KEYTRUDA Meets Primary Trial Endpoint as Monotherapy and in Combination with Chemotherapy

Merck has announced topline findings from the final analysis of the pivotal Phase 3 KEYNOTE-062 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy and in combination with chemotherapy (cisplatin and either 5-fluorouracil or capecitabine) for the first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. In the monotherapy arm of the study, KEYTRUDA met a primary endpoint by demonstrating noninferiority to chemotherapy, the current standard of care, for overall survival (OS) in the entire intention-to-treat (ITT) population of patients whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥1). In the combination arm of KEYNOTE-062, KEYTRUDA plus chemotherapy was not found to be superior for OS (CPS ≥1 or CPS ≥10) or progression-free survival (PFS) (CPS ≥1) compared with chemotherapy alone. The safety profile of KEYTRUDA was consistent with that previously observed in gastric cancer. Results will be presented during an oral session at the 55^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago on June 2, 2019 and will be discussed with regulatory authorities.

"Gastric cancer is historically difficult to treat, and unfortunately continues to be associated with high mortality rates in many countries, particularly in the metastatic stage," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "KEYTRUDA monotherapy did show noninferior overall survival in the total patient population, though the study did not meet all of its primary endpoints. We sincerely thank the patients and investigators for their involvement in KEYNOTE-062 and look forward to sharing detailed study results with the medical community."

In September 2017, the U.S. Food and Drug Administration (FDA) approved KEYTRUDA as a third-line treatment for previously treated patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. KEYNOTE-062 is a potential confirmatory trial for this accelerated, third-line approval. In addition to KEYNOTE-062, additional first-line, Phase 3 studies in Merck’s gastric clinical program include KEYNOTE-811 and KEYNOTE-859, as well as KEYNOTE-585 in the neoadjuvant and adjuvant treatment setting.

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