A new "smart drug" has been shown to be promising for women with metastatic triple negative breast cancer, based on data from a clinical trial conducted at the Herbert Cancer Center. Irving from NewYork-Presbyterian / Columbia and other centers. The test data was published today in the New England Journal of Medicine.
"I think this drug has the potential to change the practice because the data seem so convincing, even with the relatively small number of patients included in the trial," says Kevin Kalinsky, MD, MS, assistant professor of medicine at Columbia University of Vagelos. Physicians and surgeons, oncologist at Irving NewYork-Presbyterian Medical Center / Columbia University and lead author of the paper.
"There is an unmet need for patients with triple-negative metastatic breast cancer and we are seeing significant narrowing of the tumor with this new treatment," Kalinsky adds.
Triple negative breast cancer is an aggressive disease and is more prevalent, compared to other breast cancers, among young women and African-American women. Triple negative breast cancers do not express estrogen receptors, progesterone receptors or HER2 receptors. Thus, historically, treatments included only chemotherapy for triple negative breast cancer and not targeted therapy, such as hormone therapy or Herceptin.
The drug, sacituzumab govitecan, is part of an emerging class of "smart drugs" 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 called trop2 and the metabolite of an established chemotherapy drug (irinotecan), the SN-38. The antibody releases SN-38 directly into the cancer cell.
Kalinsky said that "with this smart drug, we can provide a much larger dose of payload since we send it directly to the cancer cells".
The trial tested the drug in 108 women with triple-negative metastatic breast cancer who had previously undergone two or more previous regimens.
When a patient has started their third or fourth treatment, the risk of response is low. Sacituzumab govitecan, however, produced a better response rate in pretreated patients than was observed in the past with other conventional treatments.
Overall, 33% of patients responded to the drug; the median duration of response was 7.7 months; and the median overall 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 have seen a significant narrowing of the tumor with the drug, and the cancer has taken longer to progress than other drugs commonly used to treat triple-negative metastatic breast cancer," said Kalinsky. Nine long-term respondents remained unaffected by disease progression for more than one year.
"Having smaller tumors can have an incredible impact on the quality of life of a patient," Kalinsky adds. "When tumors contract, patients are more likely to experience an improvement in symptoms, such as pain."
Hair loss, diarrhea and fatigue were the main adverse events observed during the trial. Only 3% of patients had to stop taking the drug because of side effects.
"Importantly, the drug did not cause neuropathy, numbness, or tingling, which can be very painful and limiting for patients," says Kalinsky. "Neuropathy can make it difficult to dress oneself up, or even to walk in. It's promising to have active treatment that does not cause neuropathy as a side effect."
The drug is also tested in other types 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 paradigm of treating patients with triple-negative metastatic breast cancer," he said. Gary Schwartz, MD, Head of the Hematology / Oncology Department at New York-Presbyterian. / Irving Medical Center at Columbia University and Deputy Director of the New York-Presbyterian / Herbert Irving Cancer Center in Columbia.
The document titled "Sacituzumab Govitecan-hziy for refractory triple refractory metastatic breast cancer" and was published online in the Journal 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
Irving Medical Center at Columbia University
New "smart drug" promising for triple negative metastatic breast cancer (February 20, 2019)
recovered on February 21, 2019
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