Roche drug shrinks tumors in half of patients with lung cancer mutation

[May 14, 2015]  By Deena Beasley

(Reuters) - A drug being developed by Roche Holding AG was shown in pivotal trials to shrink tumors in patients with advanced lung cancer with a specific gene mutation who had stopped responding to crizotinib, another drug in the same class.

Currently, Pfizer Inc's crizotinib, or Xalkori, is approved for patients with advanced non-small cell lung cancer with a mutation of the ALK gene. The mutation is found in about 4 percent of NSCLC cases.

Roche's alectinib is an oral ALK inhibitor, which the company says is able to cross the blood-brain barrier - an important benefit for lung cancer, which often spreads to the brain.

The company said that in one trial, 50 percent of patients responded to the drug, while the response rate was 47.8 percent in the second trial.
 

In addition, alectinib was shown to shrink tumors in people whose cancer had spread to the central nervous system. People whose tumors shrank in response to alectinib continued to respond for a median of 11.2 and 7.5 months, respectively, in the two studies.

Results from both studies were released on Wednesday ahead of the annual meeting of the American Society of Clinical Oncology later this month.

The most common side effects of alectinib were an increase in muscle enzymes, increased liver enzymes and shortness of breath.

Sandra Horning, chief medical officer at Roche's Genentech unit, said Roche plans to submit the trial results to the U.S. Food and Drug Administration this year. The company is also conducting a head-to-head study of alectinib compared with crizotinib.

(Reporting by Deena Beasley in Los Angeles; Editing by Matthew Lewis)

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