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Poster session 15

392P - Quality-adjusted time without symptoms of disease progression or toxicity of treatment (Q-TWiST) analysis to assess benefit-risk of sacituzumab govitecan (SG) in previously treated patients (pts) with metastatic triple-negative breast cancer (mTNBC)

Date

14 Sep 2024

Session

Poster session 15

Topics

Tumour Site

Breast Cancer

Presenters

Adam Brufsky

Citation

Annals of Oncology (2024) 35 (suppl_2): S357-S405. 10.1016/annonc/annonc1579

Authors

A.M. Brufsky1, A. Bardia2, M.S. Sedrak3, S. Loibl4, S.M. Tolaney5, K. Punie6, S.A. Hurvitz7, K. Kalinsky8, J. Cortés9, J. O'Shaughnessy10, V.C. Dieras11, M. Piccart12, A. Dasgupta13, A.G. Kaushik13, C. Lai14, L. Shi15, H.S. Rugo16

Author affiliations

  • 1 Department Of Hematology/oncology, Magee-Womens Hospital and the Hillman Cancer Center, University of Pittsburgh Medical Center, 15232 - Pittsburgh/US
  • 2 Division Of Medical Oncology, UCLA Health Jonsson Comprehensive Cancer Center, 90024 - Los Angeles/US
  • 3 Division Of Medical Oncology, Ucla Health Jonsson Comprehensive Cancer Center, Cancer and Aging Program, David Geffen School of Medicine, UCLA, 90095-1781 - Los Angeles/US
  • 4 German Breast Group, Forschungs, Germany, Neu-Isenburg and Centre for Haematology and Oncology Bethanien, 63263 - Frankfurt/DE
  • 5 Department Of Medical Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 6 Department Of General Medical Oncology And Multidisciplinary Breast Centre, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium;, Laboratory of Experimental Oncology, Department of Oncology, KU Leuven, 2000 - Leuven/BE
  • 7 Division Of Hematology And Oncology, Department Of Medicine, UW Medicine, Clinical Research Division, Fred Hutchinson Cancer Center, WA 98109 - Seattle/US
  • 8 Winship Cancer Institute, Emory University, 30322 - Atlanta/US
  • 9 International Breast Cancer Center, Quironsalud Group, Barcelona/ES
  • 10 Baylor University Medical Center, Texas Oncology, US Oncology, 75246 - Dallas/US
  • 11 Centre Eugene Marquis Unicancer, Rennes Cedex, 35042 - Rennes/FR
  • 12 Institut Jules Bordet, Université Libre de Bruxelles, 1000 - Brussels/BE
  • 13 Department Of Health Economics Outcomes Research, Gilead Sciences, Inc., 94404 - Foster City/US
  • 14 Department Of Clinical Development, Gilead Sciences, Inc., 94404 - Foster City/US
  • 15 Department Of Patient Centered Research, Evidera Inc, 20814 - Bethesda/US
  • 16 Department Of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, 94158 - San Francisco/US

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Abstract 392P

Background

The phase 3 ASCENT trial included previously treated pts with mTNBC and demonstrated significantly prolonged overall and progression-free survival for SG vs chemotherapy treatment of physician’s choice (TPC). Rate of treatment emergent adverse events (TEAEs) was similar in SG and TPC arms. The objective of this analysis was to assess benefit and risk of SG vs TPC while accounting for pt quality of life in ASCENT.

Methods

Q-TWiST analysis was used to compare SG vs TPC. Survival time was partitioned into 3 health states: 1) with toxicity (TEAE ≥ 3) before disease progression until the earliest of TEAE being resolved, disease progression, death, or end of follow-up; 2) without toxicity before disease progression; and 3) disease progression until death or end of follow-up, whichever was first. Health state utilities were derived from published literature. A sensitivity analysis was performed with TEAE ≥ 2. Q-TWiST was calculated as utility-weighted sum of mean health state durations. Differences in Q-TWiST and relative Q-TWiST gains were assessed. Relationship between pt follow-up time vs Q-TWiST gain and difference in time spent in toxicity (SG vs TPC) was determined. The established threshold for relative Q-TWiST gain considered clinically important is 10% and clearly clinically important 15%.

Results

SG had significantly longer Q-TWiST (8.3 months [mo]; 95% CI, 7.6-9.1) than TPC (4.8 mo; 95% CI, 4.3-5.4) in pts with mTNBC, a difference of 3.5 mo (95% CI, 2.6-4.4; P <. 0001). Relative Q-TWiST improvement with SG was 39.5%. Q-TWiST benefits of SG over TPC increased with longer follow-up to week 138. Restricted mean time with toxicity was numerically higher with SG vs TPC, remaining stable with longer follow-up. In the sensitivity analysis SG had significantly longer median Q-TWiST vs TPC (difference 3.3 mo (95% CI, 2.3-4.1; P <. 0001) and relative Q-TWiST improvement was 36.5%.

Conclusions

SG demonstrated statistically significant and clearly clinically meaningful improvement in Q-TWiST compared to TPC in pts with previously treated mTNBC. Net benefits of SG continued to accrue with longer follow-up.

Clinical trial identification

NCT02574455.

Editorial acknowledgement

Medical writing and editorial support was provided by Ben Labbe, PhD, of Parexel.

Legal entity responsible for the study

Gilead Sciences, Inc.

Funding

Gilead Sciences, Inc.

Disclosure

A.M. Brufsky: Financial Interests, Personal, Advisory Board: Gilead, Astrazeneca, Novartis, Lilly, Pfizer, Daiichi Sankyo, Roche/Genentech, Puma, Eisai, Merck; Financial Interests, Personal, Other, Consultant: Sanofi, General Electric; Financial Interests, Institutional, Local PI: Astrazeneca, Daiichi Sankyo, Lilly, Roche/Genetech; Financial Interests, Institutional, Steering Committee Member: Gilead, Puma. A. Bardia: Financial Interests, Personal, Advisory Board: Pfizer, Novartis, Genentech, Merck, Sanofi, Eisai, Lilly, Mersana, AstraZeneca/Daiichi, Menarini, Gilead; Financial Interests, Personal, Royalties: UpToDate; Financial Interests, Institutional, Coordinating PI: Genentech, Novartis, Pfizer, Merck, Sanofi, Gilead, Daiichi Pharma/AstraZeneca, Eli Lilly, Menarini; Non-Financial Interests, Principal Investigator: Gilead, Mersana, AstraZeneca/Daiichi, Novartis, Pfizer, Genentech, Lilly, Merck, Sanofi. M.S. Sedrak: Financial Interests, Institutional, Coordinating PI, Eli Lilly investigator-initiated trial: Eli Lilly. S. Loibl: Financial Interests, Institutional, Advisory Board, Member: Amgen, AstraZeneca, BMS, Celgene, DSI, EirGenix, GSK, Lilly, Pierre Fabre, Roche, Seagen, Abbvie, Sanofi, Gilead, Merck, Novartis, Relay Therapeutics; Financial Interests, Institutional, Invited Speaker: AstraZeneca, DSI, Novartis, Pfizer, Roche, Gilead, Seagen, Stemline-Menarini; Financial Interests, Institutional, Advisory Board: Pfizer, Olema; Financial Interests, Personal, Invited Speaker: Medscape; Financial Interests, Personal, Full or part-time Employment, CEO: GBG Forschungs GmbH; Financial Interests, Institutional, Advisory Board, Ki67 Quantifier: VMscope GmbH; Financial Interests, Institutional, Research Grant: AstraZeneca, Celgene, Novartis, Immunomedics/Gilead, Pfizer, Roche, Daiichi Sankyo; Financial Interests, Institutional, Funding: AbbVie, Molecular Health, Greenwich Life Sciences; Financial Interests, Personal, Other, PIPenelope/Padma: Pfizer; Financial Interests, Personal, Other, SC PALOMA3: Pfizer; Financial Interests, Personal, Other, SC SOLAR1: Novartis; Financial Interests, Personal, Other, SC ASCENT: Immunomedics/Gilead; Financial Interests, Personal, Other, SC HERCLIMB: Seagen; Financial Interests, Personal, Other, SC Katherine: Roche; Financial Interests, Personal, Other, SC Capitello; EC Cambria 1: AstraZeneca; Financial Interests, Personal, Other, SC Inavo: Roche; Financial Interests, Personal, Other, SC Destiny B05; SC Destiny B09: Daiichi Sankyo; Non-Financial Interests, Principal Investigator, After publication of primary endpoint: PI Aphinity; Non-Financial Interests, Advisory Role, Group in Germany responsible for breast cancer guidelines: AGO Kommission Mamma; Non-Financial Interests, Member, German Gynaecological Oncology society: AGO; Non-Financial Interests, Member, German Cancer Society: DKG; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Member, Member guideline committee; past chair in ESMO Breast: ESMO; Other, EP14153692.0No financial interest, Institutional: Patent; Other, EP21152186.9No financial interest, institutional: Patent; Other, EP19808852.8 No financial interest, Institutional: Patent. S.M. Tolaney: Financial Interests, Personal, Advisory Board, Ad board participant/consultant: ARC Therapeutics, Daichii Sankyo, Eisai, Genentech/Roche, Gilead, Novartis, Sanofi, Seagen; Financial Interests, Personal, Other, Consulting: Aadi BioPharma, Hengrui USA; Financial Interests, Personal, Advisory Board, Ad board participation: Artios, Incyte Corp, BeyondSprings; Financial Interests, Personal, Advisory Board, Ad Board Participant/Consultant: AstraZeneca, Eli Lilly; Financial Interests, Personal, Advisory Board, Advisory Board participation: Bayer, Infinity Therapeutics, Sumitovant Biopharmaceuticals, OncXerna, Umoja Biopharma, Zentalis, Natera; Financial Interests, Personal, Other, Consultant: Blueprint Medicines; Financial Interests, Personal, Advisory Board, Ad board participant: Bristol-Myers Squibb; Financial Interests, Personal, Other, Steering Committee Member/Consultant: CytomX; Financial Interests, Personal, Advisory Board, Advisory Board participation/consulting: Menarini/Stemline; Financial Interests, Personal, Advisory Board, Ad Board participant/consultant: Merck; Financial Interests, Personal, Advisory Board, Ad board participant/Consultant: Pfizer; Financial Interests, Personal, Advisory Board, Advisory board participation: Reveal Genomics; Financial Interests, Personal, Advisory Board, Advisory Board Participation: Zymeworks; Financial Interests, Personal, Advisory Board, Advisory board/consulting: Jazz Pharma; Financial Interests, Personal, Advisory Board: Tango Therapeutics, Systimmune, eFFECTOR, Cullinan Oncology, Arvinas; Financial Interests, Institutional, Funding, And steering committing: AstraZeneca; Financial Interests, Institutional, Funding, And steering committee: Eli Lilly; Financial Interests, Institutional, Funding: Pfizer, Sanofi, Seagen, Odonate, Cyclacel, Exelixis, Bristol Myers Squibb, Eisai, Merck, Novartis; Financial Interests, Personal and Institutional, Steering Committee Member: CytomX; Financial Interests, Institutional, Funding, and steering committee: Gilead, Genentech/Roche; Financial Interests, Institutional, Local PI: Stemline/Menarini. K. Punie: Financial Interests, Institutional, Advisory Board: AstraZeneca, Novartis, Roche, Vifor Pharma, Eli Lilly, Pierre Fabre, McCann Health, Roularta, Teva, Gilead Sciences, Pfizer, Gilead, MSD; Financial Interests, Institutional, Invited Speaker: Pfizer, Roche, Novartis, Eli Lilly, Mundi Pharma, MSD, Medscape; Financial Interests, Institutional, Other, Consultancy: Roche; Financial Interests, Personal, Other, Consultancy: Gilead, Novartis, MSD, Roche; Financial Interests, Personal, Invited Speaker: Sanofi, AstraZeneca, Exact Sciences, Focus Patient, Pfizer, Gilead Sciences, Eli Lilly, Eli Lilly, Medimix; Financial Interests, Personal, Advisory Board: Seagen, AstraZeneca, Pfizer; Financial Interests, Institutional, Funding: Sanofi; Non-Financial Interests, Leadership Role, Vice President: Belgian Society of Medical Oncology BSMO; Non-Financial Interests, Other, Committee Member: ESMO Resilience Task Force; Non-Financial Interests, Leadership Role: EORTC Breast Cancer Task Force Steering Committee Member; Non-Financial Interests, Advisory Role: Commission personalized medecine Federal Government Belgium; Non-Financial Interests, Advisory Role, External Scientific Advisor: European Medicine Agency. S.A. Hurvitz: Financial Interests, Personal, Invited Speaker: Clinical Care Options, axis medical, cancer expert now, ICHE, MJH Associates, PER, Primo, Projects in Knowledge, Prova Education, Research to Practice, Ultimate Medical Academy, Vaniam, WebMD, Peer Education, PrecisCA, Peer Voice, Curio, Reach MD/MedIQ, Imedex, MD Outlook, Prime Oncology, Reach MD, OncLive; Financial Interests, Personal, Stocks/Shares, spouse owns: ROM Tech; Financial Interests, Personal, Royalties, author medical book: McGraw; Financial Interests, Personal, Royalties: Elsevier, Springer, Sage, Wolters Kluwer, Wiley; Financial Interests, Institutional, Local PI: Ambrx, AstraZeneca, Arvinas, Genentech/Roche, Gilead, GSK, Immunomedics, Eli Lilly, Macrogenics, Novartis, Pfizer, OBI Pharma, Pieris, PUMA, Radius, sanofi, Seattle Genetics, Dignitana, Zymeworks, Phoenix Molecular Designs, Ltd, cytomx, Dantari, G1 Therapeutics, Greenwich Life Sciences, Loxo Oncology, orinove, Orum; Financial Interests, Institutional, Coordinating PI: Daiichi Sankyo, Celcuity; Financial Interests, Institutional, Research Grant: Ambrx; Financial Interests, Steering Committee Member: Greenwich Life Sciences, Orum; Non-Financial Interests, Advisory Role: Daiichi Sankyo, Novartis, Ambrx, 4DPharma, Dantari, Macrogenics, Lilly, Artios, Roche, Pyxis, Amgen, Pieris, Arvinas, Immunomedics/Gilead, Briacell, Jazz Pharmaceuticals, Boehringer Ingelheim, Stemline/Menarini; Non-Financial Interests, Principal Investigator: Daiichi Sankyo, Genentech, Seattle Genetics; Non-Financial Interests, Member: ASCO, AACR; Non-Financial Interests, Other, speaker: National Breast Cancer Coalition; Non-Financial Interests, Member, site representative for breast cancer guidelines: National Comprehensive Cancer Network. K. Kalinsky: Financial Interests, Personal, Advisory Board: Daiichi Sankyo, Eli-Lilly, Pfizer, Novartis, Eisai, AstraZeneca, Immunomedics, Merck, Seattle Genetics, Cyclacel, Oncosec, 4D Pharma, Puma; Financial Interests, Personal, Stocks/Shares, Employment + Stock = spouse: Grail; Financial Interests, Personal and Institutional, Local PI, Consultant: Novartis, Eli-Lilly, AstraZeneca, daicchi sankyo; Financial Interests, Personal and Institutional, Local PI, consultant: Genentech; Financial Interests, Institutional, Local PI, consultant: Pfizer; Financial Interests, Institutional, Local PI: Seattle Genetics, Ascentantage; Financial Interests, Personal, Other, Consultant: Myovant, Takeda, Menarini, Prelude; Financial Interests, Personal, Other, consultant: RayzeBio; Other, Support for attending meetings and/or travel: Eli-Lilly, AstraZeneca, Pfizer; Other, Steering Committee: Immunomedics, AstraZeneca, Ambryx, Genentech. J. Cortés: Financial Interests, Personal, Advisory Board, consulting/advisor: Roche, Astrazeneca, Seattle Genetics, Daiichi Sankyo, Lilly, MERCK SHARP& DOHME, LEUKO, Bioasis, Clovis oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies, Jazz Pharmaceuticals, Abbvie, Scorpion Therapeutics, Bridgebio, Biocon, Biontech; Financial Interests, Personal, Invited Speaker: Roche, Novartis, Eisai, Pfizer, Lilly, MERCK SHARP& DOHME, Daiichi Sankyo, Astrazeneca, Gilead, Steamline Therapeutics; Financial Interests, Personal, Stocks/Shares: MAJ3 Capital; Financial Interests, Personal, Stocks/Shares, (relative): Leuko; Financial Interests, Institutional, Research Grant: Roche, Ariad Pharmaceuticals, Astrazeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Queen Mary University of London, Iqvia; Other, Travel cost and expenses: Roche, Novartis, Eisai, Daiichi Sankyo, Pfizer, Gilead, Astrazeneca, Steamline Therapeutics; Other, travel cost and expenses: Merck Sharp&Dhome. J. O'Shaughnessy: Financial Interests, Personal, Advisory Board: Abbvie, Agendia, Amgen, Aptitude Health, AstraZeneca, Eisai, G1 Therapeutics, Lilly, Merck, Novartis, Pfizer, Puma, Roche, Carrick Therapeutics, Daiichi Sankyo, Gilead Sciences, Ontada, Pierre Fabre Pharmaceuticals, Samsung Bioepis, Sanofi, BioNtech, Byondis, Dava Oncology, Fishawack Health, Genzyme, GSK, Genentech, Loxo Oncology, Seagen, Stemline Therapeutics, Taiho Oncology, Veru; Financial Interests, Personal, Other, Advisory Board: BioNTech, Duality. V.C. Dieras: Financial Interests, Personal, Advisory Board, National advisory board: Pierre Fabre Oncologie; Financial Interests, Personal, Advisory Board, Steering Committee, consultant, Symposium, travel expenses: Roche Genentech; Financial Interests, Personal, Advisory Board, + Symposia and travel expenses: Novartis; Financial Interests, Personal, Advisory Board, Advisory boards, symposia, travel expenses: Pfizer; Financial Interests, Personal, Advisory Board, Symposia, travel expenses: Lilly, AstraZeneca, MSD; Financial Interests, Personal, Advisory Board, Symposia,travel expenses: Daiichi Sankyo; Financial Interests, Personal, Advisory Board, symposia,travel expenses: Seagen, Gilead; Financial Interests, Personal, Advisory Board, Steering Committee: AbbVie; Financial Interests, Personal, Advisory Board: Eisai, Medac GmbH; Financial Interests, Personal, Other, IDMC: Sanofi; Financial Interests, Personal, Advisory Board, national board: MENARINI; Financial Interests, Personal and Institutional, Other, IDMC: Sanofi; Financial Interests, Institutional, Steering Committee Member: Roche Genentech; Financial Interests, Institutional, Coordinating PI, Steering Committee: Lilly; Financial Interests, Institutional, Coordinating PI: AstraZeneca; Financial Interests, Institutional, Coordinating PI, + IDMC: Daiichi Sankyo; Financial Interests, Institutional, Steering Committee Member, PI: Seagen. M. Piccart: Financial Interests, Personal, Invited Speaker: AstraZeneca, Lilly, MSD, Novartis, Pfizer; Financial Interests, Personal, Advisory Board: Menarini, Seattle Genetics, Seagen, Gilead, NBE Therapeutics, Frame Therapeutics; Financial Interests, Personal, Advisory Board, Consultant and invited speaker: Roche-Genentech; Financial Interests, Personal, Member of Board of Directors, Scientific Board: Oncolytics; Financial Interests, Institutional, Research Grant: AstraZeneca, Lilly, Gilead; Financial Interests, Institutional, Funding: Menarini, MSD, Novartis, Pfizer, Radius, Roche-Genentech, Servier, Synthon. A. Dasgupta: Financial Interests, Institutional, Full or part-time Employment: Gilead Sciences; Financial Interests, Institutional, Stocks/Shares: Gilead Sciences. A.G. Kaushik: Financial Interests, Institutional, Full or part-time Employment: Employee of Gilead Sciences; Financial Interests, Institutional, Stocks/Shares: Stockholder of Gilead Sciences. C. Lai: Financial Interests, Personal, Full or part-time Employment: Gilead Sciences; Financial Interests, Personal, Stocks/Shares: Roche, Gilead Sciences. L. Shi: Financial Interests, Institutional, Full or part-time Employment, Receiving salary from this company: Evidera, Inc; Financial Interests, Institutional, Stocks/Shares, Receiving stocks as an employee: Evidera, Inc. H.S. Rugo: Financial Interests, Personal, Advisory Board, Consultancy/advisory support: NAPO; Financial Interests, Personal, Invited Speaker, Honoraria: Mylan/Viatris, Chugai; Financial Interests, Personal, Advisory Board, Advisory/Consultancy: PUMA, Sanofi; Financial Interests, Institutional, Local PI: Novartis, Lilly, Pfizer, Daiichi Sankyo, AstraZeneca Gilead Sciences, Inc.; Financial Interests, Institutional, Coordinating PI: OBI Pharma, F. Hoffmann-La Roche AG/Genentech, Inc., Merck; Financial Interests, Institutional, Research Grant: Stemline Therapeutics, Ambryx.

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