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• W4200224812 abstract "BackgroundDetection of residual disease post-NA treatment (tx) using ctDNA may indicate response and post-surg relapse risk. We profiled ctDNA and describe ctDNA dynamics in pts with NSCLC pre- and post-NA tx with atezo (anti–PD-L1) and post-surg in the LCMC3 study.MethodsPts (N=181) with stage IB to select IIIB NSCLC received 2 cycles of NA atezo before surg. Tumour tissue–informed, germline-corrected ctDNA was measured pre- and post-atezo and post-surg using the AVENIO Oncology Surveillance Test (ctDNA+ defined as ctDNA detection index ≤0.05). We correlated quantitative ctDNA levels and ctDNA presence with major pathologic response (MPR; primary endpoint), pathologic response, change in tumour size and disease-free survival (DFS).Results126 pts had sufficient tissue to test, of which 106 (84%) had tumour variants suitable for monitoring. Of these, ctDNA was detected in 72% of pre-atezo (n=101), 56% of post-atezo (n=102) and 10% of post-surg samples (n=49). Median ctDNA levels (range) dropped from 3 (0-4448) mean tumour molecules/mL plasma (mtm/mL) pre-atezo to 0.5 (0-406) mtm/mL post-atezo and 0 (0-35) mtm/mL post-surg (all paired comparisons P<0.01). Greater ctDNA reduction post-atezo was seen in pts with MPR vs non-MPR (median log2 fold change −4.8 vs 0.3, P<0.001). Reduced ctDNA levels post-atezo were also associated with pathologic response (P<0.001, r=0.38) and reduction in radiographic tumour size (P<0.001, r=0.42). 2-yr DFS rate for pts who were ctDNA– vs ctDNA+ post-surg was 75% vs 40% (HR, 3.6; 95% CI: 1.0, 13.1; P=0.054). In 64 pts with non-squamous tumours, higher disease stage was associated with higher rates of pre-atezo ctDNA+ status and ctDNA levels (all P<0.05).Conclusions>60% of pts with resectable lung cancers had sufficient tissue, trackable tumour variants, and were ctDNA+ pre-atezo. ctDNA reductions post-atezo correlated with pathologic response and reduced radiographic tumour size. 2-yr DFS was better in pts who were ctDNA– post-surg. Combining changes in ctDNA with pathologic and radiographic assessment may provide a thorough measurement of response to NA therapy, and may inform management of early NSCLC pts.Clinical trial identificationNCT02927301.Editorial acknowledgementMedical writing assistance for this abstract was provided by Derrick Afful, PhD and Christopher Lum, PhD of Health Interactions Inc, and funded by Genentech, Inc.Legal entity responsible for the studyGenentech, Inc.FundingGenentech, Inc.DisclosureM.G. Kris: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Other, Editorial Support: Genentech; Financial Interests, Personal, Other, Consultant: Novartis; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Janssen. J.M. Grindheim: Financial Interests, Personal, Full or part-time Employment: Genentech, Inc; Financial Interests, Personal, Other, Editorial/ medical writing Support: Genentech. J.E. Chaft: Financial Interests, Personal, Other, editorial/ medical writing assistance: Genentech; Financial Interests, Personal, Other, Consultant: AstraZeneca; Financial Interests, Personal, Other, Consultant: Bristol Myers Squibb; Financial Interests, Personal, Other, Consultant: Genentech; Financial Interests, Personal, Other, Consultant: Merck. J.M. Lee: Financial Interests, Personal, Other, Editorial/ medical writing Support: Novartis; Financial Interests, Personal, Other, Editorial/ medical writing Support: Genentech; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Genentech; Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Other, Consulting Fees: AstraZeneca; Financial Interests, Personal, Other, Consulting fees: Bristol Myers Squibb; Financial Interests, Personal, Other, Consulting Fees: Genentech; Financial Interests, Personal, Other, Consulting Fees: Novartis; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: Genentech; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: eCancer; Financial Interests, Personal, Speaker’s Bureau: Medscape; Financial Interests, Personal, Other, meeting attendance support: AstraZeneca; Financial Interests, Personal, Other, meeting attendance support: Genentech; Financial Interests, Personal, Leadership Role, Steering or Executive Committee for Clinical Trials: AstraZeneca; Financial Interests, Personal, Leadership Role, Steering or Executive Committee for Clinical Trials: Genentech; Financial Interests, Personal, Leadership Role, Steering or Executive Committee for Clinical Trials: Novartis. B.E. Johnson: Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Research Grant: Cannon Medical Systems; Financial Interests, Personal, Advisory Board: Hengrui Therapeutics; Financial Interests, Personal, Advisory Board: Checkpoint Therapeutics; Financial Interests, Personal, Advisory Board: Boston Pharmaceuticals; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: G1 Therapeutics; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Jazz Pharmaceuticals; Financial Interests, Personal, Advisory Board: Janssen Scientific; Financial Interests, Personal, Other, Consultant: Novartis; Financial Interests, Personal, Other, Dana-Farber Cancer Institute: Dana-Farber Cancer Institute. V.W. Rusch: Financial Interests, Institutional, Other, Institutional Clinical Trial: Genelux, Inc.; Financial Interests, Institutional, Other, Institutional clinical trial: Genentech; Financial Interests, Personal, Other, Travel reimbursement for robotic mentoring: Intuitive Surgical; Financial Interests, Personal, Other, Travel and meeting prep reimbursement for Co-Chair of Thoracic Malignancy Staging Committee: NIH/Coordinating Center for Clinical Trials. P.A. Bunn: Financial Interests, Personal, Other, editorial/ medical writing support: Genentech; Financial Interests, Personal, Other, Consulting fees: AstraZeneca; Financial Interests, Personal, Other, Consulting fees: Ascentage; Financial Interests, Personal, Other, Consulting fees: CStone; Financial Interests, Personal, Other, Consulting fees: Imidex; Financial Interests, Personal, Other, Consulting fees: Viecure; Financial Interests, Personal, Other, Consulting fees: Lilly; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Ascentage; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: CStone; Financial Interests, Personal, Advisory Board: Imidex; Financial Interests, Personal, Advisory Board: Viecure; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Leadership Role: Verastem,.H. Pass: Financial Interests, Personal, Other, Editorial/ medical writing Support: Genentech; Financial Interests, Personal, Research Grant: Delfi; Financial Interests, Personal, Research Grant: Micronoma; Financial Interests, Personal, Royalties: NCI (cell lines); Financial Interests, Personal, Speaker’s Bureau: PER; Financial Interests, Personal, Speaker’s Bureau: RTP; Financial Interests, Personal, Other, Patent: IL8 for Lung Cancer; Financial Interests, Personal, Leadership Role, Steering committee for Skyscaper: Genentech; Financial Interests, Personal, Leadership Role, Steering committee for IMpower: Genentech. E. Schum: Financial Interests, Personal, Other, Editorial/ medical writing Support: Genentech; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Genentech. J. Carlisle, M. Weyant: Financial Interests, Personal, Other, Editorial/ medical writing Support: Genentech. A. Nicholas, A. Johnson, D. Shames: Financial Interests, Personal, Other, Editorial/ medical writing Support: Genentech; Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Genentech. I. I Wistuba: Financial Interests, Personal, Other, Editorial/ medical writing Support: Genentech; Financial Interests, Personal, Research Grant: Genentech; Financial Interests, Personal, Research Grant: HTG Molecular; Financial Interests, Personal, Research Grant: DepArray; Financial Interests, Personal, Research Grant: Merck; Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Medimmune; Financial Interests, Personal, Research Grant: Adaptive; Financial Interests, Personal, Research Grant: Adaptimmune; Financial Interests, Personal, Research Grant: EMD Serono; Financial Interests, Personal, Research Grant: Pfizer; Financial Interests, Personal, Research Grant: Takeda; Financial Interests, Personal, Research Grant: Amgen; Financial Interests, Personal, Research Grant: Karus; Financial Interests, Personal, Research Grant: Johnson & Johnson; Financial Interests, Personal, Research Grant: Bayer; Financial Interests, Personal, Research Grant: Iovance; Financial Interests, Personal, Research Grant: 4D; Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Research Grant: Akoya; Financial Interests, Personal, Other, Consulting Fees: Genentech/Roche; Financial Interests, Personal, Other, Consulting fees: Bayer; Financial Interests, Personal, Other, Consulting Fees: Bristol Myers Squibb; Financial Interests, Personal, Other, Consulting Fees: AstraZeneca; Financial Interests, Personal, Other, Consulting Fees: Pfizer; Financial Interests, Personal, Other, Consulting fees: HTG Molecular; Financial Interests, Personal, Other, Consulting fees: Asuragen; Financial Interests, Personal, Other, Consulting Fees: Merck; Financial Interests, Personal, Other, Consulting fees: GlaxoSmithKline; Financial Interests, Personal, Other, Consultant Fees: Guardant Health; Financial Interests, Personal, Other, Consultant fees: Flame; Financial Interests, Personal, Other, Consultant Fees: Novartis; Financial Interests, Personal, Other, Consutant fees: Sanofi; Financial Interests, Personal, Other, Consultant Fees: Daiichi Sankyo; Financial Interests, Personal, Other, Consultant Fees: Amgen; Financial Interests, Personal, Other, Consultant fees: Oncocyte; Financial Interests, Personal, Other, Consultant fees: MSD; Financial Interests, Personal, Speaker’s Bureau: Medscape; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Genentech/Roche; Financial Interests, Personal, Speaker’s Bureau: Platform Health; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Merck. D.P. Carbone: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Other, Consultant: Bristol Myers Squibb; Financial Interests, Personal, Other, Consultant: Bristol Myers Squibb KK (Japan); Financial Interests, Personal, Other, Consultant: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Daiichi Sankyo Inc.; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: EMD Serono/Merck; Financial Interests, Personal, Advisory Board: Flame Biosciences; Financial Interests, Personal, Other, Consultant: FENIX; Financial Interests, Personal, Other, Consultant: Genentech/Roche; Financial Interests, Personal, Other, Consultant: GI Therapeutics/ Intellisphere; Financial Interests, Personal, Advisory Board: Glaxo-Smith Kline; Financial Interests, Personal, Other, Consultant: Glaxo-Smith Kline; Financial Interests, Personal, Advisory Board: Gritstone; Financial Interests, Personal, Other, Consultant: Janssen; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Other, Consultant: Mirati; Financial Interests, Personal, Other, Consultant: Novocure; Financial Interests, Personal, Other, Consultant: OncoCyte; Financial Interests, Personal, Other, Consultant: OncoHost; Financial Interests, Personal, Other, Consultant: Piper Sandler; Financial Interests, Personal, Other, Consultant: Roche China; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Seattle Genetics; Financial Interests, Personal, Other, Consultant: Seattle Genetics; Financial Interests, Personal, Other, editorial/ medical writng support: Genentech. K. Schulze: Financial Interests, Personal, Other, Editorial/ medical writing Support: Genentech; Financial Interests, Personal, Full or part-time Employment: Genentech; Financial Interests, Personal, Stocks/Shares: Genentech. D.J. Kwiatkowski: Financial Interests, Personal, Other, Editorial/ medical writing Support: Genentech. BackgroundDetection of residual disease post-NA treatment (tx) using ctDNA may indicate response and post-surg relapse risk. We profiled ctDNA and describe ctDNA dynamics in pts with NSCLC pre- and post-NA tx with atezo (anti–PD-L1) and post-surg in the LCMC3 study. Detection of residual disease post-NA treatment (tx) using ctDNA may indicate response and post-surg relapse risk. We profiled ctDNA and describe ctDNA dynamics in pts with NSCLC pre- and post-NA tx with atezo (anti–PD-L1) and post-surg in the LCMC3 study. MethodsPts (N=181) with stage IB to select IIIB NSCLC received 2 cycles of NA atezo before surg. Tumour tissue–informed, germline-corrected ctDNA was measured pre- and post-atezo and post-surg using the AVENIO Oncology Surveillance Test (ctDNA+ defined as ctDNA detection index ≤0.05). We correlated quantitative ctDNA levels and ctDNA presence with major pathologic response (MPR; primary endpoint), pathologic response, change in tumour size and disease-free survival (DFS). Pts (N=181) with stage IB to select IIIB NSCLC received 2 cycles of NA atezo before surg. Tumour tissue–informed, germline-corrected ctDNA was measured pre- and post-atezo and post-surg using the AVENIO Oncology Surveillance Test (ctDNA+ defined as ctDNA detection index ≤0.05). We correlated quantitative ctDNA levels and ctDNA presence with major pathologic response (MPR; primary endpoint), pathologic response, change in tumour size and disease-free survival (DFS). Results126 pts had sufficient tissue to test, of which 106 (84%) had tumour variants suitable for monitoring. Of these, ctDNA was detected in 72% of pre-atezo (n=101), 56% of post-atezo (n=102) and 10% of post-surg samples (n=49). Median ctDNA levels (range) dropped from 3 (0-4448) mean tumour molecules/mL plasma (mtm/mL) pre-atezo to 0.5 (0-406) mtm/mL post-atezo and 0 (0-35) mtm/mL post-surg (all paired comparisons P<0.01). Greater ctDNA reduction post-atezo was seen in pts with MPR vs non-MPR (median log2 fold change −4.8 vs 0.3, P<0.001). Reduced ctDNA levels post-atezo were also associated with pathologic response (P<0.001, r=0.38) and reduction in radiographic tumour size (P<0.001, r=0.42). 2-yr DFS rate for pts who were ctDNA– vs ctDNA+ post-surg was 75% vs 40% (HR, 3.6; 95% CI: 1.0, 13.1; P=0.054). In 64 pts with non-squamous tumours, higher disease stage was associated with higher rates of pre-atezo ctDNA+ status and ctDNA levels (all P<0.05). 126 pts had sufficient tissue to test, of which 106 (84%) had tumour variants suitable for monitoring. Of these, ctDNA was detected in 72% of pre-atezo (n=101), 56% of post-atezo (n=102) and 10% of post-surg samples (n=49). Median ctDNA levels (range) dropped from 3 (0-4448) mean tumour molecules/mL plasma (mtm/mL) pre-atezo to 0.5 (0-406) mtm/mL post-atezo and 0 (0-35) mtm/mL post-surg (all paired comparisons P<0.01). Greater ctDNA reduction post-atezo was seen in pts with MPR vs non-MPR (median log2 fold change −4.8 vs 0.3, P<0.001). Reduced ctDNA levels post-atezo were also associated with pathologic response (P<0.001, r=0.38) and reduction in radiographic tumour size (P<0.001, r=0.42). 2-yr DFS rate for pts who were ctDNA– vs ctDNA+ post-surg was 75% vs 40% (HR, 3.6; 95% CI: 1.0, 13.1; P=0.054). In 64 pts with non-squamous tumours, higher disease stage was associated with higher rates of pre-atezo ctDNA+ status and ctDNA levels (all P<0.05). Conclusions>60% of pts with resectable lung cancers had sufficient tissue, trackable tumour variants, and were ctDNA+ pre-atezo. ctDNA reductions post-atezo correlated with pathologic response and reduced radiographic tumour size. 2-yr DFS was better in pts who were ctDNA– post-surg. Combining changes in ctDNA with pathologic and radiographic assessment may provide a thorough measurement of response to NA therapy, and may inform management of early NSCLC pts. >60% of pts with resectable lung cancers had sufficient tissue, trackable tumour variants, and were ctDNA+ pre-atezo. ctDNA reductions post-atezo correlated with pathologic response and reduced radiographic tumour size. 2-yr DFS was better in pts who were ctDNA– post-surg. Combining changes in ctDNA with pathologic and radiographic assessment may provide a thorough measurement of response to NA therapy, and may inform management of early NSCLC pts." @default.
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• W4200224812 title "1O Dynamic circulating tumour DNA (ctDNA) response to neoadjuvant (NA) atezolizumab (atezo) and surgery (surg) and association with outcomes in patients (pts) with NSCLC" @default.
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