1553O - Health-related quality of life (HRQoL) in the phase III TROPiCS-02 trial of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (MBC)

Background

The antibody-drug conjugate SG comprises an anti-Trop-2 antibody coupled to SN-38 via a hydrolyzable linker. In the ongoing randomized TROPiCS-02 trial, SG is being evaluated vs single-agent chemotherapy treatment of physician’s choice (TPC) after CDK 4/6 inhibitor, endocrine therapy, and at least 2 chemotherapies in HR+/HER2- MBC setting. Here we assess the impact of SG on HRQoL in TROPiCS-02.

Methods

Patients (pts) with locally determined HR+/HER2- MBC following (2-4 prior chemotherapies) for metastatic disease, were randomized to receive SG (10 mg/kg IV on days 1 and 8 of a 21-day treatment [Tx] cycle) or TPC (capecitabine, eribulin, gemcitabine, or vinorelbine). HRQoL was assessed at baseline (BL), day 1 of each Tx cycle (CxDx) and at end of treatment visit using the EORTC QLQ-C30. The analysis included all pts with valid HRQoL assessments at BL and ≥1 post-BL visit. Linear mixed-effect models for repeated measures were used to estimate differences in overall least-square mean changes from BL between Tx arms, using on-Tx data up to C11D1 (n ≥25 in both arms).

Results

The analysis included 446 pts (236 SG, 210 TPC; median age 56 y). The EORTC QLQ-C30 completion rate was ≥85% up to C13D1 in both Tx arms. Mean HRQoL scores at BL were generally similar for SG and TPC. The SG arm showed a trend of improvement in most HRQoL domains. A significantly greater improvement in physical functioning and dyspnea was observed for SG vs TPC and greater worsening in diarrhea (table). Table: 1553O

EORTC QLQ-C30 least-square mean change from baseline

SG, sacituzumab govitecan; TPC, treatment of physician’s choice.

Conclusions

Despite the association with worsening diarrhea, SG demonstrated an overall HRQoL benefit in heavily-pretreated patients with HR+/HER2- MBC.

Clinical trial identification

NCT03901339.

Editorial acknowledgement

Legal entity responsible for the study

Gilead Sciences, Inc.

Funding

Gilead Sciences, Inc.

Disclosure

H.S. Rugo: Financial Interests, Personal, Invited Speaker: Puma Biotechnology, Mylan, Samsung Bioepis; Financial Interests, Institutional, Funding: Macrogenics, OBI Pharma, Pfizer, Novartis, Lilly, Genetech, Merck, Odonate Therapeutics, Daiichi Sankyo, Seattle Genetics, Sermonix Pharmaceuticals, Astra Zeneca, Gilead Sciences, Ayala Pharmaceuticals. P. Schmid: Financial Interests, Institutional, Research Grant, Grant/Funding to Institution: Astellas, AstraZeneca, Genentech, Novartis, Oncogenex, Roche, Medivation; Financial Interests, Personal, Advisory Role, Consulting fees: AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, Puma, Roche, Eisai, Celgene; Financial Interests, Personal, Writing Engagements, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, Puma, Roche, Eisai, Celgene; Financial Interests, Personal, Full or part-time Employment, Employee – Roche (spouse): Roche (spouse). S.M. Tolaney: Financial Interests, Institutional, Funding, Funding to institute for duration of study: Gilead; Financial Interests, Institutional, Funding, All funding to institute: AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Gilead, Exelixis, BMS, Eisai, Nanostring, Cyclacel, Sanofi, Odonate, SeaGen; Financial Interests, Personal, Invited Speaker, Honorarium payments to self for participation in advisory boards/consulting from all companies listed: AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Gilead, BMS, Eisai, Nanostring, Sanofi, Odonate, SeaGen, Daiichi-Sankyo, Athenex, CytomX, Blueprint Medicines, Zentalis, Zymeworks, Ellipses Pharma, 4D Pharma, OncoSec, Infinity Therapeutics, BeyondSpring Pharma, OncXerna, Reveal Genomics, ARC Therapeutics; Financial Interests, Personal, Invited Speaker, Honorarium payments to self for participation in advisory boards/consulting from all companies listed – 1 time event: Kyowa Kirin Pharma, G1 Therapeutics, Silverback Therapeutics, Certara, Mersana Therapeutics, OncoPep; Financial Interests, Personal, Invited Speaker, To self – lecture/educational series: Chugai, Genentech/Roche, Eisai, Gilead, AstraZeneca, BMS. F. Marmé: Financial Interests, Institutional, Funding: Pfizer; Financial Interests, Personal and Institutional, Research Grant: Roche, Novartis, Astra Zeneca, GSK/Tesaro, MED, Clovis, Vaccibody, Gilead Sciences, Eisai; Financial Interests, Personal, Advisory Role, Consulting Fees: Astra Zeneca, Tesaro/GSK, Pfizer, EISAI, Gilead, Genomic Health; Financial Interests, Institutional, Advisory Role, Consulting Fees: VACIIBODY; Financial Interests, Personal, Invited Speaker, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Astra Zeneca, Clovis, GSK/Tesaro, Eli Lilly, Novartis, Pfizer, Roche, Myriad Genetics, PharmaMar, Eisai, MSD, Immunomedis/Gilead, Pierre-Fabre, Agendia, Genomic Health, Seattle Genetics; Financial Interests, Personal and Institutional, Sponsor/Funding, Support for attending meetings and/or travel: Pfizer, Roche, Astra Zeneca ; Financial Interests, Personal and Institutional, Advisory Role, Participation on a Data Safety Monitoring Board or Advisory Board: Palleos, Amgen. L. Shi: Financial Interests, Personal and Institutional, Funding, Evidera received payment for statistical analysis for this project: Gilead. W. Verret: Financial Interests, Personal, Full or part-time Employment: Genentech, Gilead; Financial Interests, Personal, Stocks/Shares: Genentech. M. Gharaibeh: Financial Interests, Personal, Full or part-time Employment, Gilead employee – therefore, granted with Gilead stocks and stocks options: Gilead. A. Bardia: Financial Interests, Personal and Institutional, Research Grant, Grants or contracts from any entity: Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health/Menarini, Immunomedics/Gilead, Daiichi Pharma/Astra Zeneca, Eli Lilly; Financial Interests, Personal, Advisory Role, Consulting fees: Pfizer, Novartis, Genentech, Merck, Radius Health/Menarini, Immunomedics/Gilead, Sanofi, Daiichi Pharma/Astra Zeneca, Phillips, Eli Lilly, Foundation Medicine. J. Cortés: Financial Interests, Personal, Advisory Role: Roche +, Celgene -, Celestial, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, Merck Sharp&Dohme +, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Kyowa Kirin; Financial Interests, Personal, Invited Speaker: Roche +, Novartis +, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Daiichi Sankyo; Financial Interests, Institutional, Funding: Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London; Financial Interests, Personal, Stocks/Shares, Stock, patents and intellectual property: MedSIR; Financial Interests, Personal, Travel, accommodation, expenses: Roche, Novartis, Eisai, pfizer, Daiichi Sankyo. All other authors have declared no conflicts of interest.