ZURICH (Reuters) - Roche won U.S. approval on Friday of its immunotherapy Tecentriq to treat a significant number of patients with triple-negative breast cancer, a development hailed by doctors as a promising advance in fighting the aggressive disease.
The U.S. Food and Drug Administration (FDA) approved Tecentriq mixed with the chemotherapy Abraxane to treat inoperable, locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, a protein that may help cancers avoid detection by the immune system.
Roughly 40 percent of the patients in Roche’s study had tumors with high PD-L1 levels.
The FDA’s OK was based on a trial that showed the drug cocktail helped stave off the disease’s advance by a median 7.4 months, compared to 4.8 months with chemotherapy, Basel-based Roche said. The company, which is still awaiting overall survival data, said keeping the regulator’s blessing may depend on the results of further, confirmatory trials.
Roche’s Tecentriq has fallen well behind immunotherapies Keytruda from Merck and Opdivo from Bristol-Myers Squibb in treatment areas such as lung cancer. It hopes beating the two rival therapies in less common diseases like triple-negative breast cancer will help its medicine’s revenue accelerate.
“This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease,” Sandra Horning, Roche’s chief medical officer, said in a statement.
Tecentriq’s 2018 sales were 772 million Swiss francs ($766 million), compared with $7.2 billion for Keytruda and $6.7 billion for Opdivo.
More than 250,000 cases of invasive breast cancer are diagnosed annually in the United States, some 15 percent of which are triple-negative.
With triple-negative breast cancer, three common types of receptors that spur tumor growth — estrogen, progesterone, and the so-called HER2 gene — are not present, according to the National Breast Cancer Foundation.
That means drugs, including from Roche, that have proven effective at targeting the disease via these receptors fall short, leaving scientists, doctors and patients searching for new options to combine with chemotherapy.
The approach offered by Roche with its Tecentriq cocktail is an exciting development, said Dr. Amy Tiersten, a breast oncologist at the Dubin Breast Center, The Tisch Cancer Institute at Mount Sinai.
“This is a first,” Tiersten said in a statement. “I am thrilled to be able to offer this revolutionary therapy to our patients.”
Bristol-Myers and Merck have also been working including with partners on combating triple-negative breast cancer with their own immunotherapies.
Reporting by John Miller; Editing by Mark Potter and Sonya Hepinstall