Sacituzumab govitecan meets primary endpoint 

Sacituzumab govitecan delivered superior progression-free survival (PFS) data compared with chemotherapy in patients with heavily pre-treated HR-positive/HER2-negative advanced breast cancer. The primary results of the phase 3 TROPiCS-02 trial support the use of this agent in heavily pre-treated breast cancer patients who have limited treatment options. 

“In patients with advanced HR-positive/HER2-negative breast cancer who are resistant to endocrine therapy, single-agent chemotherapy is the standard-of-care,” mentioned Prof. Hope Rugo (University of California San Francisco, CA, USA). However, chemotherapy options are limited in later lines, resulting in an unmet clinical need [1]. The TROPiCS-02 trial (NCT03901339) randomised patients with HR-positive/HER2-negative metastatic breast cancer, who had received endocrine therapy, a CDK4/6 inhibitor, and 2–4 prior lines of chemotherapy, to sacituzumab govitecan, a first-in-class trop-2-directed antibody-drug conjugate (n=272) or chemotherapy by physician’s choice (capecitabine, eribulin, vinorelbine, or gemcitabine; n=271) [2]. The PFS by independent central review was the primary outcome of this study.

The primary endpoint was met: Treatment with sacituzumab govitecan resulted in a significantly improved median PFS compared with chemotherapy (5.5 vs 4.0 months; HR 0.66; P=0.0003), reflecting a 34% reduced risk of disease progression in the sacituzumab govitecan group. In the same line, the 12-month PFS rates were 21.3% for sacituzumab govitecan and 7.1% for chemotherapy. This result was consistent across predefined strata. The overall survival data trended towards a benefit for sacituzumab govitecan (13.9 vs 12.3 months; HR 0.84; P=0.14), however, this data was not yet mature at the time of this analysis. Furthermore, the overall response rate was higher in the experimental arm compared with the control arm (21% vs 14%; P=0.03).

“The safety profile of sacituzumab govitecan in this study was consistent with that observed in previous studies of this agent,” said Prof. Rugo. Treatment-emergent adverse events (TEAEs) ≥ grade 3 occurred in 74% and 60% of the patients in the experimental arm and control arm, respectively. The number of TEAEs leading to treatment discontinuation was low, with 6% and 4% in the respective treatment groups. Neutropenia (51%) and diarrhoea (9%) were the most common ≥ grade 3 TEAEs in the experimental arm.

“Sacituzumab govitecan demonstrated statistically significant and clinically meaningful benefits and should be considered as a potential treatment option in the heavily pre-treated advanced breast cancer population with limited treatment options,” concluded Prof. Rugo.

1. Gennari A, et al. Ann Oncol. 2021;32(12):1475–1495.
2. Rugo HS, et al. Primary results from TROPiCS-02: A randomized phase 3 study of sacituzumabgovitecan (SG) versus treatment of physician’s choice (TPC) in patients (Pts) with hormone receptor–positive/HER2-negative (HR+/HER2-) advanced breast cancer. LBA1001, ASCO 2022 Annual Meeting, 3–7 June, Chicago, IL, USA.

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Posted on 5 August 2022