Abstract 1307P
Background
BFAST (NCT03178552) is an ongoing global study evaluating the relationship between blood-based next-generation sequencing (NGS) detection of actionable genetic alterations in circulating tumour DNA and activity of targeted therapies and immunotherapy in pts with 1L aNSCLC. The natural history Cohort Z is non-interventional and collects RWD for pts not receiving treatment as part of the trial. We present BFAST screened pts’ characteristics and prevalence of genomic alterations detected in blood.
Methods
BFAST pts were screened using Foundation Medicine, Inc. (FMI)’s liquid biopsy assay (FoundationACT). Demographics and genomic alteration prevalence of 5847 BFAST screened pts (as of 31 Dec 2019) were compared with a concurrent cohort of 3784 aNSCLC pts from the de-identified Flatiron Health-FMI Clinico-Genomic Database (CGDB) of FMI-tested US pts who were treated in the Flatiron Health network. ∼80% of these pts were tissue-tested, including 1293 “BFAST-like” pts who were tested before 1L treatment and were ECOG PS 0–2 at testing.
Results
The prevalence of genomic alterations was similar in BFAST-screened and concurrent CGDB pts, with the exception of KRAS and PIK3CA alterations, which were higher in CGDB pts (Table). BFAST pts were younger (median age 66 vs 70 yrs) with a higher proportion of Asian (20 vs 4%), male (59 vs 50%) and ECOG PS 0–1 pts (91 vs 67%), and fewer smokers (69 vs 83%).
Conclusions
To our knowledge, BFAST is the first blood-based NGS genomic survey of a large cohort of 1L aNSCLC pts in a global clinical trial setting. The prevalence of genomic alterations was generally similar to CGDB, despite the use of blood assays vs predominantly tissue assays. Future comparisons of BFAST Cohort Z, CGDB tissue- and blood-tested pts, and their clinical outcome, will provide insights into the value of blood-based NGS testing in global trial and community settings Table: 1307P
| Prevalence of select genomic alterations, n (%) | BFAST screened (n=5847) | BFAST-like CGDB* (n=1293) | CGDB (n=3784) |
| EGFR+ | 889 (15) | 186 (14) | 624 (16) |
| L858R | 258 (4) | 52 (4) | 178 (5) |
| Exon 19 deletion | 364 (6) | 64 (5) | 240 (6) |
| Exon 20 insertion | 81 (1) | 13 (1) | 37 (1) |
| KRAS+ | 1211 (21) | 419 (32) | 1069 (28) |
| G12C | 428 (7) | 163 (13) | 375 (10) |
| ALK fusion | 194 (3) | 21 (2) | 94 (2) |
| ROS1 fusion | 47 (0.8) | 6 (0.5) | 23 (0.6) |
| RET fusion | 71 (1) | 7 (0.5) | 29 (0.8) |
| BRAF V600 | 62 (1) | 23 (2) | 61 (2) |
| MET exon 14 skipping | 86 (1) | 21 (2) | 64 (2) |
| PIK3CA+ | 334 (6) | 120 (9) | 365 (10) |
*ECOG PS 0–2, tested before 1L treatment.
.Clinical trial identification
NCT03178552.
Editorial acknowledgement
Editorial support was provided by Fiona Duthie, PhD, of Gardiner-Caldwell Communications and was funded by F. Hoffmann-La Roche Ltd.
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
R. Dziadziuszko: Honoraria (self), Advisory/Consultancy: F. Hoffmann La-Roche Ltd, FoundationMedicine, Pfizer, Boehringer Ingelheim, Novartis, AstraZeneca, Seattle Genetics, MSD and Takeda. Q. Zhang: Full/Part-time employment: F. Hoffmann La-Roche Ltd/Genentech, Inc; Shareholder/Stockholder/Stock options: F. Hoffmann-La Roche Ltd, Regeneron, Bristol-Myers Squibb and AbbVie. X. Li, S. Mocci, D.S. Shames, M.S. Mathisen: Full/Part-time employment: Genentech, Inc. S.M. Paul: Full/Part-time employment: Genentech, Inc; Shareholder/Stockholder/Stock options: F. Hoffmann-La Roche Ltd. M. Sugidono: Full/Part-time employment: Genentech, Inc. and the University of California. A. Kinkolykh: Advisory/Consultancy: F. Hoffmann-La Roche Ltd. V. Archer: Full/Part-time employment: Roche Products Ltd. D.X. Jin: Full/Part-time employment: Foundation Medicine, Inc.; Shareholder/Stockholder/Stock options: F Hoffman-La Roche Ltd. S.M. Gadgeel: Honoraria (self), Advisory/Consultancy: F. Hoffmann La-Roche Ltd/Genentech, AstraZeneca, Bristol-Myers Squibb, Novartis, Daiichi Sankyo, Boehringer Ingelheim and XCovery. S. Peters: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AbbVie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche Ltd, Foundation Medicine, Illumina, Janssen, Merck Sharp & Dohme, Merck Serono, Merrimack, Novart. T. Mok: Leadership role: Sanonics Ltd; Honoraria (self), Advisory/Consultancy: ACEA Biosciences, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Chimed, Cirina, Fishawack Facilitate, Ignyta, Janssen, Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, OncoGenex, Pfizer, F. Hoffmann La-Roche Ltd/Genentech, SFJ Pharm; Research grant/Funding (self): AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, Merck Sharp & Dohme, Novartis, Pfizer, F. Hoffmann La-Roche Ltd, SFJ Pharmaceutical and XCovery.