Merck (MSD) is launching a Phase 3 KEYNOTE-811 clinical trial evaluating KEYTRUDA (pembrolizumab) plus trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2 (HER2)-positive locally advanced unresectable or metastatic gastric cancer. The final analysis results of the study were announced. Gastroesophageal junction (GEJ) adenocarcinoma.
The randomized, double-blind KEYNOTE-811 trial evaluated Keytruda plus chemotherapy containing trastuzumab, a fluoropyrimidine, and platinum as first-line treatment.
The study's two primary endpoints were progression-free survival (PFS) and overall survival (OS), with secondary endpoints consisting of objective response rate (ORR), duration of response, and safety.
The trial enrolled 698 subjects and compared Keytruda 200 mg given every three weeks in combination with chemotherapy containing trastuzumab, a fluoropyrimidine, and platinum to a placebo in combination with trastuzumab and chemotherapy.
The study met its dual primary endpoint of overall survival (OS) and demonstrated significant improvement in patients treated with the Keytruda regimen, according to the latest data.
The final analysis also confirmed that the Keytruda combination regimen led to statistically significant and clinically meaningful improvements in OS in the intention-to-treat (ITT) study population, particularly in those with PD-L1-expressing tumors.
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Keytruda's safety profile in this study was consistent with previous studies and no new safety signals were identified.
A previous interim analysis demonstrated that the KEYTRUDA regimen met the other primary endpoint of PFS.
Following initial results, the U.S. Food and Drug Administration (FDA) has recommended trastuzumab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric cancer or GEJ adenocarcinoma whose tumors express PD. granted early approval for Keytruda in combination with L1.
“We are thrilled to be partnering with Merck Research,” said Dr. Marjorie Greene, head of Global Clinical Development Oncology and senior vice president at Merck Research Laboratories. “Patients diagnosed with advanced gastric cancer often face a poor prognosis, highlighting the need for treatment options that have the potential to extend patients' lives.
“These overall survival results from KEYNOTE-811 are encouraging and build on the study's progression-free survival, overall response rate, and duration of response data.”
Last month, MSD announced positive data from the Phase III STRIDE-10 trial of its investigational pneumococcal conjugate vaccine V116.