The decision is a serious blow to the company’s efforts to beef up its business operations in oncology treatments.
The world’s largest biotech drug maker Amgen and Japan’s Takeda Pharmaceutical Co. have been involved in testing the drug as an initial treatment for non-small cell lung cancerdefine (NSCLC), said the officials of the companies. The companies were forced into taking the decision of suspending the trial considering the data of nearly 600 patients which revealed a higher mortality rate among the group receiving the drug compared to the placebo group, revealed the reports.
The official spokesperson for Amgen, Christine Regan, told that the drug is one of the two Amgen treatments in the third and final stage of human tests mandatory for U.S. regulatory approval.
Amgen's executive vice president of research and development, Roger M. Perlmutter, M.D., Ph.D., shared his disappointed with the results of the drug motesanib which blocks VEGF, a protein involved in growth of blood vessels that promote tumors. “While we are disappointed in this outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents,” he said.
“Patient safety is our top priority, hence we have acted quickly to implement the recommendations of the DMC. Working with our development partner, Takeda, we will continue to evaluate the therapeutic potential of motesanib in non-squamous NSCLC and metastatic breast cancer, as well as in other solid tumors,” maintained Perlmutter.
The committee involved in monitoring the data of the trial recommended the patients with squamous non-small-cell lung cancer (NSCLC) on motesanib to stop the drug with immediate effect as they had higher incidence of hemoptysis. The committee, however, maintained that those taking the drug for non-squamous version of the disease could continue with the treatment.
According to the National Cancer Institute, lung cancer kills nearly 161,000 U.S. residents every year and about 215,000 new cases are diagnosed with the disease each year.
“NSCLC continues to be an area where new and effective therapies are needed. We look forward to the follow up recommendations from the DMC in order to chart the best path forward for the development of this molecule," revealed Nancy Simonian, M.D., chief medical officer, Millennium: The Takeda Oncology Company.
The company officials revealed that a safety committee is likely to review new data from the study within a period of three months.
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