Merck announced the outcome of the Phase 3 clinical trial EXPAND, which assessed Erbitux (cetuximab) in combination with cisplatin and capecitabine as a first-line treatment for patients with advanced gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction (GEJ). The trial did not meet its primary endpoint of extending the length of time that patients live without their disease getting worse (progression-free survival - PFS), as determined by independent review.
“We are disappointed that the EXPAND trial did not show a benefit for patients with advanced gastric cancer when Erbitux was added to standard chemotherapy. Patients with advanced gastric cancer currently have few treatment choices and a poor prognosis, and we will continue to investigate other treatment options for these patients in the hope of being able to offer improved outcomes,” said lead investigator Professor Florian Lordick, MD, Klinikum Braunschweig, Hannover Medical School, Germany.
EXPAND was a multi-center, open-label, randomized, controlled trial in 904 patients at 150 centers in 25 countries across Latin America, Europe, Asia Pacific and Japan. Patients had unresectable advanced cancer of the stomach or GEJ and had received no prior treatment with chemotherapy or radiotherapy in this setting. Usually, these patients would receive palliative chemotherapy only.
The study’s primary endpoint was PFS as determined by an independent review committee (IRC). Secondary endpoints were overall survival (OS), best overall response rate determined by IRC, safety and quality of life.
“Understandably, these results are disappointing for patients with advanced gastric cancer, and as a company we will continue to invest in oncology research and development to find new treatments for these diseases with high unmet medical need,” said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for the Merck Serono division.
Erbitux in combination with cisplatin and capecitabine did not show any new or unexpected safety findings.
These results do not alter the proven utility of Erbitux in its already approved indications in metastatic colorectal cancer and head and neck cancer.
More detailed results from the trial will be submitted for presentation at upcoming international scientific meetings.
Date: July 5, 2012
Source: Merck KGaA