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Ibrutinib combination therapy for advanced gastrointestinal and genitourinary tumours: results from a phase 1b/2 study.
Oh, Do-Youn; Maqueda, Maria Alsina; Quinn, David I; O'Dwyer, Peter J; Chau, Ian; Kim, Sun Young; Duran, Ignacio; Castellano, Daniel; Berlin, Jordan; Mellado, Begona; Williamson, Stephen K; Lee, Keun-Wook; Marti, Francisca; Mathew, Paul; Saif, Muhammad Wasif; Wang, Ding; Chong, Elizabeth; Hilger-Rolfe, Jacqueline; Dean, James P; Arkenau, Hendrik-Tobias.
Affiliation
  • Oh DY; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University Graduate School, Seoul, South Korea. ohdoyoun@snu.ac.kr.
  • Maqueda MA; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
  • Quinn DI; University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
  • O'Dwyer PJ; University of Pennsylvania, Philadelphia, PA, USA.
  • Chau I; The Royal Marsden NHS Foundation Trust-Royal Marsden Hospital, London, UK.
  • Kim SY; Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
  • Duran I; Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.
  • Castellano D; Hospital Universitario, 12 de Octubre, Madrid, Spain.
  • Berlin J; Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
  • Mellado B; Medical Oncology Department, Hospital Clinic i Provincial de Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain.
  • Williamson SK; University of Kansas Hospital Cancer Center, Kansas City, KS, USA.
  • Lee KW; Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
  • Marti F; The Christie NHS Foundation Trust, Manchester, UK.
  • Mathew P; Tufts Medical Center, Boston, MA, USA.
  • Saif MW; Tufts Medical Center, Boston, MA, USA.
  • Wang D; Orlando Health Cancer Institute, Orlando, FL, USA.
  • Chong E; Henry Ford Hospital, Detroit, MI, USA.
  • Hilger-Rolfe J; Pharmacyclics LLC, an AbbVie Company, South San Francisco, CA, USA.
  • Dean JP; Pharmacyclics LLC, an AbbVie Company, South San Francisco, CA, USA.
  • Arkenau HT; Pharmacyclics LLC, an AbbVie Company, South San Francisco, CA, USA.
BMC Cancer ; 23(1): 1056, 2023 Nov 03.
Article in En | MEDLINE | ID: mdl-37919668
BACKGROUND: Ibrutinib, a first-in-class inhibitor of Bruton's tyrosine kinase, is approved for the treatment of various B-cell malignancies and chronic graft-versus-host disease. Based on encouraging preclinical data, safety and efficacy of ibrutinib combined with companion drugs for advanced renal cell carcinoma (RCC), gastric/gastroesophageal junctional adenocarcinoma (GC), and colorectal adenocarcinoma (CRC) were evaluated. METHODS: Ibrutinib 560 mg or 840 mg once daily was administered with standard doses of everolimus for RCC, docetaxel for GC, and cetuximab for CRC. Endpoints included determination of the recommended phase 2 dose (RP2D) of ibrutinib in phase 1b and efficacy (overall response rate [ORR] for GC and CRC; progression-free survival [PFS] for CRC) in phase 2. RESULTS: A total of 39 (RCC), 46 (GC), and 50 (RCC) patients were enrolled and received the RP2D. Safety profiles were consistent with the individual agents used in the study. Confirmed ORRs were 3% (RCC), 21% (GC), and 19% (CRC). Median (90% CI) PFS was 5.6 (3.9-7.5) months in RCC, 4.0 (2.7-4.2) months in GC, and 5.4 (4.1-5.8) months in CRC. CONCLUSIONS: Clinically meaningful increases in efficacy were not observed compared to historical controls; however, the data may warrant further evaluation of ibrutinib combinations in other solid tumours. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02599324.
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Full text: 1 Database: MEDLINE Main subject: Carcinoma, Renal Cell / Kidney Neoplasms Limits: Humans Language: En Journal: BMC Cancer Journal subject: NEOPLASIAS Year: 2023 Type: Article Affiliation country: Korea (South)

Full text: 1 Database: MEDLINE Main subject: Carcinoma, Renal Cell / Kidney Neoplasms Limits: Humans Language: En Journal: BMC Cancer Journal subject: NEOPLASIAS Year: 2023 Type: Article Affiliation country: Korea (South)