3775 - Patients with metastatic non-small cell lung cancer without molecular alterations or PD-L1 expression in Germany. Treatment and first outcome from the prospective German Registry Platform CRISP (AIO-TRK-0315)

Background

Guidelines for metastatic non-small cell lung cancer recommend stratified treatment by biomarker test results. We used CRISP to evaluate treatment and outcome of patients (pts) in whom neither targetable molecular alterations nor any PD-L1 expression were detected.

Methods

Currently 163 sites in Germany have recruited >3700 pts at start of 1^st-line who will be followed until death or end of project. Data from 2204 pts recruited by 133 sites from 12/2015 to 06/2018 was analyzed. These pts started treatment prior approval of immune checkpoint inhibitors (ICI) for this group of pts. Progression-free survival (PFS) was determined in pts ≥1 year under observation (recruited until 06/2017 (n = 906), outcome sample (ous)).

Results

6% of pts with non-squamous (nsq) and 35% with squamous (sq) tumors received no type of biomarker testing prior to start of 1^st-line, and in 49% and 36% no targetable alterations or any PD-L1 expression were detected. Thus, 55% and 71% of pts (nsq/sq) were eligible for chemotherapy (ctx) but no type of targeted therapy at start of 1^st-line. Median age at start of 1^st-line was 66 and 68 years (nsq/sq). 29%/23% had ECOG=0 and 82%/90% ≤1 comorbidity. 10%/6% were never-smokers. In 1^st-line, pts received carboplatin- (55%) or cisplatin-based ctx (24%), 13% targeted therapy (e.g. ICI in trial, switch to TKI but test result not yet documented). At database cut, 33% of all pts had started 2^nd-line, 24% had died prior to a 2^nd-line and remaining pts were still in 1^st-line. In the ous, median PFS was 5.0 months (66% events, 95%-CI 4.5-5.5 months, n = 457) for nsq tumors and 4.5 months (66% events, 95%-CI 3.4-5.3 months, n = 154) for sq tumors. In total 55% of pts with nsq and 53% of pts with sq tumors had died.

Conclusions

CRISP presents current real life data from Germany. Despite break-throughs with targeted therapies and high test rates in routine care, the majority of pts do not qualify for targeted therapy because no targetable alterations are found. First outcome results indicate that prognosis is poor in these pts. Outcome will hopefully improve in the cohort now treated with ctx-ICI combination.

Clinical trial identification

NCT02622581.

Editorial acknowledgement

Legal entity responsible for the study

AIO-Studien-gGmbH.

Funding

AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Celgene GmbH, MSD Sharp & Dohme GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, Pfizer Pharma GmbH, Roche Pharma AG, and Takeda Pharma Vertriebs GmbH & Co. KG.

Disclosure

F. Griesinger: Honoraria (self), Advisory / Consultancy: Ariad; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myer-Squibb; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Celgene; Honoraria (self), Advisory / Consultancy: Clovis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck-Sharp-Dome; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche. N.W. Marschner: Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy, Research grant / Funding (institution): MSD Sharp & Dohme ; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Leadership role, Shareholder / Stockholder / Stock options, Officer / Board of Directors: iOMEDICO. M. Jänicke: Leadership role, Full / Part-time employment: iOMEDICO. A. Fleitz: Full / Part-time employment: iOMEDICO. L. Spring: Full / Part-time employment: iOMEDICO. J. Sahlmann: Leadership role, Full / Part-time employment: iOMEDICO. A. Karatas: Research grant / Funding (institution): AstraZeneca ; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): MSD Sharp & Dohme; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Takeda. A. Hipper: Research grant / Funding (institution): Takeda; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): MSD Sharp & Dohme; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): AstraZeneca. M. Sebastian: Advisory / Consultancy: Bristol-Myers Squibb ; Advisory / Consultancy: MSD Sharp & Dohme ; Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim Pharma; Advisory / Consultancy: Celgene; Advisory / Consultancy: Lilly; Advisory / Consultancy: Pfizer. M. Thomas: Advisory / Consultancy, Travel / Accommodation / Expenses: MSD Sharp & Dohme ; Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb ; Advisory / Consultancy, Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca ; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Travel / Accommodation / Expenses: Celgene; Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis. All other authors have declared no conflicts of interest.