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)

Purpose: Guidelines for stage IV NSCLC 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 > 4255 pts at start of 1st-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 1st-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 1st-line.

In 1st-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 2nd-line, 24% had died prior to a 2nd-line and remaining pts were still in 1st-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: Despite break-throughs with targeted therapies and high test rates in routine care, the majority of pts do not qualify for targeted therapy. First outcome results indicate that prognosis is poor in these pts. Outcome will hopefully improve in the cohort now treated with ctx-ICI combination. 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.