Alexandre Vivot1,2, Jacques Li1,2, Jean-David Zeitoun1,2, Samia Mourah3,4, Perrine Crequit1,2, Philippe Ravaud1,2,5,6, Raphaël Porcher1,2,5. 1. Assistance Publique des Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Centre d'Épidémiologie Clinique, Paris, France. 2. INSERM, UMR1153 Epidemiology and Biostatistics Sorbonne Paris Cité Research Center (CRESS), METHODS Team, Paris Descartes University, Paris, France. 3. Department of Pharmacology-Genetics, Assistance Publique des Hôpitaux de Paris (AP-HP), Saint-Louis Hospital, Paris, France. 4. INSERM UMRS 976, Paris, France. 5. Faculté de Médecine, Université Paris Descartes, Paris, France. 6. Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA.
Abstract
PURPOSE: The aim of this study was to describe pharmacogenomics-based inclusion criteria (enrichment) and the main characteristics of clinical trials involving oncology-targeted therapies. METHODS: Clinical trials of oncology-targeted therapies approved after 2005 with pharmacogenomic testing required or recommended in their label were retrieved from a mapping of the ClinicalTrials.gov database. RESULTS: We examined information for 12 drugs and 858 trials. Overall, 434 trials (51%) were enriched on the biomarker first mentioned in the label and 145 (17%) were enriched on another biomarker, whereas 270 trials (31%) included all patients. The median proportion of trials corresponding to both the drug's indication and drug's target was 35%. Of the 361 trials that tested drugs in another disease than the first one in the label, 219 (61%) were without enrichment and 87 (24%) were actually enriched but on another biomarker than the first one in the label. CONCLUSION: Several drugs have been tested in trials enriched on many different biomarkers. Nonetheless, most targeted therapies have been developed only using biomarker-positive patients; therefore, exclusion of biomarker-negative patients from treatment relies on only preclinical data and on biological understanding of the disease and target.Genet Med 18 8, 796-805.
PURPOSE: The aim of this study was to describe pharmacogenomics-based inclusion criteria (enrichment) and the main characteristics of clinical trials involving oncology-targeted therapies. METHODS: Clinical trials of oncology-targeted therapies approved after 2005 with pharmacogenomic testing required or recommended in their label were retrieved from a mapping of the ClinicalTrials.gov database. RESULTS: We examined information for 12 drugs and 858 trials. Overall, 434 trials (51%) were enriched on the biomarker first mentioned in the label and 145 (17%) were enriched on another biomarker, whereas 270 trials (31%) included all patients. The median proportion of trials corresponding to both the drug's indication and drug's target was 35%. Of the 361 trials that tested drugs in another disease than the first one in the label, 219 (61%) were without enrichment and 87 (24%) were actually enriched but on another biomarker than the first one in the label. CONCLUSION: Several drugs have been tested in trials enriched on many different biomarkers. Nonetheless, most targeted therapies have been developed only using biomarker-positive patients; therefore, exclusion of biomarker-negative patients from treatment relies on only preclinical data and on biological understanding of the disease and target.Genet Med 18 8, 796-805.
Authors: Rafael G Amado; Michael Wolf; Marc Peeters; Eric Van Cutsem; Salvatore Siena; Daniel J Freeman; Todd Juan; Robert Sikorski; Sid Suggs; Robert Radinsky; Scott D Patterson; David D Chang Journal: J Clin Oncol Date: 2008-03-03 Impact factor: 44.544
Authors: Cecilia Superchi; Florie Brion Bouvier; Chiara Gerardi; Montserrat Carmona; Lorena San Miguel; Luis María Sánchez-Gómez; Iñaki Imaz-Iglesia; Paula Garcia; Jacques Demotes; Rita Banzi; Raphaël Porcher Journal: BMJ Open Date: 2022-05-06 Impact factor: 3.006