Molecular testing in patients with advanced NSCLC from 2016-23 (Prospective German Registry CRISP, AIO-TRK-0315)

BackgroundIn the last decade, new therapies for NSCLC patients (pts) with specific molecular alterations have emerged. Guidelines now mandate testing pts for these targets. Understanding diagnostics in routine practice is crucial to enhance quality of care.MethodsThe prospective, national clinical research platform CRISP recruits pts in representative cancer centres in all therapeutic sectors in Germany since 2016. More than 10.000 pts were recruited and followed for up to 5 years. Data on molecular testing until 2018 from 2.200 pts was presented at ESMO 2018. We present an update with data cut Q3/2023, including data from 8.936 pts recruited by 181 sites.ResultsSince 2022, 99% of nsq pts, and 97% of sq pts were tested with at least one test method at start of first-line. The respective test rates before 2020 (2020-TR) were 95% (nsq) and 78% (sq). In 2023 78% (nsq) and 62% (sq) of pts were tested by NGS (vs. 46% / 17% before 2020). Test rates for nsq pts in 2022 (vs. 2020-TR) for EGFR, ALK, ROS1, and BRAF were 83% (80%), 84% (78%), 84% (71%), and 81% (61%), respectively. Test rates for sq pts in 2022 (vs. 2020-TR) for EGFR, ALK, ROS1, and BRAF were 57% (30%), 58% (27%), 57% (23%), and 54% (23%), respectively. Test rates for PD-L1 increased to 86% in 2022/23 from 70% (nsq), and 67% (sq) before 2020. Current test rates for new clinical relevant markers (vs. 2020-TR) for nsq pts were 74% (31%) for RET, 77% (41%) for C-MET, and 77% (50%) for KRAS. Respective test rates for sq pts were 57% (6%) for RET, 58% (17%) for C-MET, and 55% (18%) for KRAS. For nsq pts for whom test results were available at time of analysis, an alteration in EGFR was detected in 16% (n=889), in ALK in 6% (n=327), in ROS-1 in 3% (n=156), in BRAF V600 in 2% (n=100), and RET fusions in 1% (n=30). For pts for whom test results were available at time of analysis, a C-MET exon 14 skipping alteration was detected in 2% (n=64, nsq), and 1% (n=4, sq), and a KRAS G12C alteration in 14% (n=611, nsq), and 2% (n=8, sq), and a TPS ≥50% was documented for 30% (n=1598, nsq) and 28% (n=380, sq) of pts.ConclusionsCRISP presents current real life data on molecular testing from all treatment sectors in Germany. Test rates for markers with more recently available targeted treatment options reached similar levels as for earlier established markers.Clinical trial identificationNCT02622581.Legal entity responsible for the studyAIO-Studien-gGbmH.FundingAmgen Ltd., AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co.KG, Bristol Myers Squibb GmbH & Co., KGaA, Celgene GmbH, Daiichi Sankyo Deutschland GmbH, Gilead Sciences GmbH, GSK Research & Development Limited, Janssen-Cilag GmbH, Lilly Deutschland GmbH, MSD Sharp & Dohme GmbH, Novartis Pharma GmbH, Pfizer Pharma GmbH, Regeneron GmbH, Roche Pharma AG, Takeda Pharma Vertrieb GmbH & Co.KG.DisclosureF. Griesinger: Financial Interests, Personal, Advisory Role: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Tesaro/GSK, Amgen, Sanofi, Daiichi Sankyo, BeiGene; Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Siemens, Tesaro/GSK, Amgen, Sanofi, Daiichi Sankyo, BeiGene; Financial Interests, Institutional, Funding: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Siemens, Amgen. W.E.E. Eberhardt: Financial Interests, Personal, Advisory Role: AstraZeneca, BMS, Roche, Sanofi-Aventis, MSD, Amgen, Takeda, Boehringer Ingelheim, Novartis, Pfizer, Bayer, Eli Lilly; Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Roche, Sanofi-Aventis, MSD, Amgen, Takeda, Boehringer Ingelheim, Novartis, Pfizer, Bayer, Eli Lilly; Financial Interests, Institutional, Funding: AstraZeneca. W. Weichert: Financial Interests, Personal, Advisory Board: Roche, MSD, AstraZeneca, Pfizer, Merck, Lilly, Boehringer Ingelheim, Novartis, Takeda, Amgen, Astellas, Janssen, BMS; Financial Interests, Personal, Speaker’s Bureau: Roche, MSD, AstraZeneca, Pfizer, Merck, Lilly, Boehringer Ingelheim, Novartis, Takeda, Amgen, Astellas, Janssen, BMS; Financial Interests, Institutional, Funding: Roche, MSD, BMS, Bruker. M. Sebastian: Financial Interests, Personal, Advisory Role: AstraZeneca, Amgen, Boehringer Ingelheim, Takeda, BMS, MSD, GSK, Merck-Serono, Novartis, Pfizer, Roche, Eli Lilly; Financial Interests, Personal, Invited Speaker: AstraZeneca, Amgen, Boehringer Ingelheim, Takeda, BMS, MSD, GSK, Merck-Serono, Novartis, Pfizer, Roche, Eli Lilly; Financial Interests, Institutional, Funding: AstraZeneca. M. Thomas: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, BeiGene, BMS, Boehringer Ingelheim, Celgene, Chugai, Daiichi Sankyo, GSK, Janssen, Lilly, Merck/MSD, Roche, Takeda, Sanofi; Financial Interests, Institutional, Funding: AstraZeneca, BMS, Merck, Roche, Takeda; Financial Interests, Personal, Other, Refunding of Travel Cost: AstraZeneca, Boehringer Ingelheim, BMS, Daiichi Sankyo, Janssen, Lilly, Merck/MSD, Novartis, Pfizer, Roche, Sanofi, Takeda. All other authors have declared no conflicts of interest.