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• W2978984983 abstract "Abstract Background ROS1 fusions are found in 1% of lung cancer patients. EUCROSS is the first prospective European trial to evaluate crizotinib in this patient subset. Here we present an updated analysis of the progression-free survival (PFS), overall survival (OS) and molecular characteristics of progression. Methods Multi-centre, single arm phase II trial. Key eligibility criteria: ≥18 years of age, advanced/metastatic lung cancer, centrally confirmed ROS1-rearrangement. Treatment: 250 mg crizotinib BID. Key endpoints of this report: updated PFS (according to RECIST 1.1) and OS and molecular tumour characterization. Results Thirty patients were eligible for response evaluation (N = 30; intention-to-treat population, N = 34). Median follow-up was 44.9 months (95% CI, 39.6-47.4). At data-cut off 19 patients (63.3%) discontinued treatment due to progression or death. Investigator-assessed efficacy: ORR, 70% (95% CI, 51–85; 21/30); disease control rate, 90.0% (95% CI, 73.5-97.9; 27/30); median PFS, 19.4 months (95% CI, 10.1-31.2); 24-months-OS probability, 65.5% (95% CI, 48.3-82.9). Prevalence of co-occurring genetic aberrations by hybrid-capture sequencing was 61%. TP53 mutations were most frequent (28%; 5/18). PFS (p = 0.0219) and OS at 24 months (p = 0.015) were significantly shorter in TP53-mutant patients. Tissue or blood samples were collected in six patients at progression. In three (50%) samples, secondary mutations in ROS1 (i.e. p.G2032R (N = 2), p.L2026M (N = 1)) were detected. In one (17%), a PIK3CA mutation (p.E545K) was identified. In the other two patients (33%) aberrations of unknown significance were detected. Conclusions Updated PFS and OS results confirm the efficacy of crizotinib in ROS1-rearranged lung cancer patients. Patients with co-mutations in TP53 had significantly worse outcomes compared to TP53 wild-type patients. The most common mechanisms of resistance were mutations in ROS1. Next-generation ROS1 inhibitors or the multi-kinase inhibitor cabozantinib may be promising treatment options for these patients. Clinical trial identification NCT02183870. Legal entity responsible for the study University Hospital of Cologne. Funding Pfizer. Disclosure S. Michels: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self): Boehringer Ingelheim; Research grant / Funding (institution): Janssen; Honoraria (self): Roche. B. Massuti Sureda: Honoraria (self): Merck Sharp Dome; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Roche; Honoraria (self): Pfizer. H. Schildhaus: Honoraria (self): ZytoVision; Honoraria (self): Pfizer; Honoraria (self), Research grant / Funding (institution): Roche; Honoraria (self), Research grant / Funding (institution): Novartis. M. Sebastian: Honoraria (self): Boehringer Ingelheim; Honoraria (self): Eli Lilly; Honoraria (self): Pfizer; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Merck Sharp Dome; Honoraria (self): Takeda; Honoraria (self): Mediolanum; Honoraria (self): AbbVie; Honoraria (self): Celgene. E. Felip: Honoraria (self): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Celgene; Honoraria (self): Eli Lilly; Honoraria (self): Guardiant; Honoraria (self): Merck Sharp Dome; Honoraria (self): Merck KGa; Honoraria (self): Novartis. M. Reck: Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): AstraZeneca; Honoraria (self): Abbot; Honoraria (self): Celgene; Honoraria (self): Merck Sharp Dome; Honoraria (self): Merck KGa; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Roche. S. Merkelbach-Bruse: Honoraria (self): Pfizer; Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Roche; Honoraria (self), Research grant / Funding (institution): Novartis. L. Nogova: Honoraria (self), Research grant / Funding (institution): Pfizer; Honoraria (self), Research grant / Funding (institution): Novartis; Honoraria (self), Research grant / Funding (institution): Janssen; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Roche; Honoraria (self): Celgene. J. Wolf: Honoraria (self), Research grant / Funding (institution): Novartis; Honoraria (self), Research grant / Funding (institution): Pfizer; Honoraria (self), Research grant / Funding (institution): Janssen; Honoraria (self): Boehringer Ingelheim; Honoraria (self): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self): Chugay; Honoraria (self): Ignyta; Honoraria (self): Eli Lilly; Honoraria (self): Merck Sharp Dome; Honoraria (self): Roche. All other authors have declared no conflicts of interest." @default.
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• W2978984983 date "2019-10-01" @default.
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• W2978984983 title "Crizotinib in patients with advanced or metastatic ROS1-rearranged lung cancer (EUCROSS): A European phase II clinical trial – Updated progression-free survival, overall survival and mechanisms of resistance" @default.
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