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ePoster Display

202TiP - ASTEFANIA: A phase III study of trastuzumab emtansine (T-DM1) plus atezolizumab or placebo as adjuvant therapy in patients with residual invasive breast cancer after neoadjuvant HER2-targeted therapy and chemotherapy

Date

16 Sep 2021

Session

ePoster Display

Presenters

Peter Schmid

Citation

Annals of Oncology (2021) 32 (suppl_5): S407-S446. 10.1016/annonc/annonc687

Authors

P. Schmid1, T. Bachelot2, G. Bianchini3, N. Harbeck4, S. Loi5, Y.H. Park6, A. Prat7, L. Gilham8, T. Boulet9, N. Gochitashvili10, E. Monturus11, C. Lambertini12, B. Nyawira11, A. Knott11, S.A. Hurvitz13

Author affiliations

  • 1 Centre Of Experimental Cancer Medicine, Barts Cancer Institute-Queen Mary University of London, EC1M 6BQ - London/GB
  • 2 Medical Oncology Department, Centre Léon Bérard, 69008 - Lyon/FR
  • 3 Department Of Medical Oncology, IRCCS Ospedale San Raffaele, Milan/IT
  • 4 Breast Center, Ludwig Maximilians University - Grosshadern, 81377 - Munich/DE
  • 5 Translational Breast Cancer Genomics Lab - Research, Peter MacCallum Cancer Centre, 3000 - Melbourne/AU
  • 6 Department Of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul/KR
  • 7 Medical Oncology Department, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 8 Consumer Panel, Breast Cancer Trials Consumer Advisory Panel, New South Wales/AU
  • 9 Pdbb - Biostatistics, F.Hoffmann - La Roche Ltd, Basel/CH
  • 10 Safety Science, F.Hoffmann - La Roche Ltd, Basel/CH
  • 11 Pd Oncology, F.Hoffmann - La Roche Ltd, Basel/CH
  • 12 Oncology Biomarker Development, F.Hoffmann - La Roche Ltd, Basel/CH
  • 13 Medicine/hematology Oncology Dept., UCLA Hematology/Oncology Santa Monica, 90404 - Santa Monica/US

Resources

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Abstract 202TiP

Background

T-DM1 is the standard of care for adjuvant treatment of patients (pts) with HER2-positive early breast cancer (eBC) who have invasive residual disease after pre-operative treatment with taxane and HER2-targeted therapy. However a high unmet need remains in some higher risk subgroups (eg, inoperable or lymph node-positive, hormone receptor-negative disease) who have 3-year invasive disease-free survival (IDFS) rates of 76%. Exploratory analyses suggest that addition of the PD-L1 inhibitor atezolizumab to T-DM1 results in longer progression-free survival compared to T-DM1 alone in pts with previously treated PD-L1-positive metastatic BC. PD-L1/PD-1 inhibitors may have a different effect in eBC as they result in improved pCR in early triple-negative BC regardless of PD-L1 status. ASTEFANIA evaluates atezolizumab plus T-DM1 in PD-L1 unselected pts with higher risk residual invasive breast cancer after neoadjuvant treatment.

Trial design

ASTEFANIA (EudraCT#2020-003681-40) is a phase 3, randomized, double-blind, multicenter, study in pts with centrally confirmed HER2-positive eBC with residual invasive disease at surgery after neoadjuvant chemotherapy and HER2-directed treatment including ≥9 weeks of taxane and ≥9 weeks of trastuzumab. Eligible pts have clinical stage cT4/anyN/M0, any cT/N2–3/M0, or cT1-3/N0-1/M0 at presentation. Pts with cT1mi/T1a/T1b/N0 disease are not eligible. Those with cT1-3/N0-1 disease must have pathologic evidence of residual invasive carcinoma in axillary lymph node(s) at surgery. Within 12 weeks of primary surgery, pts are randomized 1:1 to T-DM1 3.6 mg/kg IV q3w plus atezolizumab 1200 mg IV q3w or T-DM1 3.6 mg/kg IV q3w plus atezolizumab-placebo IV q3w for 14 cycles. Radiotherapy and/or endocrine therapy is administered per local standards. Randomization is stratified by clinical stage at presentation, hormone receptor status, preoperative HER2-directed therapy, and PD-L1 status. The primary endpoint is IDFS. Secondary endpoints include overall survival, safety, and patient-reported outcomes. Approximately 1590 pts will be enrolled.

Clinical trial identification

EudraCT 2020-003681-40.

Editorial acknowledgement

Medical writing support was provided by Holly Strausbaugh, PhD of Twist Medical, LLC, and funded by F. Hoffmann-La Roche, Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

P. Schmid: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Puma; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Astellas; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Oncogenex; Financial Interests, Institutional, Research Grant: Roche; Other, Spouse - Employee: Roche. T. Bachelot: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Seagen; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Other, Steering Committee Member: Roche; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: SeaGen. G. Bianchini: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Neopharm Israel; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Genomic Health; Financial Interests, Personal, Advisory Board: EISAI; Financial Interests, Personal, Other, travel grants: Roche; Financial Interests, Personal, Other, travel grants: Pfizer; Financial Interests, Personal, Other, travel grants: AstraZeneca; Financial Interests, Personal, Other, travel grants: EISAI; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Training: MSD; Financial Interests, Personal, Training: Pfizer. N. Harbeck: Financial Interests, Personal, Advisory Role, honoraria: AstraZeneca; Financial Interests, Personal, Advisory Role, honoraria: Daiichi Sankyo; Financial Interests, Personal, Advisory Role, honoraria: Lilly; Financial Interests, Personal, Advisory Role, honoraria: MSD; Financial Interests, Personal, Advisory Role, honoraria: Novartis; Financial Interests, Personal, Advisory Role, honoraria: Pierre Fabre; Financial Interests, Personal, Advisory Role, honoraria: Pfizer; Financial Interests, Personal, Advisory Role, honoraria: Roche; Financial Interests, Personal, Advisory Role, honoraria: Sandoz/Hexal; Financial Interests, Personal, Advisory Role, honoraria: Seattle Genetics; Non-Financial Interests, Personal, Ownership Interest: West German Study Group (WSG). S. Loi: Financial Interests, Institutional, Expert Testimony, Consultant: Aduro Biotech; Financial Interests, Institutional, Advisory Board, Consultant: Novartis; Financial Interests, Institutional, Advisory Board, Consultant: GlaxoSmithKline; Financial Interests, Institutional, Advisory Board, Consultant: Roche Genentech; Financial Interests, Institutional, Advisory Board, Consultant: AstraZeneca; Financial Interests, Institutional, Advisory Board, Consultant: Silverback Therapeutics; Financial Interests, Institutional, Advisory Board, Consultant: G1 Therapeutics; Financial Interests, Institutional, Funding, Research: Novartis; Financial Interests, Institutional, Funding, Research: BMS; Financial Interests, Institutional, Funding, Research: Merck; Financial Interests, Institutional, Funding, Research: PUMA Biotechnology; Financial Interests, Institutional, Funding, Research: Eli Lilly; Financial Interests, Institutional, Funding, Research: Nektar Therapeutics; Financial Interests, Institutional, Funding, Research: AstraZeneca; Financial Interests, Institutional, Funding, Research: Seattle Genetics; Non-Financial Interests, Personal, Advisory Role, Consultant (non-renumerated): Novartis; Non-Financial Interests, Personal, Advisory Role, Consultant (non-renumerated): Bristol Myers Squibb; Non-Financial Interests, Personal, Advisory Role, Consultant (non-renumerated): Seattle Genetics; Non-Financial Interests, Personal, Advisory Role, Consultant (non-renumerated): Merck; Non-Financial Interests, Personal, Advisory Role, Consultant (non-renumerated): AstraZeneca; Non-Financial Interests, Personal, Advisory Role, Consultant (non-renumerated): Roche Genentech; Financial Interests, Institutional, Funding, Research: Roche Genentech; Financial Interests, Institutional, Advisory Board, Consultant: PUMA Biotechnologies; Financial Interests, Institutional, Advisory Board, Consultant: Pfizer; Financial Interests, Institutional, Advisory Board, Consultant: Seattle Genetics; Financial Interests, Institutional, Advisory Board, Consultant: Bristol Meyers Squibb; Financial Interests, Personal, Advisory Role, Scientific Advisory Board Member: Akamara Therapeutics; Financial Interests, Personal, Other: National Breast Cancer Foundation of Australia Endowed Chair; Financial Interests, Personal, Other: Breast Cancer Research Foundation, New York. Y.H. Park: Non-Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Institutional, Research Grant, Contracted research: AstraZeneca; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: AstraZeneca; Non-Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Institutional, Funding, Contracted research: Pfizer; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Pfizer; Non-Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Institutional, Funding, Contracted research: Roche; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Roche; Financial Interests, Personal, Other, Speaker fee: Roche; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Daiichi Sankyo; Non-Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Other, Speaker fee: Novartis; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Novartis; Non-Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Institutional, Funding, Contracted research: Merck; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Merck; Non-Financial Interests, Personal, Other, Medical writing support for this abstract: Roche. A. Prat: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Role, Consultancy: Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role, Consultancy: Pfizer; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Role, Consultancy: Novartis; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Advisory Role, Consultancy: Amgen; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Role, Consultancy: BMS; Financial Interests, Personal, Invited Speaker: Nanostring Technologies; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Advisory Role, Consultancy: Puma; Financial Interests, Personal, Advisory Role, Consultancy: Oncolytics Biotech; Financial Interests, Personal, Advisory Role, Consultancy: MSD; Financial Interests, Personal, Advisory Role, Consultancy: Guardan Health; Financial Interests, Personal, Advisory Role, Consultancy: Peptomyc; Financial Interests, Personal, Advisory Role, Consultancy: Lilly; Financial Interests, Personal, Leadership Role: Reveal Genomics, SL; Financial Interests, Institutional, Funding, Contracted research, Clinical trials: Boehringer Ingelheim; Financial Interests, Institutional, Funding, Contracted research, Clinical trials: Novartis; Financial Interests, Institutional, Funding, Contracted research, Clinical trials: Roche; Financial Interests, Institutional, Funding, Contracted research: Nanostring Tecnologies; Financial Interests, Institutional, Invited Speaker: Nanostring Tecnologies; Financial Interests, Institutional, Funding, Contracted research: Sysmex Europa GmbH; Financial Interests, Institutional, Funding, Contracted research: Medica Scientia inno. Research, SL; Financial Interests, Institutional, Funding, Contracted research: Celgene; Financial Interests, Institutional, Funding, Contracted research: Astellas; Financial Interests, Institutional, Funding, Contracted research: Pfizer; Financial Interests, Institutional, Funding, Clinical trials: Roche; Financial Interests, Institutional, Funding, Clinical trials: Amgen; Financial Interests, Institutional, Funding, Clinical trials: Daiichi Sankyo; Other, Personal, Leadership Role, Executive board: Reveal Genomics, SL; Other, Personal, Leadership Role, Executive board: Beast International Group (BIG); Other, Personal, Leadership Role, Executive board: SOLTI cooperative group; Other, Personal, Leadership Role, Patronage committee: Actitud Frente al Cáncer Foundation. L. Gilham: Financial Interests, Personal, Advisory Role: Roche; Non-Financial Interests, Personal, Advisory Role: Breast Cancer Trials (Australia & New Zealand). T. Boulet: Financial Interests, Institutional, Full or part-time Employment, Employee of PAREXEL International GmbH contracted by F. Hoffmann-La Roche Ltd.: N. Gochitashvili: Financial Interests, Personal, Full or part-time Employment: Roche. E. Monturus: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche; Financial Interests, Institutional, Sponsor/Funding: F. Hoffmann-La Roche. C. Lambertini: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd.; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd. B. Nyawira: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche. A. Knott: Financial Interests, Personal, Full or part-time Employment: Roche; Financial Interests, Personal, Stocks/Shares: Roche. S.A. Hurvitz: Financial Interests, Personal, Ownership Interest, spouse: Ideal Implant; Financial Interests, Personal, Stocks/Shares, stock options: NK Max; Financial Interests, Personal, Stocks/Shares, spouse owns: ROM Tech; Financial Interests, Institutional, Research Grant: Ambrx; Financial Interests, Institutional, Principal Investigator, local PI: Ambrx; Financial Interests, Institutional, Principal Investigator, local PI: Arvinas; Financial Interests, Institutional, Principal Investigator, local PI: AstraZeneca; Financial Interests, Institutional, Principal Investigator, coordinating PI: Bayer; Financial Interests, Institutional, Principal Investigator, coordinating PI: Daiichi Sankyo; Financial Interests, Institutional, Principal Investigator, local PI: Dignitana; Financial Interests, Institutional, Principal Investigator, local PI: Genentech/Roche; Financial Interests, Institutional, Principal Investigator, local PI: Gilead; Financial Interests, Institutional, Principal Investigator, local PI: GSK; Financial Interests, Institutional, Principal Investigator, local PI: Immunomedics; Financial Interests, Institutional, Principal Investigator, local PI: Lilly; Financial Interests, Institutional, Principal Investigator, local PI: Macrogenics; Financial Interests, Institutional, Principal Investigator, local PI: Novartis; Financial Interests, Institutional, Principal Investigator, local PI: OBI Pharma; Financial Interests, Institutional, Principal Investigator, local PI: Pfizer; Financial Interests, Institutional, Principal Investigator, local PI: Phoenix Molecular Designs, Ltd; Financial Interests, Institutional, Principal Investigator, local PI: Pieris; Financial Interests, Institutional, Principal Investigator, local PI: PUMA; Financial Interests, Institutional, Principal Investigator, local PI: Radius; Financial Interests, Institutional, Research Grant: Samumed; Financial Interests, Institutional, Principal Investigator, local PI: Sanofi; Financial Interests, Institutional, Principal Investigator, local PI: Seattle Genetics; Financial Interests, Institutional, Principal Investigator, local PI: Zymeworks.

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