Trodelvy Elicits Significant Survival Improvement in A Group of Patients With Pre-Treated Metastatic Breast Cancer

Treatment with Trodelvy (sacituzumab govitecan-hziy) induced a significant survival improvement over physician’s choice of chemotherapy in a group of patients with previously treated HR-positive, HER2-negative metastatic breast cancer, according to a press release from Gilead Sciences, the drug’s manufacturer.

“These survival results from the TROPiCS-02 study are important for the breast cancer community and we are encouraged by the potential this may have in helping patients who otherwise have limited alternatives,” said Dr. Merdad Parsey, the chief medical officer at Gilead Sciences, in the release. “We look forward to discussing these results with global health authorities, as pre-treated HR-positive/HER2-negative metastatic disease patients currently have limited treatment options and poor quality of life.”

This news comes from updated findings from a second interim analysis of the phase 3 TROPiCS-02 clinical trial. Here, approximately 543 patients with HR-positive, HER2-negative metastatic breast cancer that has failed to respond to endocrine therapy, CDK 4/6 inhibitors and two to four lines of chemotherapy, were randomized to receive either Trodelvy or physician’s choice of chemotherapy.

The main goal of the TROPiCS-02 trial is to measure if there is a progression-free survival (time from date of treatment randomization to first documented disease progression or death) benefit with Trodelvy versus physician’s choice of chemotherapy.

One of the other focuses of the trial is to assess if treatment with Trodelvy elicits a better overall survival (time from the date of treatment randomization to death from any cause) outcome in patients with previously treated HR-positive, HER2-negative metastatic breast cancer.

Although Gilead Sciences did not reveal the data pertaining to overall survival at this time, the manufacturer noted that the findings will be presented at an upcoming medical meeting.

In June, results that highlighted the progression-free survival benefit associated with Trodelvy versus physician’s choice of chemotherapy were presented at a major medical conference.

As disease stops responding to endocrine therapies, the primary treatment option available to patients with HR-positive, HER2-negative metastatic breast cancer has been single-agent chemotherapy, according to the release. And although these patients can continue to receive multiple rounds of chemotherapy, prognosis is often poor, according to Gilead Sciences.

The safety profile, according to Gilead Sciences, with Trodelvy in TROPiCS-02 was consistent with previous studies of the drug, and nothing new was reported. Of note, the drug has a box warning for severe or life-threatening neutropenia and severe diarrhea.

A boxed warning is issued by the Food and Drug Administration (FDA) to bring attention to the potential for major risks associated with a drug. Although Trodelvy is FDA-approved for certain patients with triple-negative breast cancer, it is not approved anywhere in the world for patients with pre-treated HR-positive, HER2-negative metastatic breast cancer.

Gilead Sciences has submitted a supplemental Biologics License Application (a request to distribute a biologic across state lines) to the FDA for Trodelvy in this patient population.

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