For cancer clinical trials that require central confirmation of tumor genomic profiling, exhaustion of tissue from standard-of-care testing may prevent enrollment. For Lung-MAP, a master protocol that requires results from a defined centralized clinical trial assay to assign patients to a therapeutic substudy, we developed a process to repurpose existing commercial vendor raw genomic data for eligibility: genomic data reanalysis (GDR). Molecular results for substudy assignment were successfully generated for 369 of the first 374 patients (98.7%) using GDR for Lung-MAP, with a median time from request to result of 9 days. During the same period, 691 of 791 (87.4%) tissue samples received successfully yielded results, in a median of 14 days beyond sample acquisition. GDR is a scalable bioinformatic pipeline that expedites reanalysis of existing data for clinical trials in which validated integral biomarker testing is required for participation.

J.W.N.: Honoraria: CME Matters, Clinical Care Options CME, Research to Practice CME, Medscape CME, Biomedical Learning Institute CME, MLI Peerview CME, Prime Oncology CME, Projects in Knowledge CME, Rockpointe CME, MJH Life Sciences CME, Medical Educator Consortium, HMP Education. Consulting or Advisory Role: AstraZeneca, Genentech/Roche, Exelixis, Takeda Pharmaceuticals, Eli Lilly and Company, Amgen, Iovance Biotherapeutics, Blueprint Pharmaceuticals, Regeneron Pharmaceuticals, Natera, Sanofi/Regeneron, D2G Oncology, Surface Oncology, Turning Point Therapeutics, Mirati Therapeutics, Gilead Sciences, AbbVie, Summit Therapeutics, Novartis, Novocure, Janssen Oncology, Anheart Therapeutics. Research Funding: Genentech/Roche (Inst), Merck (Inst), Novartis (Inst), Boehringer Ingelheim (Inst), Exelixis (Inst), Nektar Therapeutics (Inst), Takeda Pharmaceuticals (Inst), Adaptimmune (Inst), GSK (Inst), Janssen (Inst), AbbVie (Inst), Novocure (Inst). R.B., R.S.P.H., M.C.H., C.A., L.W.P. are full-time employees of Foundation Medicine, Inc. and hold stock in Roche Holdings AG. J.P.: consulting or advisory: AstraZeneca, AbbVie, AnHeart, BMS, Gilead, Guardant, Takeda, Genentech, Blueprint, Genentech/Roche, Eli Lilly, Regeneron. R.H.: Board of directors for Immunocore, Junshi Pharmaceuticals; consultant for AbbVie Pharmaceuticals, AstraZeneca, Bolt Biotherapeutics, Bristol-Myers Squibb, Candel Therapeutics, Checkpoint Therapeutics, Cybrexa Therapeutics, DynamiCure Biotechnology, eFFECTOR Therapeutics, Eli Lilly and Company, EMD Serono, Genentech, Gilead, HiberCell, I-Mab Biopharma, Immune-Onc Therapeutics, Immunocore, Janssen, Johnson and Johnson, Loxo Oncology, Merck and Company, Mirati Therapeutics, NextCure, Normunity, Novartis, Ocean Biomedical, Oncocyte Corp, Oncternal Therapeutics, Pfizer, Regeneron Pharmaceuticals, Revelar Biotherapeutics, Ribbon Therapeutics, Roche, Sanofi, Seattle Genetics, Xencor; research support from AstraZeneca, Eli Lilly and Company, Genentech/Roche, Merck and Company; leadership role in American Association for Cancer Research, International Association for the Study of Lung Cancer, Society for Immunotherapy of Cancer, Southwest Oncology Group. K.L.R.: Consultant with honoraria to self: Amgen, AstraZeneca, Blueprint, Daiichi Sankyo, EMD Serono, Genentech, GlaxoSmithKline, Janssen, Lilly, Novocure, Mirati. Research funding to institution: Genentech; Blueprint; Calithera; Daiichi Sankyo; Elevation Oncology; Janssen. H.B.: Research Support (Clinical Trials): BMS, Lilly, Amgen; Advisory Board/Consultant: BMS, Lilly, Genentech, Pfizer, Merck, EMD Serono, Boehringer Ingelheim, Astra Zeneca, Novartis, Genmab, Regeneron, BioNTech, Amgen, Axiom, PharmaMar, Takeda, Mirati, Daiichi, Guardant, Natera, Oncocyte, Beigene, iTEO, Jazz, Janssen, Puma, BerGenBio, Bayer, Iobiotech, Grid Therapeutics; Data and Safety Monitoring Board: University of Pennsylvania: CAR T Program, Takeda, Incyte, Novartis, Springworks; Employment:Fox Chase Cancer Center; Scientific Advisory Board: Sonnetbio (Stock Options); Inspirna (formerly Rgenix, Stock Options); Nucleai (stock options); Honoraria: Amgen, Pfizer, Daiichi, Regeneron; Travel: Amgen, BMS, Merck, Lilly, EMD Serono, Genentech, Regeneron, Mirati. D.E.K. Honoraria: RefleXion. Consulting or advisory role: Genentech. K.M., L.H., and M.W.R. indicated no financial relationships.