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ePoster Display

258P - Analysis of patients (pts) without an initial triple-negative breast cancer (TNBC) diagnosis (Dx) in the phase III ASCENT study of sacituzumab govitecan (SG) in brain metastases-negative (BMNeg) metastatic TNBC (mTNBC)

Date

16 Sep 2021

Session

ePoster Display

Presenters

Joyce O'Shaughnessy

Citation

Annals of Oncology (2021) 32 (suppl_5): S457-S515. 10.1016/annonc/annonc689

Authors

J. O'Shaughnessy1, A. Brufsky2, H.S. Rugo3, S.M. Tolaney4, S. Diab5, K. Punie6, S. Sardesai7, E. Hamilton8, D. Loirat9, T.A. Traina10, R. Leon-Ferre11, S.A. Hurvitz12, K. Kalinsky13, A. Bardia14, S. Henry15, I. Mayer16, Q. Hong17, S. Phan18, J. Cortés19

Author affiliations

  • 1 Medical Oncology, Baylor University Medical Center, Texas Oncology, 75246 - Dallas/US
  • 2 Division Of Hematology/oncology, Magee-Womens Hospital and the Hillman Cancer Center, University of Pittsburgh Medical Center, 15213 - Pittsburgh/US
  • 3 Department Of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, 94115 - San Francisco/US
  • 4 Medical Oncology, Dana Farber Cancer Institute, 02215 - Boston/US
  • 5 Medical Oncology / Hematology, Rocky Mountain Cancer Centers, US Oncology, 80111 - Greenwood Village/US
  • 6 Department Of General Medical Oncology And Multidisciplinary Breast Centre, Leuven Cancer Institute, University Hospitals Leuven, 3000 - Leuven/BE
  • 7 Medical Oncology, Ohio State University Wexner Medical Center, 43210 - Columbus/US
  • 8 Tennessee Oncology, Sarah Cannon Research Institute, 37203 - Nashville/US
  • 9 Medical Oncology Department And D3i, Institut Curie, 75005 - Paris/FR
  • 10 Medical Oncology, Memorial Sloan Kettering Cancer Center, 10065 - New York/US
  • 11 Department Of Medical Oncology, Mayo Clinic, 55905 - Rochester/US
  • 12 Medical Oncology, University of California, Los Angeles, Jonsson Comprehensive Cancer Center, 90095 - Los Angeles/US
  • 13 Department Of Medicine, Winship Cancer Institute, Emory University, 30303 - Atlanta/US
  • 14 Department Of Hematology And Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, 01434 - Boston/US
  • 15 Department Of Oncology-hematology, Radiotherapy, And Nuclear Medicine, CHU UCL Namur, 5000 - Namur/BE
  • 16 Division Of Hematology/oncology, Breast Cancer Program, Vanderbilt-Ingram Cancer Center, 37011 - Nashville/US
  • 17 Department Of Clinical Development, Gilead Sciences Inc, 07950 - Morris Plains/US
  • 18 Department Of Clinical Development, Gilead Sciences Inc., 94403 - Foster City/US
  • 19 Medical Oncology Department, International Breast Cancer Center, Quiron Group, 08022 - Barcelona/ES
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Abstract 258P

Background

SG is an antibody-drug conjugate composed of an anti–Trop-2 antibody coupled to SN-38 via a unique hydrolyzable linker. In the ASCENT study, SG significantly prolonged survival vs chemotherapy of physician’s choice (TPC) in the second line or greater mTNBC setting (median progression-free survival [PFS], 5.6 vs 1.7 mo; median overall survival [OS], 12.1 vs 6.7 mo). Changes in hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status can occur during the temporal course of metastatic disease. While ASCENT required pts to have TNBC on their most recent biopsy at study entry, about one-third did not have TNBC at initial Dx. A subgroup analysis assessed outcomes with SG in these pts.

Methods

Pts with mTNBC refractory to or relapsing after ≥2 prior chemotherapies (≥1 in the metastatic setting) were randomized 1:1 to receive SG (10 mg/kg IV on d 1 and 8, every 21 d) or TPC (capecitabine, eribulin, vinorelbine, or gemcitabine). Primary endpoint was PFS per RECIST 1.1 by central review in BMNeg pts.

Results

In total 146 pts did not have TNBC at initial Dx, with 70/235 BMNeg pts (30%) who received SG, and 76/233 BMNeg pts (33%) who received TPC. Pts without TNBC at initial Dx had a median age of 55 y (range, 27-80), and 63% had ECOG PS 1. For these pts, SG significantly improved median PFS vs TPC (4.6 vs 2.3 mo; HR, 0.48; P=0.0004), median OS (12.4 vs 6.7 mo; HR, 0.44; P<0.0001), and objective response rate (31% vs 4%). Key treatment-related grade ≥3 adverse events (SG vs TPC) were neutropenia (59% vs 40%), anemia (8% vs 7%), and diarrhea (7% vs 0%). No treatment-related deaths with SG were reported. Efficacy outcomes for pts with TNBC at initial Dx similarly were improved with SG vs TPC; the safety profile was comparable.

Conclusions

The subgroup of pts without TNBC at initial Dx had a significant survival benefit with SG vs TPC, with a manageable safety profile. Outcomes were similar to those of the ASCENT trial’s overall population. Studies are ongoing to further evaluate SG in TNBC (eg, NeoSTAR, NCT04230109; SASCIA, NCT04595565; etc) and HR+/HER2-negative disease (TROPiCS-02, NCT03901339).

Clinical trial identification

NCT02574455.

Editorial acknowledgement

Legal entity responsible for the study

Gilead Sciences, Inc.

Funding

Gilead Sciences, Inc.

Disclosure

J. O'Shaughnessy: Financial Interests, Personal, Other, Consulting fees: AbbVie Inc.; Agendia Amgen Biotechnology; Aptitude Health; AstraZeneca; Bristol Myers Squibb; Celgene Corporation; Eisai; G1 Therapeutics; Genentech; Immunomedics; Ipsen Biopharmaceuticals; Lilly; Merck; Myriad; Novartis; Ondonate Therapeutics; Pfizer; P. A. Brufsky: Financial Interests, Personal, Other, Consulting fees: Immunomedics (Gilead), Novartis, Genentech, Roche, Eisai, Merck, Athenex . H.S. Rugo: Non-Financial Interests, Institutional, Research Grant, Funding for Sponsored studies to UCSF: Pfizer, Merck, Novartis, Lilly, Genentech, OBI, Odonate, Daiichi, Seattle Genetics, Eisai, Macrogenics, Sermonix, Immunomedics, AstraZeneca; Financial Interests, Personal, Other, Travel Support for Educational Meeting: Daiichi, Mylan, Pfizer, Merck, Novartis, AstraZeneca, Macrogenics; Financial Interests, Personal, Other, Honoraria: Mylan, Puma, Samsung. S.M. Tolaney: Financial Interests, Institutional, Research Grant, PI of studies(all funding to institute): Immunomedics/Gilead, AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Exelixis, Bristol Myers Squibb, Eisai, Nanostring, Cyclacel, Sanofi, Odonate; Financial Interests, Personal, Other, Honorarium for consultant/advisory board: Immunomedics/Gilead, AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Eisai, Nanostring, Odonate; Financial Interests, Personal, Other, travel expense reimbursement for ad board: Nektar; Financial Interests, Personal, Other, Honorarium for advisory board: Bristol Myers Squibb, Puma, Sanofi, Celldex, Silverback Therapeutics, G1 Therapeutics, OncoPep, Kyowa Kirin Pharmaceuticals, Daiichi Sankyo, Samsung Bioepsis Inc., Certara, Mersana Therapeutics; Financial Interests, Personal, Other, Honorarium for consulting: Seattle Genetics, AbbVie, Athenex, CytomX; Financial Interests, Personal, Other, PI of studies(all funding to institute); Honorarium for consultant/advisory board --outside this study: Immunomedics/Gilead. S. Diab: Financial Interests, Personal, Other, Speaker and advisory board: Immunomedics; Financial Interests, Personal, Other, Personal Fees: Pfizer, AstraZeneca, Genentech, Novartis, Puma Biotechnology, Amgen, Lilly, AbbVie, Eisai, Daiichi Sankyo; Non-Financial Interests, Personal, Other, Non-Financial Support: Pfizer, AstraZeneca, Genentech, Novartis, Puma Biotechnology, Amgen, Lilly, AbbVie, Eisai, Seattle Genetics; Other, Personal and Institutional, Other: Clovis Oncology. K. Punie: Financial Interests, Institutional, Other, Consulting fees: Roularta, Novartis, Roche, Medscape, Vifor Pharma, Pfizer, Pierre Fabre; Financial Interests, Institutional, Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Lilly, McCann Health, Mundi Pharma, MSD, Novartis, Pfizer, Roche; Financial Interests, Institutional, Other, Support for attending meetings and/or travel: AstraZeneca, Novartis, PharmaMar, Roche, Pfizer; Financial Interests, Institutional, Advisory Board, Participation on a Data Safety Monitoring Board or Advisory Board: AstraZeneca, Novartis, Lilly, Roche, Pierre Fabre, Vifor Pharma; Non-Financial Interests, Personal, Other, Committee member of ESMO Young Oncologists Committee: ESMO; Financial Interests, Personal, Member of the Board of Directors, Board member of Belgian Society of Medical Oncology: BSMO; Financial Interests, Institutional, Funding, Research funding to institution: Sanofi. S. Sardesai: Financial Interests, Personal, Other, Consulting fees- Payments to self: Immunomedics, Novartis, Bio Theranostics. E. Hamilton: Financial Interests, Institutional, Funding, research funding (payable to institution only, no personal funds): OncoMed, Genentech/Roche, Zymeworks, Rgenix, ArQule, Clovis, Silverback Therapeutics, Millenium, Acerta Pharma, Sermonix Pharmaceuticals, Torque, Black Diamond, Karyopharm, Infinity Pharmaceuticals, Curis, Syndax, Novartis, Boehringer Ingelheim, Immunomed; Financial Interests, Institutional, Other, consulting/advisory role payments( to institution only, no personal funds accepted): Genentech/Roche, Boehringer Ingelheim, Novartis, Dantari, Lilly, Merck, Puma Biotechnology, Silverback Therapeutics, CytomX, Pfizer, Mersana, Black Diamond, H3 Biomedicine, Daiichi Sankyo, AstraZeneca, Arvinas, Deciphera Pharmaceuticals, Eisai, Seagen. D. Loirat: Financial Interests, Personal, Other, Consulting fees: MSD, Novartis, AstraZeneca, Roche, Immunomedics, Pfizer; Financial Interests, Personal, Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Amgen, MSD, Lilly, Novartis, BMS, Roche; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Roche, MSD, AstraZeneca, Novartis; Financial Interests, Personal, Advisory Board, Participation on a Data Safety Monitoring Board or Advisory Board: MSD. T.A. Traina: Financial Interests, Personal, Other, Consulting or Advisory Role: Genentech/Roche, Pfizer, AstraZeneca, Merck, Puma Biotechnology, Advaxis, Celgene, Innocrin Pharma, Genomic Health, Bristol Myers Squibb, Athenex, Aduro Biotech, Halozyme, Daiichi Sankyo, Ionis Pharmaceuticals, Seattle Genetics, Eisai, Immunomedics; Financial Interests, Institutional, Research Grant, Research Funding: Eisai, Pfizer, Novartis, Innocrin Pharma, AstraZeneca, Astellas Pharma, Immunomedics, Genentech/Roche, Daiichi Sankyo, Carrick Pharm. R. Leon-Ferre: Non-Financial Interests, Personal, Other, Travel support to investigator's meeting: Immunomedics; Other, Personal, Other, Advisory board participation, honoraria to institution for research activities: AstraZeneca. S.A. Hurvitz: Non-Financial Interests, Institutional, Other, Contracted Research: Ambrx, Amgen, AstraZeneca, Arvinas, Bayer, Daiichi Sankyo, Genentech/Roche, Gilead, GSK, Immunomedics, Lilly, Macrogenics, NovarUs, Pfizer, OBI Pharma, Pieris, PUMA, Radius, Sanofi, SeaFle GeneUcs, Dignitana, Zymeworks, Phoenix Molecular Designs, Ltd.; Financial Interests, Personal, Stocks/Shares, Stock Options: NK Max. K. Kalinsky: Financial Interests, Institutional, Research Grant, Grants or contracts from entity: Inctye, Novartis, Genentech, Lilly, Pfizer, Calithera, immunomedics, Acetylon, Seattle Genetics, Amgen, Zeno, Cytomx; Financial Interests, Personal, Other, Consulting fees: Lilly, Pfizer, Novartis, Eisai, AstraZeneca, Genentech, Immumomedics, Merck, Seattle Genetics, Cyclacel, Oncosec; Financial Interests, Personal, Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Lilly; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Lilly, AstraZeneca, Pfizer; Financial Interests, Personal, Other, Steering Committee: Immunomedics, AstraZeneca, Genentech; Other, Personal, Other, Spouse (employee): Grail, Array, Pfizer. A. Bardia: Financial Interests, Institutional, Research Grant, Research Grant to Institution: Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, Immunomedics; Financial Interests, Personal, Other, Advisory Board/Consulting: Biothernostics Inc., Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics, Taiho, Sanofi, Daiichi Pharma/AstraZeneca, Puma, Phillips, Eli Lilly, Foundation Medicine; Financial Interests, Personal, Other, Steering Committee: Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics; Financial Interests, Personal, Other, Travel support: Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics, Taiho, Sanofi, Phillips. I. Mayer: Financial Interests, Personal, Research Grant, Research support: Pfizer, Genentech; Financial Interests, Personal, Advisory Board, Ad board: Novartis, Pfizer, Genentech, Lilly, Puma, AbbVie, Immunomedics, Macrogenics, Seattle Genetics, AstraZeneca, GSK, Cyclacel, Blueprint. Q. Hong: Financial Interests, Personal, Full or part-time Employment, Employment: Gilead Sciences, Inc.; Financial Interests, Personal, Stocks/Shares, Stock Ownership: Gilead Sciences, Inc. . S. Phan: Financial Interests, Personal, Full or part-time Employment, Employee of sponsor of the study: Immunomedics; Financial Interests, Personal, Stocks/Shares, Received as employee of company: Immunomedics. J. Cortés: Financial Interests, Personal, Advisory Board, Consulting/Advisor:: 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, Other, Honoraria: Roche +, Novartis +, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Page 2 of 4 Daiichi Sankyo.; Financial Interests, Institutional, Research Grant, Research funding to the Institution: 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, Other, Travel, accommodation, expenses: Roche, Novartis, Eisai, Pfizer, Daiichi Sankyo. All other authors have declared no conflicts of interest.

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