Abstract 1364P
Background
Details on the current treatment and outcome of patients (pts) with advanced NSCLC and mutations in the KRAS gene in routine care are scarce. Considering recent developments regarding specific small molecule inhibitors of the KRAS mutation subtype G12C, we analyzed patient characteristics, treatment reality and outcome in a representative advanced NSCLC (stage IIIB/C, IV) cohort in Germany with KRAS G12C and non-G12C mutations.
Methods
Pts with advanced, non-squamous NSCLC and KRAS mutations were identified within the 3,717 pts recruited into the prospective, multicenter, observational registry CRISP from December 2015 to June 2019 in Germany. Details on pts’ characteristics, treatment and outcome were analyzed in the subgroups of KRAS G12C and non-G12C mutated pts.
Results
A total of 441 pts with KRAS-mutated advanced non-squamous NSCLC were recruited into the CRISP registry. KRAS G12C was present in 171/3717 cases (4.6%), non-KRAS G12C in 270 (7.3%). Median age with KRAS G12C (non-G12C) mutations was 64 years, respectively; 45.0% (46.3%) were female, ECOG PS was 0 in 36.8% (34.8%), and 93.0% (84.1%) were current/former smokers; 35.7% (27.0%) had bone metastases (mets), 27.5% (24.4%) CNS mets, and 15.2% (7.4%) liver mets. In total, 48.5% (40.7%) received a checkpoint-inhibitor single agent or combined with chemotherapy in first-line treatment, 38.6% (47.4%) received platinum-combination therapies. So far, second-line treatments have been documented for 48 pts (G12C) and 92 pts (non-G12C). Of these second-line treatments, 27 (56.3%) pts with G12C and 60 (63.8%) with non-G12C mutations received a checkpoint-inhibitor. Survival was similar for pts with KRAS G12C and non-G12C mutations: median PFS [months] was 4.4 (95% CI 3.2-6.4) vs. 4.8 (95% CI 4.3-5.7); median OS [months] was 10.1 (95% CI 7.0-12.3) vs. 9.4 (95% CI 7.1-10.8).
Conclusions
These comprehensive, representative, prospectively collected real-world data on pts with advanced NSCLC and KRAS mutations shed light on the pts’ characteristics and current treatment and may well serve as important historical control for clinical studies on the treatment and outcome of this patient subgroup.
Clinical trial identification
NCT02622581.
Editorial acknowledgement
Stephanie Dille (iOMEDICO AG).
Legal entity responsible for the study
AIO-Studien gGmbH.
Funding
CRISP is supported by Grants from AstraZeneca GmbH, Amgen Ltd., 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), Research grant/Funding (institution), Non-remunerated activity/ies: AstraZeneca; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: Böhringer Ingelheim; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: Bristol-Myer Squibb; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: Celgene; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: MSD; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: Novartis; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: Pfizer; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: Roche; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: Takeda; Honoraria (self), Research grant/Funding (institution), Non-remunerated activity/ies: Lilly; Honoraria (self), Research grant/Funding (institution): Siemens; Honoraria (self), Research grant/Funding (institution): Amgen. P. Hoffknecht: Advisory/Consultancy: Böhringer Ingelheim; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Takeda; Advisory/Consultancy: Roche Pharma; Advisory/Consultancy: Lilly; Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: AbbVie. M. Metzenmacher: Advisory/Consultancy: Takeda; Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: Roche; Advisory/Consultancy: Böhringer Ingelheim. W. Schütte: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Honoraria (self): Lilly; Honoraria (self): Amgen; Honoraria (self): Merck. W. Weichert: Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Merck; Advisory/Consultancy: Lilly; Advisory/Consultancy: Böhringer Ingelheim; Advisory/Consultancy: Novartis; Advisory/Consultancy: Takeda; Advisory/Consultancy: Amgen; Advisory/Consultancy: Astellas; Research grant/Funding (institution): Bruker. M. Groschek: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche Pharma; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Celgene; Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Onkovis; Research grant/Funding (institution), Travel/Accommodation/Expenses: Medac; Travel/Accommodation/Expenses: Gilead; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (self): Amgen; Honoraria (self), Research grant/Funding (institution): Merck; Research grant/Funding (institution): iOMEDICO; Research grant/Funding (institution): Pierre Fabre; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Octapharma; Research grant/Funding (institution): Teva. E. von der Heyde: Honoraria (institution), Advisory/Consultancy: BMS; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: AstraZeneca; Research grant/Funding (institution): Böhringer Ingelheim; Research grant/Funding (institution): Ipsen. J. Rauh: Honoraria (institution), trial participation: Sanofi; Honoraria (institution), trial participation: Ipsen; Honoraria (institution), trial participation: Böhringer Ingelheim; Honoraria (institution), trial participation: iOMEDICO AG. M. Sebastian: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Böhringer Ingelheim; Honoraria (self), Advisory/Consultancy: Celgene; Honoraria (self): Biontech; Honoraria (self): CureVac; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy: Tesaro. M. Thomas: Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): BMS; Honoraria (self): Böhringer Ingelheim; Honoraria (self): Celgene; Honoraria (self): Chugai; Honoraria (self): Lilly; Honoraria (self): MSD; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self), Research grant/Funding (institution): Takeda. All other authors have declared no conflicts of interest.