![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Merck Serono Reports Failure in Cancer Trial
Merck Serono Reports Failure in Cancer Trial
September 7, 2007
Merck Serono, a division of Merck KGaA, reported failure in a Phase II clinical trial of the humanized monoclonal antibody matuzumab in combination with irinotecan in patients with metastatic colorectal cancer.
The cancer patients enrolled in the trial had already failed on multiple prior treatments, including irinotecan, and the clinical trial did not meet its pre-defined endpoint of activity. Merck Serono said it is therefore reconsidering further development of matuzumab in metastatic colorectal cancer “at this stage,” although the company and partner Takeda are continuing to study the drug in other tumors, including nonsmall cell lung cancer.
In a separate development, Merck Serono said that the European Commission has granted marketing authorization for a new formulation of its relapsing multiple sclerosis drug Rebif (interferon beta-1a). The new formulation was developed “to increase treatment benefit by improving injection tolerability while targeting an improved immunogenicity profile,” the company said.
Upcoming Events
-
21Oct