At the 2023 ASCO Annual Meeting, Sara Tolaney, MD, MPH, Dana-Farber Cancer Institute, Boston, Massachusetts, presented the final overall survival analysis from the randomized, phase 3 TROPiCS-02 study, evaluating sacituzumab govitecan among patients with pretreated metastatic hormone receptor (HR)-positive, HER2-negative breast cancer.

In this analysis, with a median follow-up duration of 13 months, Dr Tolaney reports that sacituzumab govitecan continued to show improvement in both progression-free survival and overall survival. Dr Tolaney concluded, “Given these data, it does suggest that sacituzumab [govitecan] represents a very effective therapeutic option for our patients who have pretreated, metastatic hormone receptor-positive breast cancer.”

Transcript:

My name is Sara Tolaney. I'm a breast medical oncologist at Dana-Farber Cancer Institute. And at ASCO this year, we presented the final overall survival analysis from the TROPiCS-02. TROPiCS-02 is a randomized phase 3 study comparing sacituzumab govitecan to treatment of physicians choice chemotherapy in patients with pretreated metastatic hormone receptor-positive disease.

Eligible patients were required to have received prior CDK4/6 inhibition, prior endocrine therapy, prior taxane, and two to four prior lines of chemotherapy, and then were randomized in a one-to-one fashion to receive sacituzumab or treatment of physicians choice chemotherapy with the primary endpoint being progression-free survival and key secondary endpoints, including overall survival and objective response rate.

We've previously presented the primary outcome data from the trial, which demonstrated that sacituzumab led to an improvement in progression-free survival. We've also previously presented the outcomes from the second interim analysis showing that sacituzumab led to an improvement in overall survival with an absolute difference between the two arms of 3.2 months.

At this time, we're presenting the final overall survival analysis, which has a median follow-up time of 13 months. At this current analysis, we demonstrated that sacituzumab continued to have a benefit in terms of progression-free survival going from four to 5.5 months, and continued to have an improvement in overall survival going from 11.2 to 14.5 months. We also were able to look at outcomes by TROP-2 IHC status, as well as by HER2 IHC status and really showed that the survival outcomes were independent of TROP-2 and HER2 expression.

And so I think overall these findings really suggest that sacituzumab continues to have improvement in PFS and OS. Now with longer follow-up, there are also no new toxicity signals that emerged with the longer follow-up. And so I think given these data, it does suggest that sacituzumab represents a very effective therapeutic option for our patients who have pretreated metastatic hormone receptor-positive breast cancer.

Source:

Tolaney SM, Bardia A, Marmé F, et al. Final overall survival (OS) analysis from the phase 3 TROPiCS-02 study of sacituzumab govitecan (SG) in patients (pts) with hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer (mBC). Presented at 2023 ASCO Annual Meeting; June 2-6, 2023; Chicago, IL.