FDA Approves Trodelvy for HER2-Negative, HR-Positive Metastatic Breast Cancer

The Food and Drug Administration (FDA) approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of patients with unresectable (not eligible to be surgically removed) locally advanced or metastatic (spread to other parts of the body) hormone receptor (HR)-positive, HER2-negative breast cancer.

Of note, patients should have been pretreated with an endocrine-based therapy and at least two other drugs in the metastatic setting, according to a press release from Gilead, the drug’s manufacturer.

“Despite decades of advances, people living with pretreated HR-positive, HER2-negative metastatic breast cancer need new treatment options,” said 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, in the release. “Nearly all people with this type of breast cancer will eventually develop resistance to endocrine-based therapies and progress on available chemotherapies.”

The FDA approval is based on findings from the randomized phase 3 TROPiCS-02 trial, which compared Trodelvy to treatment of physician’s choice in patients with HR-positive, HER2-negative breast cancer whose disease did not respond or stopped responding to prior treatment.

Findings showed that in patients with Trop-2 (the protein on cancer cells that Trodelvy targets) expression of 100 or more, the average progression-free survival, which is defined as time from treatment until disease grows or spreads, was 6.4 months in the Trodelvy group, and 4.2 months in the treatment of physician’s choice group, according to the presentation of data at the 2022 ESMO Congress.

“This approval is significant for the breast cancer community,” said Rugo, who was principal investigator for the TROPiCS-02 study. “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 three months with a quality-of-life benefit for these women is exceptional.”

Overall survival, which is defined as the time from treatment until death of any cause, was also improved with Trodelvy. Those who had a Trop-2 expression of 100 or more had an average overall survival of 14.4 months on Trodelvy, compared with 11.2 months with the treatment of physician’s choice. Patients treated with Trodelvy also had a 34% reduction in the risk of disease progression or death (5.5 months versus four months).

Of note, the side effect profile of Trodelvy was similar to what was seen in other studies, according to the release. The most frequent side effects that occurred in at least 1% of patients was diarrhea (5%), neutropenia (3%), febrile neutropenia (4%), abdominal pain (2%), neutropenic colitis (2%), pneumonia (2%), colitis (2%) and vomiting (2%).

“The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director of SurvivingBreastCancer.org, in the release. “We need to combat this terrible disease, and all options that potentially slow its progress and extend live for those living with metastatic breast cancer are welcomed.”
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