Abstract 1325P
Background
Treatment for metastatic non-small cell lung cancer (NSCLC) stratified according to biomarker testing results was shown in clinical trials to have beneficial outcomes (out). Whether these improvements carry over into real-world routine therapy is of great interest for patients (pts) and physicians. Here we used the prospective, national clinical research platform CRISP to compare patient characteristics (chr) and out of pts with PD-L1 TPS≥50% tumours treated with checkpoint inhibitor monotherapy (CPI) who are deemed either potentially study-eligible (se) or non-study-eligible (n-se).
Methods
CRISP (NCT02622581) is a prospective, observational, open, multicentre, interdisciplinary clinical research platform that collects data on all (sequential) treatments, patient and tumour chr, biomarker testing, clinical and patient-reported out in ∼180 hospitals and practices in Germany. Currently 6300+ pts were recruited, who will be followed until death or end of project. Data from 493 pts with PD-L1 TPS≥50% recruited between 12/2015 and 06/2019 and receiving CPI as 1st-line treatment was analysed. Pts were deemed se if they had the following chr: ECOG=0-1, Stage IV, no brain metastases, no HIV or second tumour and no prior (neo-)adjuvant therapies.
Results
Of 473 analysed pts 191 pts were potentially se in reflection of inclusion criteria for clinical trials KEYNOTE 42 and 24, 282 pts were n-se representing the real-world pts population. Although both groups are similar in age (median 68 years, both) and CR/PR rates were comparable (1%[se] vs. 2%[n-se] and 21% vs. 22%) as well as rates of stopped treatments because of toxicity (10%, both), potentially se pts. had a longer PFS (10.0 months, 95% CI: 7.6-15.2 vs. 7.9 months, 95% CI: 6.0-10.6) and OS (23.3 months, 95% CI: 16.5-26.1 vs. 20.2 months, 95% CI: 15.9-26.2) than potentially n-se pts.
Conclusions
In recent years the use of CPI monotherapy in PD-L1 TPS≥50% pts increased in Germany, resulting in improved treatment out. Potentially study-eligible pts are profiting more than potentially non-study-eligible pts. The impact of CPI combination therapies or treatment without CPI on both pts groups, will be subject of future analyses.
Clinical trial identification
NCT02622581; Actual Study Start Date: December 2015.
Editorial acknowledgement
Legal entity responsible for the study
AIO-Studien-gGmbH.
Funding
AIO-Studien-gGmbH.
Disclosure
F. Griesinger: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: Siemens; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: Celgene; Financial Interests, Institutional, Research Grant: Eli Lilly; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Takeda; Financial Interests, Institutional, Research Grant: Siemens; Financial Interests, Institutional, Research Grant: Amgen. M. Sebastian: Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: AbbVie; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Invited Speaker: BioNTech; Financial Interests, Personal, Invited Speaker: CureVac; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Tesaro; Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Tesaro. W. Brückl: Financial Interests, Personal, Full or part-time Employment: Klinikum Nürnberg; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Chugai; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Licensing Fees: Stratifyer; Financial Interests, Personal, Licensing Fees: Siemens Healthcare; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Eli Lilly. H. Hummel: Financial Interests, Personal, Invited Speaker: Janssen-Cilag; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: BMS. J. Kern: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Amgen. C. Schumann: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche. C. Wesseler: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Eli Lilly. W. Weichert: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Speaker’s Bureau: Takeda; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Speaker’s Bureau: Amgen; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Speaker’s Bureau: Astellas; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Speaker’s Bureau: Merck; Financial Interests, Personal, Advisory Board: Illumina; Financial Interests, Personal, Speaker’s Bureau: Illumina; Financial Interests, Personal, Advisory Board: Siemens; Financial Interests, Personal, Speaker’s Bureau: Siemens; Financial Interests, Personal, Advisory Board: Agilent; Financial Interests, Personal, Speaker’s Bureau: Agilent; Financial Interests, Personal, Advisory Board: Molecular Health; Financial Interests, Personal, Speaker’s Bureau: Molecular Health. J. Schröder: Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Clovis Oncology GmbH; Financial Interests, Personal, Advisory Role: GSK; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: AOP; Financial Interests, Personal, Advisory Role: Searchlight; Financial Interests, Personal, Advisory Role: Pharma Partner; Financial Interests, Personal, Advisory Role: MediXline GmbH; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: HE Research GmbH; Financial Interests, Personal, Advisory Role: Octapharma; Financial Interests, Personal, Advisory Role: AbbVie; Financial Interests, Personal, Advisory Role: iOMEDICO; Non-Financial Interests, Personal, Member: Deutsche Krebsgesellschaft; Non-Financial Interests, Personal, Member: DGHO; Non-Financial Interests, Personal, Member: ESMO; Non-Financial Interests, Personal, Member: BNHO; Non-Financial Interests, Personal, Member: WINHO; Non-Financial Interests, Personal, Member: AKS; Non-Financial Interests, Personal, Member: ASCO. W.E.E. Eberhardt: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: AbbVie; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Janssen Cilag; Financial Interests, Personal, Invited Speaker: Baumgart Consult; Financial Interests, Institutional, Research Grant: Eli Lilly; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: AbbVie. M. Thomas: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Institutional, Research Grant: Takeda. All other authors have declared no conflicts of interest.