Trodelvy® (sacituzumab govitecan-hziy)

Health‑Related Quality of Life in mTNBC

This document is in response to your request for information regarding Trodelvy® (sacituzumab govitecan-hziy [SG]) in patients with metastatic triple-negative breast cancer (mTNBC) and health-related quality of life (HRQoL).

Some data may be outside of the US FDA-approved Prescribing Information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA approved prescribing information.

The full indication, important safety information, and boxed warnings for neutropenia and diarrhea are available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi

Summary

Product Labeling1

SG is indicated for the treatment of adult patients with unresectable locally advanced or mTNBC who have received ≥2 prior systemic therapies, ≥1 of them for metastatic disease.

HRQoL Subanalyses

The ASCENT study evaluated the efficacy and safety of SG vs chemotherapy treatment of physician’s choice (TPC) in patients with refractory or relapsed mTNBC who relapsed after ≥2 prior chemotherapies 2

HRQoL outcomes were analyzed in the SG (n=236) and TPC (n=183) study arms.3

• SG was non-inferior to TPC in all primary and secondary HRQoL domains except nausea/vomiting and diarrhea. Patients who received SG had statistically significant greater improvements in global health status/quality of life (QoL), physical functioning, pain, and fatigue.
• Patients who received SG had a significantly longer time to first clinically meaningful deterioration in physical functioning, role functioning, fatigue, and pain, as well as a significantly shorter time to first clinically meaningful improvement in physical functioning, pain, and dyspnea.

HRQoL outcomes were further analyzed by clinical response (n=82 and n=11) and non-response (n=154 and n=172) in the SG and TPC arms, respectively.4

• In most European Organization for Research and Treatment of Cancer Quality of Life Core 30 Questionnaire (EORTC QLQ-C30) domains, SG showed more favorable least-square mean (LSM) changes from baseline vs TPC regardless of clinical response status, with the exception of nausea/vomiting and diarrhea.

HRQoL Subanalyses

ASCENT Overall Study Design2

ASCENT, a global, open‑label, randomized, confirmatory, phase 3 study, evaluated the efficacy and safety of SG compared with TPC in patients with refractory or relapsed mTNBC who had received ≥2 prior chemotherapies for unresectable, locally advanced, or metastatic disease (Figure 1).

Figure 1. ASCENT Study Design2,5

Subanalysis of HRQoL Outcomes3

A subanalysis compared HRQoL outcomes between SG and TPC over the course of treatment. HRQoL was assessed using EORTC QLQ-C30 within 28 days of initiation of Cycle 1, on Day 1 of each cycle, and 4 weeks after the last dose of study drug or at study discontinuation. The primary HRQoL domains assessed were global health status/HRQoL, physical functioning, role functioning, pain, and fatigue. Other EORTC QLQ-C30 domains were evaluated as secondary HRQoL domains.

The subanalysis included all patients in the ITT population who had evaluable assessments (≥1 of the 15 EORTC QLQ-C30 domains completed) on the EORTC QLQ-C30 at initiation of Cycle 1 and ≥1 post-baseline assessment (Table 1).

Table 1. HRQoL-Evaluable Population3

Abbreviation: BRCA=breast cancer gene.

Results3

Completion rate (number of valid HRQoL assessments divided by the number of ITT patients expected to provide an HRQoL assessment) was ≥90% up to Cycle 6 and was comparable between the 2 study arms. Mean baseline scores (range: 0–100) for the primary HRQoL domains were worse than those reported in the general population of similar age and gender but were comparable between the two arms (Table 2).

Table 2. Baseline Scores for the Primary HRQoL Domains3

Abbreviation: MID=minimal important difference
Note: Bolded text indicates difference compared with the general population norm greater than the MID.

Underlined text indicates that TPC is worse than SG more than the MID.aHigher score=better HRQoL.bHigher score=better functioning.cHigher score=worse symptomatology.

SG was non-inferior to TPC for all primary and secondary HRQoL except nausea/vomiting and diarrhea. SG was superior vs TPC for global health status/QoL, physical functioning, fatigue, pain, emotional functioning, dyspnea, and insomnia (Table 3).

Table 3. Overall LSM Change from Baseline in Scores for Primary and Secondary HRQoL Domains3

Note: Bolded text indicates SG was superior to TPC based on the MID and significance testing. Underlined text indicates SG was inferior to TPC (the upper bound of the 95% CI was greater than the non-inferiority margin.

aHigher score=better HRQoL.bHigher score=better functioning.cHigher score=worse symptomology.dThe between-group MID could not be estimated, so a within-group MID based on a previously published threshold was used instead.eThe MID was derived as 0.3 x SD for the overall sample (16.8).fP<0.05.gP<0.01

The Kaplan-Meier product limit method was used to analyze time to first clinically meaningful improvement or deterioration of HRQoL (above a pre-specified threshold of 10 points). Patients who received SG had a significantly longer time to first clinically meaningful deterioration in physical functioning, role functioning, fatigue, and pain than those who received TPC (Table 4). In addition, patients who received SG had a significantly shorter time to first clinically meaningful improvement in physical functioning (HR: 1.66, P=0.01) and pain (HR: 1.41, P=0.01).

Table 4. Time to First Clinically Meaningful Deterioration in HRQoL3

      Note: Death was treated as an event.

Subanalysis of HRQoL Outcomes According to Clinical Response4

HRQoL outcomes between clinical responders and non-responders to SG and TPC over the course of treatment were assessed with EORTC QLQ-C30 using the same schedule that was summarized in the previous subanalysis. Primary HRQoL domains assessed were global health status/QoL, physical functioning, role functioning, pain, and fatigue.

This subanalysis evaluated all patients who underwent randomization and had evaluable assessments (≥1 of the 15 EORTC QLQ-C30 domains completed) on the EORTC QLQ-C30 at baseline and ≥1 post-baseline assessment. Study investigators calculated completion rates (the denominator was the number of participants expected to have an HRQoL assessment) and available data rates (the denominator was the number of participants in the ITT population). HRQoL outcomes were evaluated according to the best response achieved by patients in each treatment arm: clinical responders were those who had a best overall clinical response of partial response or complete response; non-responders had a best overall response of stable disease, progressive disease, or not evaluable. The TTD in HRQoL was defined as the time between treatment randomization and the time that a participant had a worsening from baseline of ≥10 points. Death was considered an event.

HRQoL assessments were completed by ≥90% of patients in each arm and were comparable between the 2 arms at visits up to Cycle 10. However, completion rates decreased over the study period; assessments were completed by more patients in the SG arm than in the TPC arm. Of those considered HRQoL-evaluable, 35% of patients (82/236) in the SG arm and 6% of patients (11/183) in the TPC arm were clinical responders (Table 5).

Table 5. HRQoL-Evaluable Population4

aBlack or African American, bMonths

Results4

TTD was longer among SG clinical responders than SG non-responders for all primary focused domains (Table 6). Across clinical responder groups, SG had longer TTD than TPC for HRQoL in each domain except fatigue which was similar (HR=1.03, 95% CI: 0.61-1.72). SG showed more favorable LSM changes in HRQoL scores from baseline vs TPC regardless of clinical response status, with the exception of nausea/vomiting and diarrhea.

Table 6. LSM Changes in HRQoL Scores for Primary Focused Domains4

Note: Data collected through Cycle 6, Day 1 (n≥25 in both arms) included in analysis. Between-group inferential statistical testing not performed due to the small n of TPC clinical responders. aHigher score=higher QoL. bHigher score=higher level of functioning. cHigher score=higher level of symptomology.

References

1. TRODELVY® Gilead Sciences Inc. Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use. U.S. Prescribing Information. Foster City, CA.

2. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. Apr 22 2021;384(16):1529-1541.

3. Loibl S, Loirat D, Tolaney SM, et al. Health-related quality of life in the phase III ASCENT trial of sacituzumab govitecan versus standard chemotherapy in metastatic triple-negative breast cancer. Eur J Cancer. Jan 2023;178:23-33.

4. Loibl S, Tolaney SM, Punie K, et al. Assessment of health-related quality of life by clinical response from the phase 3 ASCENT study in metastatic triple-negative breast cancer (mTNBC) [Poster P5-16-01]. Presented at: San Antonio Breast Cancer Symposium; 07-10 December 2021; San Antonio, Texas.

5. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer [Protocol]. N Engl J Med. Apr 22 2021;384(16):1529-1541.

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

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