A new "smart drug" has shown promise for women with metastatic triple-negative breast cancer based on data from a clinical trial at NewYork-Presbyterian / Columbia's Herbert Irving Comprehensive Cancer Center and other centers. Data from the trial was published today in New England Journal of Medicine .
"I think this drug has the potential to change practice because the data looks so convincing, even with the relatively small number of patients in the trial," said Kevin Kalinsky, MD, MS Adjunct Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, an oncologist at the NewYork-Presbyterian / Columbia University Irving Medical Center and the paper's senior author.
"There is an undisputed need for patients with metastatic triple-negative breast cancer, and we see significant shrinkage with this new therapy," Kalinsky adds.
Triple-negative breast cancer is an aggressive disease and is more common in relation to other breast cancers in young women and African-American women. Triple-negative breast cancer does not express the estrogen receptor, progesterone receptor or HER2. Historically, treatments included only chemotherapy for triple-negative breast cancer and non-targeted therapy such as hormone therapy or Herceptin.
The drug sacituzumab govitecan is part of an emerging class of "smart substances" designed to deliver a toxic payload directly to tumor cells. The drug is a fusion of an antibody that recognizes a protein expressed by breast cancer cells known as trop2 and the metabolite of an established chemotherapy drug (irinotecan), SN-38. The antibody delivers SN-38 directly to the cancer cell.
Kalinsky says that "with this smart drug we can deliver a much higher dose of payload as we send it directly to the cancer cells."
The sample tested the drug in 1
When a patient has started his third or fourth treatment regimen, the chance of a response is low. Sacituzumab govitecan, however, produced a better response rate in pre-treated patients than was historically seen with other standard therapies.
Overall, 33 percent of patients responded to the drug; the median duration of response was 7.7 months; and median survival was 13 months. [Note: The trial only tested sacituzumab govitecan; a randomized Phase II/III clinical trial comparing sacituzumab govitecan to other drugs is ongoing].
"We saw significant shrinkage with the drug and it took longer for the cancer to develop over other drugs commonly used to treat metastatic triple-negative breast cancer," says Kalinsky. Nine prolonged respondents remained free of disease for more than a year.
"Having smaller tumors can be incredibly meaningful for a patient's quality of life," adds Kalinsky. "When tumors shrink, patients are more likely to experience improvement in symptoms, such as pain."
The main side effects seen in the study were hair loss, diarrhea and fatigue, but only 3 percent of patients had to stop taking drugs due to adverse events.
"It is important that the drug did not cause neuropathy, numbness and tingling that can be quite painful and limiting for the patients," says Kalinsky. "Neuropathy can make it difficult to dress or even walk. It is promising to have an active treatment that does not have neuropathy as a side effect."
The drug is also tested in other forms of breast cancer, bladder cancer and prostate cancer.
"We are delighted to have participated in the early development of this new drug, which we hope will change the treatment paradigm to patients with metastatic triple-negative breast cancer," said Gary Schwartz, MD, Head of Hematology / Oncology at New York. Presbyterian / Columbia University Irving Medical Center and Deputy Director of NewYork-Presbyterian / Columbia's Herbert Irving Comprehensive Cancer Center.
The paper is called "Sacituzumab Govitecan-hziy for refractory metastatic triple negative breast cancer," and was published online in New England Journal of Medicine .
Some patients with metastatic triple negative breast cancer live longer with immunotherapy
New England Journal of Medicine (2019). dx.doi.org/10.1056/NEJMoa1814213
Columbia University Irving Medical Center
New "smart drug" shows promise of metastatic triple-negative breast cancer (2019, February 20)
February 22, 2019
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