March 8, 2022
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Health
Trodelvy prolongs PFS in metastatic breast cancer subsets, top-line data
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Phase 3 trials of Sacituzumab gobitecan-hziy meet the primary endpoint of PFS in a subset of patients with hormone receptor-positive, HER2-negative metastatic breast cancer, according to top-line data released by the drug manufacturer. rice field.
Randomized multicenter TROPiCS-02 study evaluated sacituzumab govitecan-hziy (Trodelvy, Gilead)Physician chemotherapy selection among 543 patients who received antibody-drug conjugates, anti-endocrine therapy, CDK4 / 6 inhibitors and 2-4 lines of chemotherapy directed to Trop-2.
According to a press release issued by Gilead, the first interim analysis of OS in the trial showed a trend of improvement, and patients will continue to be followed for this primary secondary endpoint. Other secondary endpoints include assessment of duration of response, clinical benefit rate, safety, tolerability, and quality of life.
According to the press release, hormone receptor-positive and HER2-negative breast cancers account for about 70% of all breast cancer cases, and about 400,000 people are diagnosed each year worldwide.
Hope S. Lugo
“Patients with advanced breast cancer may eventually develop endocrine resistance and then resistance to a limited set of continuous chemotherapy options.” Want S. Rugo, MD, A professor of medicine at the University of California, San Francisco Cancer Center and head of breast oncology and clinical trial education said in a presentation. “These data show that Trodelvy has the potential to address the unmet needs of patients. [hormone receptor-positive]Severe pretreatment / HER2-negative metastatic breast cancer. “
TROPiCS-02 aimed to reduce the risk of disease progression or death in this patient population by 30%. According to the press release, a statistically significant difference in median PFS of 0.9 months or more can be detected.
According to the release, PFS results appeared to be consistent with the results of the Phase 1/2 IMMU-132-01 trial in a subset of patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
“Trodelvy has shown consistent activity in this difficult-to-treat patient population.” Merdad Parsey, MD, PhD, Gilead Sciences Chief Medical Officer said in the release. “We are evaluating the data and will investigate potential routes with regulatory agencies to bring Trodelvy to this group of patients. Trodelvy patients benefit from a second line of metastatic triple negative. We are working to extend beyond the current indications for breast cancer and to expedite approval on the second line. Metastatic bladder cancer, We are conducting research across multiple tumor types and early treatments. “
Sacituzumab govite can-hziy also has a safety profile consistent with previous studies, and according to the release, no new safety signals emerged.
Detailed results of TROPiCS-02 will be announced at a future medical conference.
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