Merck Serono/Takeda Matuzumab Development In Question After Phase II Study

Merck Serono is reconsidering development of its monoclonal antibody matuzumab for the treatment of metastatic colorectal cancer after a Phase II study failed to meet its efficacy endpoint, the company announced Aug. 29.

The biologic is currently in development with the Japanese drug maker Takeda. Discussions between the two partners on the future of matuzumab are currently ongoing, Merck said.

Nonetheless, matuzumab is currently in Phase II studies for non-small cell lung cancer and gastric cancer as well.

"Naturally, we need to wait for the results of these studies before making decision on the future development of matuzumab in those indications," the company told "The Pink Sheet" DAILY.

The Phase II study evaluated matuzumab in combination with irinotecan in patients with metastatic colorectal cancer who had already failed on multiple prior treatments, including irinotecan, the firm said. The primary endpoint in the trial was response rate, but Merck said it is not releasing further details on the study until data are presented at a medical meeting.

Matuzumab was developed in Merck's laboratories, according to the company. Merck already markets the anti-EGFR monoclonal antibody Erbitux (cetuximab) outside of the U.S. under a partnership with ImClone/Bristol-Myers Squibb for metastatic colorectal cancer.

-Jessica Merrill

This article is reprinted from "The Pink Sheet" DAILY – Aug. 30, 2007

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