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Observational Study
. 2024 Nov;208(1):203-214.
doi: 10.1007/s10549-024-07412-9. Epub 2024 Jun 21.

Real-world use patterns, effectiveness, and tolerability of sacituzumab govitecan for second-line and later-line treatment of metastatic triple-negative breast cancer in the United States

Kevin Kalinsky  1 , Laura Spring  2 , Clinton Yam  3 , Manali Ajay Bhave  4 , Ioanna Ntalla  5 , Catherine Lai  6 , Nikoleta Sjekloca  7 , Brian Stwalley  8 , Michael Stokes  9 , Aliki Taylor  5 , Rita Nanda  10
Affiliations
Observational Study

Real-world use patterns, effectiveness, and tolerability of sacituzumab govitecan for second-line and later-line treatment of metastatic triple-negative breast cancer in the United States

Kevin Kalinsky et al. Breast Cancer Res Treat. 2024 Nov.

Abstract

Purpose: Patients with metastatic triple-negative breast cancer (mTNBC) have poor prognosis and limited treatment options. Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, is approved for patients with mTNBC who have received ≥ 2 systemic therapies (≥ 1 in the metastatic setting) based on the ASCENT study (NCT02574455). The current study describes real-world SG use and outcomes in patients with mTNBC in the United States.

Methods: This retrospective, observational study included adult patients with mTNBC from the ConcertAI Patient360™ database who received SG in the second line (2L) and later from April 2020 to May 2022. SG use patterns, effectiveness, and tolerability are described.

Results: This analysis included 230 patients (median age 60 years, 26% Black, 17% with ECOG performance status ≥ 2, 66% in community settings; median of 2 prior lines of treatment in the metastatic setting); median follow-up was 7.2 months. Median (95% CI) real-world overall survival was 10.0 (8.3-11.1) months for all patients and 13.9 (9.8-not estimable) months in the 2L subgroup (n = 77). Granulocyte-colony stimulating factor (G-CSF) was administered concomitantly with SG in 134 (58%) patients; 35 (15%) received G-CSF for the first time. Median (IQR) time from SG start to G-CSF use was 8.5 (8.0-29.0) days. Seventeen (7%) patients discontinued SG due to toxicity.

Conclusions: Using a real-world, ethnically diverse population of patients with mTNBC presenting with poor prognosis, these data reinforced the findings from ASCENT. In routine clinical practice, SG is an effective treatment in the 2L setting, consistent with treatment guidelines.

Keywords: Metastatic; Real-world clinical outcomes; Sacituzumab govitecan; Second-line; Treatment patterns; Triple-negative breast cancer.

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Conflict of interest statement

KK reported consulting/advisory/speaker role for Daiichi Sankyo, Eli Lilly, Pfizer, Novartis, Eisai, AstraZeneca, Immunomedics, Merck, Seattle Genetics, Cyclacel, OncoSec, 4D Pharma, Puma, Genentech, Ascendant, Myovant, Takeda, and Menarini; and owns Grail stock options. LS reported consulting/advisory role Novartis, Puma, G1 Therapeutics, Daiichi Pharma, AstraZeneca, and Eli Lilly; research grants, paid to her institution, with Merck, Genentech, Gilead Sciences, Inc., and Eli Lilly. CY reported consulting/advisory role for Gilead Sciences, Inc.; research grant from GSK; and additional, non-financial interests from Amgen, Astellas, Genentech, Gilead Sciences, Inc., Merck, Novartis, and Pfizer. MAB reported consulting/advisory/speaker role for AstraZeneca, Daiichi Sankyo, Pfizer, OncLive, Curio, Targeted Oncology, and Merck. IN, CL, NS, BS, and AT are employees of Gilead Sciences, Inc. and own Gilead Sciences, Inc. stock options. MS is an employee of Evidera; Evidera has received funding from Gilead Sciences, Inc. for conducting the analysis of this study. RN reported consulting/advisory role for AstraZeneca, BeyondSpring, Daiichi Sankyo, Fujifilm, GE, Gilead Sciences, Inc., Infinity, iTeos, MacroGenics, Merck, Novartis, OBI Pharma, OncoSec, Pfizer, Sanofi, Seagen, and Stemline; and research grants from Arvinas, AstraZeneca, Celgene, Corcept Therapeutics, Genentech/Roche, Gilead/Immunomedics, Merck, Novartis, OBI Pharma, OncoSec, Pfizer, Relay, Seattle Genetics, Sun Pharma, and Taiho.

Figures

Fig. 1
Fig. 1
Patient selection. 1L, first-line, 2L second-line, BC breast cancer, ER estrogen receptor, HER2 human epidermal growth factor receptor 2, mBC metastatic breast cancer, mTNBC metastatic triple-negative breast cancer, PR progesterone receptor, SG sacituzumab govitecan. *Within 30 days prior to, on, or after the first mBC date and during the index period. †Up to 5 years prior to index date (except for non-metastatic, non-melanoma skin cancer). ‡Between 30 days prior to the first ever BC diagnosis date and ≤ 90 days after the index date. ||Biomarker test results closest to the index date were prioritized
Fig. 2
Fig. 2
rwOS (a), TTNTD (b), and rwPFS (c) in patients with mTNBC who received 2L and laterline SG treatment. 2L second-line, CI confidence interval, mTNBC metastatic triple-negative breast cancer, rwOS real-world overall survival, rwPFS real-world progression-free survival, SG sacituzumab govitecan, TTNTD time to next treatment or death
Fig. 3
Fig. 3
rwOS in patients with mTNBC who received SG in 2L (a) or 3L + (b). 2L second-line, 3L + third-line and later line, CI confidence interval, mTNBC metastatic triple-negative breast cancer, NE not estimable, rwOS real-world overall survival, SG sacituzumab govitecan
See this image and copyright information in PMC

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