3764 - Patients with metastatic non-small cell lung cancer and targetable molecular alterations in Germany. Treatment and first outcome data 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) with targetable molecular alterations.

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. Progression-free survival (PFS) was determined in pts observed ≥1 year (recruited <06/2017 (n = 906), outcome sample (ous)).

Results

94%/65% of 1732/472 pts with non-squamous/squamous tumors were tested for any biomarker. In 2018 test rate was 96%/75% and 49%/33% were tested for all biomarkers (EGFR, ALK, ROS1, BRAF) with approved targeted therapies (aTT). An alteration in EGFR, ALK, ROS1 or BRAF was detected in 9%, 3%, 2%, and 2% of pts, respectively. Details on the type of alteration will be presented. Of pts with druggable EGFR mutation (EGFR+ pts, n = 149) 78% received EGFR-aTT in 1^st-line. In 2^nd-line, 20% received EGFR-aTT, 15% something else, 11% died prior to 2^nd-line, 54% were still in 1^st-line. Median PFS of EGFR+ pts was 7.1 months (n = 67, 61% events, 95%-CI 5.2-10.1), in total 46% (n = 31) of pts had died (ous). Of pts with druggable ALK alteration (n = 55), 47% received ALK-aTT in 1^st-line. In 2^nd-line, 22% received ALK-aTT, 11% something else, 13% died prior to 2^nd-line, 54% were still in 1^st-line. In the ous (n = 29), 55% (n = 16) of tumors had already progressed, in total 24% (n = 7) of pts had died. All 6 pts with druggable ROS1 alteration received chemotherapy as 1^st-line, while 6 of the 9 pts with druggable BRAF mutation and start of treatment in 2017/18 received a BRAF-ATT in 1^st-line.

Conclusions

CRISP presents current real life data from Germany. Pts are frequently tested for molecular alterations. While EGFR-aTT is well established as 1^st-line and first data are promising for BRAF-aTT, pts with ALK/ROS alteration do not seem to be routinely treated with 1^st-line aTT, reasons are not yet clear and will be further evaluated. Outcome of pts will be further analyzed after longer follow-up.

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 (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. 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; Honoraria (institution), 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): Takeda; Research grant / Funding (institution): Roche. 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): Takeda; Research grant / Funding (institution): Roche. 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: Honoraria (institution), Advisory / Consultancy: MSD Sharp & Dohme; Honoraria (institution), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (institution), Advisory / Consultancy: Lilly; Honoraria (institution), Advisory / Consultancy: AstraZeneca; Honoraria (institution), Advisory / Consultancy: Roche; Honoraria (institution), Advisory / Consultancy: Pfizer; Honoraria (institution), Advisory / Consultancy: Celgene; Honoraria (institution), Advisory / Consultancy: Novartis. All other authors have declared no conflicts of interest.