Your browser doesn't support javascript.
loading
Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-expansion stage of a multicentre, open-label, phase I trial.
Friedlander, Michael; Mileshkin, Linda; Lombard, Janine; Frentzas, Sophia; Gao, Bo; Wilson, Michelle; Meniawy, Tarek; Baron-Hay, Sally; Briscoe, Karen; McCarthy, Nicole; Fountzilas, Christos; Cervantes, Andres; Ge, Ruimin; Wu, John; Spira, Alexander.
Afiliação
  • Friedlander M; University of New South Wales Clinical School and Department of Medical Oncology, Prince of Wales Hospital, Randwick, NSW, Australia. michael.friedlander@health.nsw.gov.au.
  • Mileshkin L; Department of Medical Oncology, Peter MacCallum Cancer Centre, and the Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Parkville, VIC, Australia.
  • Lombard J; Medical Oncology, Calvary Mater Newcastle, NSW, Australia.
  • Frentzas S; Department of Medical Oncology, Monash Health and Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.
  • Gao B; Medical Oncology Department, Blacktown Hospital, Sydney, NSW, Australia.
  • Wilson M; Department of Cancer and Blood, Auckland City Hospital, Auckland, New Zealand.
  • Meniawy T; Department of Medical Oncology, Linear Clinical Research and University of Western Australia, Nedlands, WA, Australia.
  • Baron-Hay S; Department of Medical Oncology, Royal North Shore Hospital, St Leonards, NSW, Australia.
  • Briscoe K; GenesisCare, Melbourne, VIC, Australia.
  • McCarthy N; Department of Medical Oncology, Mid North Coast Cancer Institute, Coffs Harbour, NSW, Australia.
  • Fountzilas C; Department of Medical Oncology, Icon Cancer Centre Wesley, Auchenflower, QLD, Australia.
  • Cervantes A; Department of Medicine/Division of GI Medicine and Early Phase Clinical Trial Program, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
  • Ge R; Department of Medical Oncology, Hospital Clínico Universitario, INCLIVA Biomedical Research Institute, University of Valencia, Valencia, Spain.
  • Wu J; Instituto de Salud Carlos III, CIBERONC, Madrid, Spain.
  • Spira A; Department of Clinical Development, BeiGene (Beijing) Co., Ltd., Beijing, China.
Br J Cancer ; 129(5): 797-810, 2023 09.
Article em En | MEDLINE | ID: mdl-37474720
BACKGROUND: The aim of this study was to investigate the antitumour activity, safety, and tolerability of pamiparib plus tislelizumab in patients with previously treated advanced solid tumours. METHODS: In this study, patients were enrolled into eight arms by tumour type. All received pamiparib 40 mg orally twice daily plus tislelizumab 200 mg intravenously every 3 weeks. The primary endpoint was objective response rate (ORR), assessed by the investigator per Response Evaluation Criteria in Solid Tumours v1.1. Secondary endpoints included duration of response (DoR), safety, and tolerability. RESULTS: Overall, 180 patients were enrolled. In the overall population, the ORR was 20.0% (range: 0-47.4 across study arms), with median DoR of 17.1 months (95% confidence interval [CI]: 6.2, not estimable [NE]). The highest ORR was observed in the triple-negative breast cancer (TNBC) arm (patients with BRCA1/2 mutations and/or homologous recombination deficiency) (ORR: 47.4%; median DoR: 17.1 months [95% CI: 3.0, NE]). Treatment-emergent adverse events (TEAEs) of ≥Grade 3 occurred in 61.7% of patients. Serious TEAEs occurred in 50.0% of patients. CONCLUSIONS: Pamiparib plus tislelizumab showed a variable level of antitumour activity in patients with advanced solid tumours, with the highest ORR in TNBC and was associated with a manageable safety profile. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov: NCT02660034.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Proteína BRCA1 / Neoplasias de Mama Triplo Negativas Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Proteína BRCA1 / Neoplasias de Mama Triplo Negativas Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article