First 1000 patients report of global practice patterns and clinical outcomes in the Collaborative Ocular Melanoma Natural History (OMNi) real-world database (NCT04588662).

Abstract

9595 Background: OMNi (NCT04588662) is an ambispective natural history database developed to provide contemporary real-world data of UM. The overall objectives of OMNi are to characterize regional/international UM management practice patterns and associated clinical outcomes in an effort to inform best practice recommendations and provide real world evidence. Here we present characteristics, demographics and practice patterns in the first 1000 patients enrolled globally. Methods: OMNi utilizes the Pulse Infoframe Healthie platform, enabling the longitudinal structured collection of data mapped to Observational Medical Outcomes Partnership. Results: Median age at diagnosis was 60 (15-94), with 47% of patients were female. Enrolment was from Australia (309), UK (93), USA (121) and Canada (477). When known, family history of UM was present in 2% (15/733). Recorded primary treatment modalities included plaque brachytherapy 44%, Enucleation 18%, Stereotactic radiotherapy 9%, Proton beam 3%, other radiotherapy 1%, other/ unknown 23%. Within the cohort, 30 patients were diagnosed with de novo metastatic disease and 343 patients had metastatic disease at any time. Of those, metastatic location was 166 extrahepatic and hepatic, 154 hepatic only, 18 extrahepatic only. HLA-A2 status was *0201 in 172/ 297(58%). Systemic treatments were administered to 176 patients first line– Tebentafusp (71 fist line); Ipi/Nivo (58); Ipi (7); PD-1 inh (15). The total number of patients receiving systemic treatments were Tebentafusp 108; Ipi/Nivo 90; Ipi 22; PD-1 (82). In total, 133 patients received liver directed therapy. At last follow up, where available 29% of patients had died from UM (179/611). Data to be presented will include genetic profiling summaries. Conclusions: The OMNi dataset can serve and aid in interpretation of clinical trial outcomes in the real-world, and accelerate the development of diagnostics and therapeutics to provide comparative data.