Trodelvy prolongs PFS in metastatic breast cancer subset, topline data show
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A phase 3 study of sacituzumab govitecan-hziy met its primary endpoint of PFS among a subset of patients with hormone receptor-positive, HER2-negative metastatic breast cancer, according to topline data released by the agent’s manufacturer.
The randomized, multicenter TROPiCS-02 study evaluated sacituzumab govitecan-hziy (Trodelvy, Gilead), a Trop-2-directed antibody-drug conjugate, vs. physician’s choice of chemotherapy among 543 patients who previously received endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.
The first interim analysis of OS in the trial showed a trend toward improvement, and patients will continue to be followed for this key secondary endpoint, according to a Gilead-issued press release. Other secondary endpoints include duration of response, clinical benefit rate, and assessment of safety, tolerability and quality-of-life measures.
Hormone receptor-positive, HER2-negative breast cancer accounts for approximately 70% of all breast cancer cases, or about 400,000 diagnoses annually throughout the world, according to the press release.
“Patients with advanced breast cancer may eventually develop endocrine resistance, then resistance to a limited set of sequential chemotherapy options,” Hope S. Rugo, MD, professor of medicine and director of breast oncology and clinical trials education at University of California, San Francisco Comprehensive Cancer Center, said in the release. “These data show the potential for Trodelvy to address an important unmet need for patients with [hormone receptor-positive]/HER2-negative metastatic breast cancer who have been heavily pretreated.”
TROPiCS-02 targeted a 30% decrease in risk for disease progression or death among this patient population. It is powered to detect a statistically significant difference of 0.9 months or more in median PFS, the press release stated.
The PFS results appeared consistent with those of the phase 1/2 IMMU-132-01 study among a subset of patients with hormone receptor-positive, HER2-negative metastatic breast cancer, according to the release.
“Trodelvy demonstrated consistent activity in this difficult-to-treat patient population,” Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, said in the release. “We are evaluating the data and will explore potential pathways with regulatory authorities to bring Trodelvy to this group of patients. As we work to expand the patient benefit of Trodelvy beyond its current indications for second-line metastatic triple-negative breast cancer and accelerated approval in second-line metastatic bladder cancer, we are pursuing studies across multiple tumor types and earlier lines of therapy.”
Sacituzumab govitecan-hziy also had a safety profile consistent with previous studies, and no new safety signals emerged, according to the release.
Detailed results of TROPiCS-02 will be presented at a future medical meeting.
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