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Amgen Halts Phase III Trials Of Lung Cancer Drug

Posted by Chrissie Cole
Friday, November 21, 2008 12:12 AM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Lung Cancer, Amgen, Motesanib, Takeda



Biotech drugmaker Amgen Inc. and Japan’s Takeda Pharmaceutical Co., have suspended enrollment in the last-stage trial of a key cancer drug, after patients on the drug died more often than those taking placebo.

Amgen and Takeda, Japan’s largest pharmaceutical maker, are reviewing data and have yet to decide if they will resume trials or halt development of the drug, montesanib, said a spokeswoman for Takeda on Thursday.

Motesanib is part of a broad co-development program between Amgen and Takeda.

The drug was being tested as a first-line treatment in combination with chemotherapy for non-small cell lung cancer.

The trial was suspended following a planned safety data review of 600 patients that found higher early mortality rates among those getting montesanib, compared to patients that were given placebo, said both companies in a joint statement.

Phase III trials are expanded controlled/uncontrolled trials after preliminary indication has shown effectiveness of the drug has been reached and are intended to compile additional information to evaluate the overall benefit-risk and provide adequate basis for labeling.

Amgen has pushed to develop oncology treatments over the past several years and currently has eight cancer medications in late-stage clinical trials, which are needed to gain U.S. regulatory approval, with more in early-stage studies.

Motesanib is an experimental cancer drug. It works by starving tumor cells of the blood supply which they need to grow. The drug blocks a protein known as VEGFR, which plays a role in the growth of blood vessels that feed tumors.

The halted trial was one of three studies that Amgen is expecting clinical data in 2009-10, said Robert Bradway.

According to the company, the suspension applies to patients with squamous non-small cell cancer only. A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope.

The leading cause of cancer death is Lung cancer. The disease claims the lives of more than 157,000 American men and women annually. More people died each year from lung cancer than that of breast, prostate and colon cancers combined. #

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