FDA expands Trodelvy approval for breast cancer
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The FDA expanded the approval of sacituzumab govitecan-hziy to include treatment of certain patients with hormone receptor-positive disease.
Sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) is a Trop-2-directed antibody-drug conjugate.
The FDA previously approved the agent for treatment of certain patients with metastatic triple-negative breast cancer or metastatic urothelial cancer.
The new indication applies to use of sacituzumab govitecan-hziy to treat patients with unresectable locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer who received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
The FDA based the approval on results of the randomized phase 3 TROPiCS-02 study, which included 543 patients with hormone receptor-positive, HER2-negative advanced disease. All patients experienced disease progression after a cyclin-dependent kinase 4/6 inhibitor, endocrine therapy and taxane in any setting. They also received at least two prior chemotherapies in the metastatic setting.
Researchers randomly assigned patients 1:1 to sacituzumab govitecan (n = 272), dosed at 10 mg/kg IV on days 1 and 8 every 21 days, or physician’s choice of treatment (n = 271). Physician’s choice options included capecitabine, eribulin, vinorelbine or gemcitabine.
Treatment continued until disease progression or unacceptable toxicity.
PFS by blinded independent central review served as the primary endpoint. OS, response, duration of response, safety and quality of life served as secondary endpoints.
As Healio previously reported, the primary analysis showed median PFS of 5.5 months with sacituzumab govitecan vs. 4 months with physician’s choice (HR = 0.66; 95% CI, 0.52-0.82).
Results of the second planned interim analysis showed median OS of 14.4 months with sacituzumab govitecan vs. 11.2 months with physician’s choice (HR = 0.78; 95% CI, 0.64-0.96).
A higher percentage of those assigned sacituzumab govitecan-hziy remained progression free at 1 year (21% vs. 7%).
“Despite decades of advances, people living with pretreated [hormone receptor-positive, HER2-negative] metastatic breast cancer need new treatment options. Nearly all people with this type of breast cancer will eventually develop resistance to endocrine-based therapies and progress on available chemotherapies,” Hope S. Rugo, MD, director of breast oncology and clinical trials education at UCSF Helen Diller Family Comprehensive Cancer Center and principal investigator of the TROPiCS-02 study, said in a Gilead Sciences-issued press release. “This approval is significant for the breast cancer community. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than 3 months with a quality-of-life benefit for these women is exceptional.”
The most common adverse events that occurred among patients treated with sacituzumab govitecan-hziy in TROPiCS-02 included decreased leukocyte count (88%), decreased neutrophil count (83%), decreased hemoglobin (73%), decreased lymphocyte count (65%), diarrhea (62%), fatigue (60%), nausea (59%), alopecia (48%), increased glucose (37%), constipation (34%) and decreased albumin (32%).
References:
- FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer. Published Feb. 3, 2023.
- U.S. FDA approves Trodelvy in pre-treated HR+/HER2- metastatic breast cancer (press release). Available at: https://www.gilead.com/news-and-press/press-room/press-releases/2023/2/us-fda-approves-trodelvy-in-pretreated-hrher2-metastatic-breast-cancer. Published Feb. 3, 2023.
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