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E-Poster Display

293P - Impact of tucatinib on progression free survival in patients with HER2+ metastatic breast cancer and stable or active brain metastases

Date

17 Sep 2020

Session

E-Poster Display

Presenters

Thomas Bachelot

Citation

Annals of Oncology (2020) 31 (suppl_4): S348-S395. 10.1016/annonc/annonc268

Authors

T. Bachelot1, N.U. Lin2, R.K. Murthy3, S.A. Hurvitz4, V. Borges5, M. Oliveira6, C. Oakman7, S. Khan8, C. Lynch9, K. Westbrook10, C. Doyle11, M. Reinisch12, M.A. Colleoni13, D. Slamon4, G.N. Hortobagyi3, E.P. Winer2, S. McGoldrick14, X. An15, S. Loibl16

Author affiliations

  • 1 Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 2 Medical Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 3 Breast Medical Oncology, MD Anderson Cancer Center, 77030 - Houston/US
  • 4 Medical Oncology, UCLA Medical Center/Jonsson Comprehensive Cancer Center, 90095 - Los Angeles/US
  • 5 Medicine-medical Oncology, University of Colorado Cancer Center, Aurora/US
  • 6 Medical Oncology, Vall d'Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO, 08035 - Barcelona/ES
  • 7 Department Of Oncology, Sunshine Hospital, 3021 - Victoria/AU
  • 8 Medical Oncology, Nottingham University Hospitals NHS Trust, Nottingham/GB
  • 9 Medical Oncology, Cancer Treatment Centers of America - Phoenix, 85338 - Goodyear/US
  • 10 Department Of Medicine, Duke University Medical Center, 27710 - Durham/US
  • 11 Hematology/oncology, Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval, G1S4L8 - Quebec City/CA
  • 12 Breast Unit, Kliniken Essen Mitte Evang. Huyssens-Stiftung, 45136 - North Rhine-Westphalia/DE
  • 13 Medical Oncology, Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 14 Clinical Development, Seattle Genetics, Inc., 98121 - Seattle/US
  • 15 Biostatistics, Seattle Genetics, Inc., 98021 - Bothell/US
  • 16 Department Of Medicine And Research, German Breast Group (GBG) Forschungs GmbH, 63263 - Neu-Isenburg/DE
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Resources

Abstract 293P

Background

Up to 50% of HER2+ metastatic breast cancer (MBC) pts will develop brain metastases (BM) for which effective treatments are needed. In the HER2CLIMB (NCT02614794) double-blind trial, tucatinib (TUC) added to trastuzumab (T) and capecitabine (C) resulted in statistically significant improvements in PFS and OS in HER2+ MBC pts with and without BM (Murthy, NEJM 2019). Risk of disease progression or death in BM pts was 52% lower in the TUC arm vs. the control arm (P<0.001). We present exploratory analyses of PFS by type of BM in HER2CLIMB.

Methods

HER2CLIMB pts were randomized 2:1 to receive TUC or placebo combined with T and C. All pts had baseline brain MRI. BM were classified as untreated, treated stable, or treated and progressing. PFS per investigator and OS were analyzed by treatment arm in stable BM pts (treated stable) and active BM pts (untreated + treated progressing), using standard RECIST 1.1 assessing disease in both body and brain.

Results

At baseline, 291 pts (48%) had BM: 198 (48%) in the TUC arm and 93 (46%) in the control arm. In pts with stable BM (n=117), risk of disease progression or death was reduced by 44% in the TUC arm (HR: 0.56; 95% CI: 0.33, 0.96; P=0.03); median (95% CI) PFS was 7.5 mo (5.4, 9.6) in the TUC arm vs. 5.0 mo (2.0, 5.6) in the control arm. In pts with active BM (n=174), risk of disease progression or death was reduced by 62% in the TUC arm (HR: 0.38; 95% CI: 025, 0.58; P<0.00001); median PFS was 7.6 mo (5.7, 8.5) in the TUC arm vs. 4.1 mo (3.1, 4.3) in the control arm. In pts with treated progressing BM (n=108), risk of disease progression or death was reduced by 64% in the TUC arm (HR: 0.36; 95% CI: 0.21, 0.63; P=0.0002); median PFS was 7.6 mo (5.7, 9.6) in the TUC arm vs. 4.1 mo (3.1, 4.3) in the control arm. In pts with untreated BM (n=66), risk of disease progression or death was reduced by 53% in the TUC arm (HR: 0.47; 95% CI: 0.24, 0.92; P=0.02); median PFS was 6.9 mo (5.5, 9.6) in the TUC arm vs. 3.6 mo (1.5, 7.5) in the control arm.

Conclusions

Addition of TUC to T and C significantly improved PFS regardless of BM type, indicating delay of progression not only in the body but also in the brain. Patients with active BM (typically excluded from HER2+ MBC trials) had substantially longer PFS with TUC treatment.

Clinical trial identification

NCT02614794.

Editorial acknowledgement

Medical writing assistance was funded by Seattle Genetics, Inc., and provided by Laurie LaRusso, MS, ELS, Chestnut Medical Communications.

Legal entity responsible for the study

Seattle Genetics.

Funding

Seattle Genetics.

Disclosure

T. Bachelot: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Seattle Genetics. N.U. Lin: Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Puma; Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Pfizer; Licensing/Royalties: Up-to-date; Licensing/Royalties: Wolters Kluwer Health. R.K. Murthy: Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi Sankyo; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Puma Biotech; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Seattle Genetics; Research grant/Funding (institution): EMD Serono; Research grant/Funding (institution): Pfizer. S.A. Hurvitz: Research grant/Funding (institution): Ambryx; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Biomarin; Research grant/Funding (institution): Cascadian Therapeutics; Research grant/Funding (institution): Daiichi Sankyo; Research grant/Funding (institution): Dignitana; Research grant/Funding (institution): Genentech/Roche; Research grant/Funding (institution): GlaxoSmithKline; Research grant/Funding (institution): Immunomedics; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Macrogenics; Research grant/Funding (institution): Merrimack; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): OBI Pharma; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Pieris Pharma; Research grant/Funding (institution): Puma Biotech; Research grant/Funding (institution): Radius Health; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): SeaGen. V. Borges: Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Research grant/Funding (institution): Abbott/AbbVie; Research grant/Funding (institution): Millenium. M. Oliveira: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): PUMA Biotechnology; Advisory/Consultancy, Research grant/Funding (institution): GSK; Research grant/Funding (institution): Philips Healthcare; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Immunomedics; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Zenith; Research grant/Funding (institution): Epigenetics; Travel/Accommodation/Expenses: Pierre Fabre; Travel/Accommodation/Expenses: GP Pharma; Travel/Accommodation/Expenses: Grünenthal ; Travel/Accommodation/Expenses: Eisai. C. Lynch: Full/Part-time employment: CCRC Phoenix. K. Westbrook: Full/Part-time employment: Duke. C. Doyle: Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: BMS. M. Reinisch: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Asha; Advisory/Consultancy: Lilly; Travel/Accommodation/Expenses: Pfizer. D. Slamon: Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Lilly; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options: Pfizer; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Seattle Genetics; Travel/Accommodation/Expenses, Full/Part-time employment: Biomarin; Shareholder/Stockholder/Stock options: Amgen; Shareholder/Stockholder/Stock options: Merck Sharp & Dohme; Shareholder/Stockholder/Stock options: Vertex. G.N. Hortobagyi: Honoraria (self), Honoraria (institution), Advisory/Consultancy, Leadership role, Research grant/Funding (institution), - Protocol chair for MONALEESA2 and NATALEE, both sponsored by Novartis: Novartis; Research grant/Funding (institution): Seattle Genetics; Full/Part-time employment: MD Anderson Cancer Center, Houston TX. E.P. Winer: Honoraria (institution), Research grant/Funding (institution): Genentech/Roche; Honoraria (institution), Advisory/Consultancy: Genomic Health; Advisory/Consultancy: Carrick Therapeutics; Advisory/Consultancy: G1 Therapeutics; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy: Jounce Therapeutics; Advisory/Consultancy: Leap Therapeutics; Advisory/Consultancy: Lilly; Advisory/Consultancy: Seattle Genetics. S. McGoldrick: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Seattle Genetics; Advisory/Consultancy, Research grant/Funding (institution), spouse: AbbVie; Research grant/Funding (institution), spouse: Janssen; Research grant/Funding (institution), spouse: Takeda. X. An: Shareholder/Stockholder/Stock options, Full/Part-time employment: Seattle Genetics; Full/Part-time employment: Novartis. S. Loibl: Honoraria (self): Chugai; Honoraria (institution), Research grant/Funding (institution): AbbVie; Honoraria (institution), Research grant/Funding (institution): Amgen; Honoraria (institution), Research grant/Funding (institution): AstraZeneca; Honoraria (institution), Research grant/Funding (institution): Celgene; Honoraria (institution), Research grant/Funding (institution): Daiichi-Sankyo; Honoraria (institution), Research grant/Funding (institution): Novartis; Honoraria (institution): Lilly; Honoraria (institution), Research grant/Funding (institution): Pfizer; Honoraria (institution): Prime; Honoraria (institution): Medscape; Honoraria (institution), Research grant/Funding (institution): Roche; Honoraria (institution): Seattle Genetics; Honoraria (institution), Research grant/Funding (institution): Teva; Honoraria (institution), Research grant/Funding (institution): Vifor; Research grant/Funding (institution): Immunomedics; Licensing/Royalties, patent EP14153692.0 pending: Patent. All other authors have declared no conflicts of interest.

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