Final study analysis of the TROPiCS-02 trial support Trodelvy as “a standard treatment” for patients.
Treatment with Trodelvy (sacituzumab govitecan) significantly improved survival among some patients with breast cancer, according to the findings of a recent international trial.
Final study analysis of the phase 3 TROPiCS-02 clinical trial, published in the journal The Lancet , showed that among patients with metastatic hormone receptor(HR)-positive, HER2-negative breast cancer, who had been previously treated with endocrine therapy and chemotherapy, treatment with the targeted therapy Trodelvy resulted in a median overall survival (the time following treatment that a patient is still alive) of 14.4 months, versus 11.2 months among participants treated with chemotherapy.
The objective response rate (patients whose disease responded to treatment) was 21% among patients treated with Trodelvy, compared with 14% of patients treated with chemotherapy. Trodelvy treatment also resulted in a 34% reduction in the risk of disease progression or death, according to the authors.
Trodelvy targets the Trop-2 antigen commonly found on breast cancer cells, and researchers noted that the “overall survival benefit for (Trodelvy) over chemotherapy was also seen regardless of Trop-2 expression.”
“These data reinforce that (Trodelvy) is leading to improvements in both progression-free (how long a patient lives without the disease worsening) and overall survival and that patients saw benefit irrespective of their tumor’s Trop-2 expression,” Dr. Sara Tolaney, chief of the division of breast oncology at the Susan F. Smith Center for Women’s Cancers at the Dana-Farber Cancer Institute and the study’s senior author, said in a news release from Dana-Farber. “This updated analysis continues to support (Trodelvy) as a standard treatment for patients with pretreated, endocrine-resistant HR+/HER2- metastatic breast cancer.”
With 543 participants at more than 100 study locations in the United States, Canada, Europe and the United Kingdom, TROPiCS-02 launched in 2019, according to its listing on clinicaltrials.gov. Participants had a median age of 56 years, and a median time of 47.8 months from initial metastatic diagnosis to randomization in the study.
The Food and Drug Administration (FDA) approved Trodelvy for the for the treatment of patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer in February, based on results from TROPiCS-02.
“Despite decades of advances, people living with pretreated HR-positive, HER2-negative metastatic breast cancer need new treatment options,” Dr. Hope S. Rugo, professor of medicine and director of breast oncology and clinical trials education at the UCSF Helen Diller Family Comprehensive Cancer Center, said in a press release from Trodelvy manufacturer Gilead at the time. “Nearly all people with this type of breast cancer will eventually develop resistance to endocrine-based therapies and progress on available chemotherapies.”
The FDA had previously approved Trodelvy for the treatment of adults with unresectable (inability to be surgically removed) locally advanced or metastatic triple-negative breast cancer who had received at least two prior therapies, including at least one for metastatic disease, in 2021.
Study authors noted that the safety profile of Trodelvy was “consistent with previous studies,” and stated that there was one death of septic shock caused by neutropenic colitis that had been determined to be related to treatment with Trodelvy.
According to the study, the most common side effects of any grade included neutropenia (a low number of neutrophils, a type of white blood cell), diarrhea, nausea, alopecia (hair loss) and anemia (low levels of red blood cells).
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