FOSTER CITY, Calif.– Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the Phase 3 ASCENT study of Trodelvy® (sacituzumab govitecan-hziy) in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In addition to the previously reported overall survival benefit observed with Trodelvy compared with chemotherapy chosen by patients’ physicians (11.8 months vs. 6.9 months; HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), this new sub-analysis demonstrated significant and clinically meaningful improvements in health-related quality of life (HRQoL) with Trodelvy. The results were presented at the European Society of Medical Oncology (ESMO) Congress 2021 from September 16-21, 2021 (Poster #257P).
“In TNBC, limited treatment options and poor survival outcomes are compounded by a significant decrease in quality of life, especially in relapsed or refractory metastatic disease, where patients can undergo many rounds of chemotherapy,” said Sibylle Loibl, MD, Centre for Hematology and Oncology at Bethanien-Hospital Frankfurt. “Trodelvy is not only the first treatment to extend survival in these patients, but this analysis shows it can also significantly lessen the burden of symptoms when quality time is especially important.”
HRQoL was assessed at baseline, on Day 1 of each cycle, and at the end of treatment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The questionnaire measured patient perceptions of their own physical, mental and social health, which can be influenced by disease symptoms and side effects of treatment. The differences between treatment groups in mean changes from baseline were estimated using a statistical model that accounts for the baseline value and similarity in multiple measurements over time from the same patient by using on-treatment data for cycles 2 to 6.
The analysis (n=419) demonstrated that patients receiving Trodelvy (n=236) showed significant and clinically meaningful improvements in HRQoL scores, including global health status (0.66 vs. -3.42; p<0.05), physical functioning (1.31 vs. -4.39; p<0.01) and emotional functioning (3.34 vs. -0.55; p<0.05), compared with those who received physician’s choice of chemotherapy (n=183). Patients receiving Trodelvy also experienced lower symptomatic impact of fatigue (1.97 vs. 7.13; p<0.05), pain (-8.93 vs. -1.89; p<0.01), dyspnea (-3.79 vs. 3.95; p<0.01) and insomnia (-4.69 vs. 0.34; p<0.05). Only diarrhea, a known side effect, was significantly and meaningfully worse with Trodelvy (14.07 vs. -1.27; p<0.01); however, this did not appear to translate to an adverse impact on patients’ global health score or functioning.
“Many metastatic TNBC patients’ disease will quickly progress following chemotherapy, so the survival benefit with Trodelvy is highly meaningful, and the quality of that time is also very important,” said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Research, Gilead Sciences. “We are committed to improving overall outcomes for patients with this aggressive disease, including more and potentially better time when it matters most.”
The safety profile of Trodelvy was consistent with prior reports from the ASCENT study. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.
