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Sacituzumab govitecan improves outcomes when compared to physician’s choice of treatment in patients with endocrine-resistant, hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, results from the phase 3 TROPiCS-02 study suggest.
Sacituzumab govitecan reduced the risk of progression or death by 35% and the risk of death by 21%, according to Sara M. Tolaney, MD, of the Dana-Farber Cancer Institute in Boston.
“These data reinforce that SG [sacituzumab govitecan] remains an effective therapeutic option for patients with pretreated, endocrine-resistant, metastatic breast cancer,” Dr Tolaney added. She presented these results from TROPiCS-02 at the ASCO Annual Meeting 2023.
The trial (ClinicalTrials.gov Identifier: NCT03901339) enrolled patients with metastatic or locally recurrent and inoperable HR-positive, HER2-negative breast cancer that had progressed after at least 1 endocrine therapy, taxane, and CDK4/6 inhibitor, and after at least 2 (but no more than 4) lines of chemotherapy for metastatic disease.
A total of 543 patients were randomly assigned to receive physician’s choice of treatment (n=271) or sacituzumab govitecan (n=272). Baseline characteristics were well balanced between the arms.
Sacituzumab govitecan was given at 10 mg/kg on days 1 and 8 every 21 days. Physician’s choice of treatment included capecitabine, vinorelbine, gemcitabine, or eribulin. Patients received treatment until progression or unacceptable toxicity.
Prior results from this trial showed a significant improvement in progression-free survival (PFS) and overall survival (OS) with sacituzumab govitecan.
In the current analysis, the median PFS was 5.5 months in the sacituzumab govitecan arm and 4.0 months in the physician’s choice arm (hazard ratio [HR], 0.65; 95% CI, 0.53-0.81; P =.0001).
The 6-month PFS rate was 45.6% in the sacituzumab govitecan arm and 29.4% in the physician’s choice arm. The 12-month PFS rates were 21.7% and 8.4%, respectively. The 18-month PFS rates were 14.4% and 4.7%, respectively.
The median OS was 14.5 months in the sacituzumab govitecan arm and 11.2 months in the physician’s choice arm (HR, 0.79; 95% CI, 0.65-0.95; P =.0133).
The 6-month OS rate was 60.9% in the sacituzumab govitecan arm and 47.1% in the physician’s choice arm. The 12-month OS rates were 39.2% and 31.7%, respectively. The 18-month OS rates were 25.7% and 21.1%, respectively.
The improvements with sacituzumab govitecan were seen regardless of Trop-2 expression level and HER2 status. Improvements were seen across other subgroups as well. The possible exception was patients without visceral metastasis, though this group was small (n=26), which complicates interpretation.
Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 74% of patients in the sacituzumab govitecan arm and 60% of patients in the physician’s choice arm. TEAEs led to treatment delays in 66% and 44%, respectively. TEAEs led to treatment discontinuation in 6% and 4%, respectively
There were 6 fatal TEAEs in the sacituzumab govitecan arm, and 1 was considered related to treatment. There were no fatal TEAEs in the physician’s choice arm.
Disclosures: This research was supported by Gilead Sciences. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
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). ASCO 2023. June 2-6, 2023. Abstract 1003.
This article originally appeared on Cancer Therapy Advisor
