News briefs from Merck KGaA and Sanofi

German drug major Merck KGaA )MRK: DE) revealed this morning that its Phase III EXPAND trial, which assessed Erbitux (cetuximab) in combination with cisplatin and capecitabine as a first-line treatment for patients with advanced gastric adenocarcinoma (AGA) including adenocarcinoma of the gastro-esophageal junction (GEJ), 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 Florian Lordick, professor at Klinikum Braunschweig, Hannover Medical School, Germany.

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.