3970 - Patients with metastatic non-small cell lung cancer and PD-L1 expression in Germany. Treatment and first outcome from the prospective German Registry Platform CRISP (AIO-TRK-0315)

Background

Treatment guidelines for metastatic non-small cell lung cancer recommend stratified treatment according to biomarker testing results. Here we used CRISP to evaluate treatment and outcome of patients (pts) with PD-L1-expressing tumors.

Methods

Currently 163 centers in Germany have recruited over 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 centers between 12/2015 and 06/ 2018 was analyzed regarding PD-L1 testing, treatment and outcome. Progression-free survival (PFS) was determined in patients being ≥1 year under observation (recruited until June 30^th 2017 (n = 906), outcome sample, (ous)).

Results

Test rates for PD-L1 increased from 25% (2016) to 75% (2018) in pts with non-squamous tumors (n = 1732), and from 20% (2016) to 62% (2018) in pts with squamous tumors (n = 472). Of pts with test results (n = 1221) PD-L1 antibodies mostly used were Ventana SP263 (19%), DAKO 28-8 or 22-C (8% each) or not known to the documenting site (56%). PD-L1 TPS was ≥50% in 16% of pts, 1-49% in 18% of pts, and <1% in 7% of pts, while 3%/12% of pts were classified by pathologists as PD-L1 positive/negative with TPS not specified. In 9% and 4% an EGFR or ALK alteration was also detected, respectively. Of all pts with PD-L1 TPS≥50% 70% received pembrolizumab-based 1^st-line treatment, 21% chemotherapy and 9% another/targeted therapy. At database cut, 20% had started 2^nd-line, 19% had died prior to a 2^nd-line and remaining pts were still in 1^st-line. In the ous, median PFS of all pts with PD-L1 positive tumors was 4.4 months (62% events, 95%-CI 3.5-5.5 months, n = 185), in pts with PD-L1 TPS≥50% (n = 83) so far 53% had a progression after 1^st-line. In total, 49% of pts with PD-L1 positive tumors and 41% of pts with PD-L1 TPS≥50% had died (ous).

Conclusions

CRISP presents current real life data from Germany. Testing for PD-L1 has been quickly integrated into routine care diagnostics. The majority of pts with PD-L1 positive tumors and a TPS≥50% receive an immune-oncology therapy. The impact of these novel targeted treatment approaches on the outcome of pts will be subject of future analyses.

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

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. 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; Honoraria (institution), 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): 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. F. Griesinger: Honoraria (institution), Advisory / Consultancy: Ariad; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myer-Squibb; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Celgene; Honoraria (institution), Advisory / Consultancy: Clovis; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Lilly; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Merck-Sharp-Dome; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Roche. M. Thomas: Advisory / Consultancy: MSD Sharp & Dohme; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Lilly; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Novartis. All other authors have declared no conflicts of interest.