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Poster Display session 2

4119 - CONTESSA TRIO: A Multinational, Multicenter, Phase 2 Study of Tesetaxel plus 3 Different PD-(L)1 Inhibitors in Patients with Metastatic Triple-Negative Breast Cancer (TNBC) and Tesetaxel Monotherapy in Elderly Patients with HER2- Metastatic Breast Cancer (MBC)

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Breast Cancer

Presenters

Sara Tolaney

Citation

Annals of Oncology (2019) 30 (suppl_5): v104-v142. 10.1093/annonc/mdz242

Authors

S.M. Tolaney1, J.L. Blum2, I. Bondarenko3, A. Chan4, N. DaCosta5, Y. Feng6, Y. Izarzugaza7, S. Kim8, M. Liu9, M. Oliveira10, S.G.W. Ow11, M. Pavic12, M.E. Peréz Lopéz13, H.S. Rugo14, L. Schwartzberg15, A. Stradella16, S. Kroll17, J. O'Connell18, T. Wei17, E.A. Mittendorf19

Author affiliations

  • 1 Medical Oncology, Dana Farber Cancer Institute, 02215 - Boston/US
  • 2 Medical Oncology, Texas Oncology - Baylor Sammons Cancer Center, 75246 - Dallas/US
  • 3 Oncology And Medical Radiology Department, City Clinical Hospital №4, 49000 - Dnipro/UA
  • 4 Oncology, Breast Cancer Research Centre BCRC - WA, 6009 - Nedlands/AU
  • 5 Oncology, North Shore Hematology Oncology Associates, 11733 - East Setauket/US
  • 6 Hematology And Medical Oncology, Chi Mei Medical Center, 710 - Tainan/TW
  • 7 Medical Oncology, Hospital Universitario Fundación Jiménez Díaz, 28040 - Madrid/ES
  • 8 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 05505 - Seoul/KR
  • 9 Hematology And Medical Oncology, Koo Foundation Sun Yat-Sen Cancer Center, 11259 - Taipei/TW
  • 10 Department Of Medical Oncology, Vall d’Hebron University Hospital, 08035 - Barcelona/ES
  • 11 Haematology-oncology, National University Cancer Institute, Singapore, 119228 - Singapore/SG
  • 12 Hemato-oncology, Centre hospitalier universitaire de Sherbrooke, J1H 5N4 - Sherbrooke/CA
  • 13 Oncology, A Coruña Universitary Hospital, 15006 - La Coruña/ES
  • 14 Medicine, University of California San Francisco Comprehensive Cancer Center, 94115 - San Francisco/US
  • 15 Oncology, West Cancer Center, 38138 - Germantown/US
  • 16 Medical Oncology, Institut Català d’Oncologia, 08908 - Barcelona/ES
  • 17 Research And Development, Odonate Therapeutics, Inc., 92121 - San Diego/US
  • 18 Medical And Clinical Affairs, Odonate Therapeutics, Inc., 92121 - San Diego/US
  • 19 Surgical Oncology, Brigham and Women´s Hospital, 02115 - Boston/US

Resources

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Abstract 4119

Background

Chemotherapy (CT) treatments with robust efficacy that preserve quality of life are needed. Tesetaxel (T) is a novel, oral taxane that has potential advantages over currently available taxanes, including: oral administration with a low pill burden and once every 3 week (Q3W) dosing; no observed hypersensitivity reactions; and preclinical evidence of central nervous system (CNS) penetration and improved activity against CT-resistant tumors. More than 600 pts have been treated with T in clinical studies. T had robust monotherapy activity in a phase 2 study in 38 pts with HER2-, HR+ MBC, with a confirmed objective response rate (ORR) per RECIST 1.1 of 45%.

Trial design

CONTESSA TRIO is a 2-cohort, multinational, multicenter, Phase 2 study. In Cohort 1, 90 pts (with potential expansion to up to 150 pts) with metastatic TNBC who have not received prior CT for advanced disease will be randomized 1:1:1 to receive T at 27 mg/m2 Q3W plus either: (1) nivolumab at 360 mg Q3W; (2) pembrolizumab at 200 mg Q3W; or (3) atezolizumab at 1,200 mg Q3W. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are approved for the treatment of multiple types of cancer; atezolizumab, in combination with nab-paclitaxel, was recently approved in the U.S. for the treatment of metastatic TNBC. The dual primary endpoints for Cohort 1 are ORR and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the 3 PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the 3 approved PD-L1 diagnostic assays. CONTESSA TRIO is the first randomized clinical study to compare 3 approved PD-(L)1 inhibitors. In Cohort 2, 40 elderly pts (with potential expansion to up to 60 pts) with HER2- MBC who have not received prior CT for advanced disease will receive T monotherapy at 27 mg/m2 Q3W. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Pts with CNS metastases are eligible for both cohorts. The Study was initiated in March 2019.

Clinical trial identification

EudraCT: 2018-004715-41.

Editorial acknowledgement

Legal entity responsible for the study

Odonate Therapeutics, Inc.

Funding

Odonate Therapeutics, Inc.

Disclosure

S.M. Tolaney: Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Genentech; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Merck; Research grant / Funding (institution): Exelixis; Advisory / Consultancy, Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Cyclacel; Advisory / Consultancy, Research grant / Funding (institution): Immunomedics; Research grant / Funding (institution): Odonate Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Nektar Therapeutics; Advisory / Consultancy: Tesaro; Advisory / Consultancy: NanoString Technologies; Advisory / Consultancy: Puma Biotechnology. J.L. Blum: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Medivation; Advisory / Consultancy: Novartis; Research grant / Funding (institution): Bristol-Myers Squibb. A. Chan: Research grant / Funding (institution): Eisai; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Puma Biotechnology; Speaker Bureau / Expert testimony: Prime Oncology; Travel / Accommodation / Expenses: Pierre Fabre. Y. Feng: Research grant / Funding (institution), Full / Part-time employment: Chi Mei Medical Center. S. Kim: Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Sanofi-Genzyme; Research grant / Funding (institution): DongKook Pharmaceutical. M. Liu: Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca. M. Oliveira: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Research grant / Funding (institution): GSK; Advisory / Consultancy, Research grant / Funding (institution): Puma Biotechnology; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Philips Healthcare; Research grant / Funding (institution): Genentech; Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution): Immunomedics; Research grant / Funding (institution): Seattle Genetics; Research grant / Funding (institution): Boehringer-Ingelheim; Travel / Accommodation / Expenses: Pierre-Fabre; Travel / Accommodation / Expenses: GP Pharma; Travel / Accommodation / Expenses: Grünenthal. M. Pavic: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Celgene; Honoraria (self): Janssen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Takeda; Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy: Roche; Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Astellas Pharma; Travel / Accommodation / Expenses: Taiho Pharmaceutical; Travel / Accommodation / Expenses: Bayer. H.S. Rugo: Research grant / Funding (institution), Travel / Accommodation / Expenses, Mandatory publication support: Roche/Genentech; Research grant / Funding (institution), Travel / Accommodation / Expenses, Mandatory publication support: Pfizer; Travel / Accommodation / Expenses: Puma Biotechnology; Travel / Accommodation / Expenses: Mylan; Travel / Accommodation / Expenses: Daiichi Sankyo; Research grant / Funding (institution), Travel / Accommodation / Expenses: MacroGenics; Honoraria (self): Celltrion; Research grant / Funding (institution): OBI Pharma; Research grant / Funding (institution): Eisai; Research grant / Funding (institution), Mandatory publication support: Novartis; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Immunomedics; Research grant / Funding (institution): Odonate Therapeutics; Research grant / Funding (institution), Travel / Accommodation / Expenses, Mandatory publication support: Roche/Genentech; Research grant / Funding (institution), Travel / Accommodation / Expenses, Mandatory publication support: Pfizer; Travel / Accommodation / Expenses: Puma Biotechnology; Travel / Accommodation / Expenses: Mylan; Travel / Accommodation / Expenses: Daiichi Sankyo; Research grant / Funding (institution), Travel / Accommodation / Expenses: MacroGenics; Honoraria (self): Celltrion; Research grant / Funding (institution): OBI Pharma; Research grant / Funding (institution): Eisai; Research grant / Funding (institution), Mandatory publication support: Novartis; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Immunomedics; Research grant / Funding (institution): Odonate Therapeutics. L. Schwartzberg: Advisory / Consultancy, Research grant / Funding (institution): Helsinn; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Merck; Advisory / Consultancy: Heron Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Amgen; Speaker Bureau / Expert testimony: Coherus BioSciences; Speaker Bureau / Expert testimony: Puma Biotechnology. A. Stradella: Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Celgene. S. Kroll: Shareholder / Stockholder / Stock options, Full / Part-time employment: Odonate Therapeutics. J. O’Connell: Leadership role, Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment, Officer / Board of Directors: Odonate Therapeutics; Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: inVentiv Health. T. Wei: Shareholder / Stockholder / Stock options, Full / Part-time employment: Odonate Therapeutics. E.A. Mittendorf: Advisory / Consultancy: Amgen; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Genentech; Advisory / Consultancy: Genomic Health; Advisory / Consultancy: Merck; Advisory / Consultancy: Peregrine Pharmaceuticals; Advisory / Consultancy, Research grant / Funding (institution): Sellas Lifesciences; Advisory / Consultancy: Tapimmune. All other authors have declared no conflicts of interest.

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