors were PD-L1 positive (Combined Positive Score ≥1). Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-811 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab and chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma ![]()
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