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)

Purpose: Treatment guidelines for stage IV NSCLC recommend stratified treatment according to biomarker testing results. 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 4255 pts at start of 1st-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 30th 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). 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 1st-line treatment, 21% chemotherapy and 9% another/targeted therapy. At database cut, 20% had started 2nd-line, 19% had died prior to a 2nd-line and remaining pts were still in 1st-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 1st-line. In total, 49% of pts with PD-L1 positive tumors and 41% of pts with PD-L1 TPS ≥ 50% had died (ous).

Conclusions: 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.

Disclosure Statement: None of the authors has declared a conflict of interest regarding the subject of this work. Acknowledgements: CRISP supported by AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Lilly Deutschland, MSD Sharp & Dohme, Novartis Pharma, Pfizer Pharma, Roche Pharma and Takeda Pharma Vertrieb.