On June 20, 2023 erck (NYSE: MRK), known as MSD outside of the United States and Canada, reported topline results from the Phase 3 KEYNOTE-585 trial, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, followed by adjuvant treatment with KEYTRUDA plus chemotherapy, then KEYTRUDA monotherapy in patients with locally advanced resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma (Press release, Merck & Co, JUN 20, 2023, View Source [SID1234632797]). At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, the study met one of its primary endpoints of pathological complete response (pCR) rate and demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone. For the primary endpoint of event-free survival (EFS), there was an improvement in the KEYTRUDA arm; however, results did not meet statistical significance per the pre-specified statistical analysis plan. The endpoint of overall survival (OS) was not formally tested since superiority was not reached for EFS. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting.
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"While a statistically significant improvement in pathological complete response was observed in this study, we are disappointed that the KEYTRUDA regimen did not significantly improve event-free survival, a result that underscores the challenges in treating locally advanced resectable gastric cancer," said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. "Innovative research in earlier stages of cancer is critical to help patients achieve better outcomes, and our efforts continue in earnest. We are grateful to the patients and investigators for their participation in this study."
Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal, pancreatic and colorectal cancers.
About KEYNOTE-585
KEYNOTE-585 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03221426) evaluating KEYTRUDA in combination with chemotherapy (cisplatin plus capecitabine or cisplatin plus 5-fluorouracil) as neoadjuvant treatment, followed by adjuvant treatment with KEYTRUDA plus chemotherapy, then KEYTRUDA monotherapy for the treatment of patients with locally advanced resectable gastric and GEJ adenocarcinoma. The primary endpoints included EFS, defined as the time from randomization to the first occurrence of either radiographic disease progression, a local/distant recurrence, clinical progression or death from any cause; pCR rate, defined as a lack of all signs of cancer in tissue samples; and OS, defined as the time from randomization to death from any cause. Secondary endpoints included disease-free survival and safety. The trial enrolled 1,007 patients who were randomized 1:1 to receive three cycles of KEYTRUDA (200 mg every three weeks) in combination with chemotherapy as neoadjuvant treatment, followed by adjuvant treatment with three cycles of KEYTRUDA (200 mg every three weeks) plus chemotherapy, then KEYTRUDA monotherapy (200 mg every three weeks for up to 11 cycles) or neoadjuvant placebo plus chemotherapy, followed by adjuvant placebo plus chemotherapy, then placebo alone.
About gastric cancer
Gastric cancer – also called stomach cancer – is a type of cancer that begins in the stomach and tends to develop slowly over many years. Approximately 90-95% of gastric cancers are adenocarcinomas, which develop from cells in the innermost lining of the stomach (known as the mucosa). Gastric cancer is the fifth most diagnosed cancer and the fourth leading cause of cancer death worldwide, with approximately 1.1 million patients diagnosed and 768,000 patient deaths from the disease globally in 2020. In the U.S., it is estimated there will be approximately 26,500 patients diagnosed with gastric cancer and 11,000 patient deaths from the disease in 2023.