449PDPrecision medicine: Preliminary results from the initiative for molecular profiling and advanced cancer therapy 2 (IMPACT 2) study

Abstract Background Precision medicine is associated with favorable outcomes in selected patients. We initiated IMPACT 2, a randomized study to compare PFS in patients with metastatic cancer treated on the basis of tumor genomic profiling results vs. those whose treatment was not selected based on genomic analysis. Herein, we assessed the association between patient characteristics and overall survival (OS). Methods Patients with advanced, metastatic cancer underwent tumor biopsy and genomic profiling (Foundation One). Variants were filtered to eliminate germline mutations (annotation, ANNOVAR) and artifacts. Patients were presented at tumor board and were randomized if they met criteria for clinical trials. OS was measured from enrollment on study until last follow-up or death from any cause. Results From 5/2014 to 4/2017, 320 of 391 enrolled patients completed tumor profiling. Baseline characteristics (n = 320) were as follows: men, 47%; median age, 63 yrs (range, 25-83); performance status 1, 88%; median no. of prior therapies, 3 (range, 0-14); liver metastases, 40%; albumin 618 IU/L, 29%; platelet count > or Table . 449PD Multivariate analysis, OS Risk Factor HR 95% CI P Age ≥ 60 yrs 1.02 1.00-1.03 .009 Liver metastases 1.43 1.07-1.91 .02 LDH > 618 IU/L 2.19 1.61-2.97 Albumin 1.90 1.26-2.87 .002 KRAS mutated 2.27 1.57-3.28 TP53 mutated 1.38 1.04-1.84 .03 Conclusions In patients with metastatic cancer, age Clinical trial identification www.clinicaltrials.gov NCT02152254, First posted June 2, 2014. Legal entity responsible for the study The authors. Funding Foundation Medicine. Disclosure A.M. Tsimberidou: Research grant / Funding (institution): IMMATICS; Research grant / Funding (institution): Tempus; Research grant / Funding (institution): Parker Institute for Cancer Immunotherapy; Research grant / Funding (institution): EMD Serono; Research grant / Funding (institution): Baxalta; Research grant / Funding (institution): Foundation Medicine; Research grant / Funding (institution): Boston Biomedical; Research grant / Funding (institution): Placon Therapeutics; Research grant / Funding (institution): Karus Therapeutics; Research grant / Funding (institution): Tvardi; Research grant / Funding (institution): OBI Pharma; Advisory / Consultancy: Roche, Europe; Advisory / Consultancy: Covance; Advisory / Consultancy: Genentech. D.S. Hong: Research grant / Funding (self): Adaptimmune; Research grant / Funding (institution): Abbvie; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (self): Bayer; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Daichi-Sanko; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Genmab; Research grant / Funding (institution): Ignyta; Research grant / Funding (institution): Infinity; Research grant / Funding (institution): Kite; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): LOXO; Research grant / Funding (institution): Mirati; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): Molecular Template; Research grant / Funding (institution): Novartis. All other authors have declared no conflicts of interest.