Roche Holding AG will skip a mid-stage study of an experimental immunotherapy for breast cancer and proceed directly to a phase 3 trial later this year.
The Swiss company will study MPDL3280A for triple-negative breast cancer, which is currently treated mostly with chemotherapy, spokeswoman Holli Dickson said in a phone interview. The drug will be tested in combination with chemotherapy.
The company will present results from an early-stage study of the drug at a cancer meeting in Philadelphia on April 20. Roche is competing with Merck & Co. to develop a drug for a segment of the breast cancer market that may reach as much as $5 billion in peak sales, according to Goldman Sachs Group Inc. analysts.
In triple-negative breast cancer, tumor cells don’t have estrogen or progesterone receptors and don’t have extra HER2 proteins or surplus copies of the HER2 gene. About 15 percent of breast-cancer patients have that type.
Roche’s drug already has U.S. Food and Drug Administration “breakthrough” status for bladder and lung cancers, which can lead to faster review and approval.