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The findings could lead to the first U.S. Food and Drug Administration approval of an immunotherapy drug to treat breast cancer and may change the standard of care for women with advanced triple-negative breast cancer, according to The New York Times.
Triple-negative tumors occur in only about 15 percent of patients with invasive breast cancer in the United States (nearly 40,000 each year), but account for as many as 30 to 40 percent of breast cancer deaths.
The study included 902 patients treated at 246 medical centers in 41 countries. Half received chemotherapy alone (nab-paclitaxel/Abraxane), and half received chemotherapy plus Genentech's immunotherapy drug atezolizumab (Tecentriq), The Times reported.
Median survival was 17.6 months among those who received chemotherapy alone and 21.3 months among those who received the combination therapy. That difference was not statistically significant.
But among women with a marker called PD-L1 on their cancer cells, median survival was 15.5 months among those who received chemotherapy alone and 25 months in the combination group.
Those results have not been analyzed statistically, and the patients are still being followed, The Times reported.
The study was published Oct. 20 in the New England Journal of Medicine and was presented at the European Society for Medical Oncology annual meeting in Munich.
Genentech has submitted the data to the FDA to get approval of atezolizumab for treatment of triple-negative patients with the PD-L1 marker.
"This is truly a game changer," study author Dr. Sylvia Adams, from NYU Langone Health's Perlmutter Cancer Center, told The Times.
She noted that cancer patients with the PD-L1 marker tend to respond better to checkpoint inhibitors than those without it. The marker was present in 41 percent of patients in this study.
After initial treatment with chemotherapy and immunotherapy, some patients have been doing well for two or three years with immunotherapy alone, Adams told The Times.
She added that the "million-dollar question" is whether they can safely stop the immunotherapy if they have no sign of cancer. For now, they are continuing with immunotherapy.
While she has received no payments from drug companies, her medical center did receive funding from Genentech to pay for the research, Adams said.
The new study "is a big deal and has been the buzz of the breast cancer research world," Dr. Larry Norton, of Memorial Sloan Kettering Cancer Center in New York City, told The Times.
He was not involved in the study, but has done paid consulting work for the past two years for Genentech.
The study results are "very significant" and it seems that chemotherapy "takes away the invisibility cloak the cancer has managed to put on," Dr. Ingrid Mayer, a breast cancer specialist at Vanderbilt University, told The Times.
She was not part of the study, but has received consulting fees from seven drug companies, including Genentech.
The chemotherapy may help trigger the immune system, in part by killing cancer cells that then leak compounds that T-cells detect and begin to hunt, Mayer explained.
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