Clinical outcomes of [ 177 Lu]Lu-DOTA-TATE ( 177 Lu-DOTATATE) vs everolimus (EVE) in managing patients (pts) with gastroenteropancreatic-neuroendocrine tumors (GEP-NETs): Real-world analysis of the PRIME initiative.

627 Background: GEP-NETs arise from neuroendocrine cells of the digestive tract (88%) or pancreas (12%). Therapies for progressive GEP-NETs include surgery, somatostatin analogs (SSA), chemotherapy, targeted therapy, and radioligand therapy. 177 Lu-DOTATATE is a radiolabeled SSA approved for progressive GEP-NETs based on NETTER-1 and shown to be an effective first-line therapy for Grade 2 and 3 GEP-NETs in NETTER-2. Prior to 177 Lu-DOTATATE approval, EVE, a mammalian target of rapamycin inhibitor, was the recommended therapy for progressive GEP-NETs. Here we describe pt characteristics and real-world outcomes of 177 Lu-DOTATATE vs EVE in pts with GEP-NETs. Methods: This was a retrospective, non-interventional, cohort study of pts treated with 177 Lu-DOTATATE or EVE using data from the open-source IQVIA Longitudinal Prescription and Pt Centric Medical Claims databases between Jul 1, 2017–Feb 28, 2025, representing the largest analysis of real-world GEP-NET data to date. Pt characteristics were assessed using descriptive statistics from 6 months prior to the index date (date of earliest evidence of 177 Lu-DOTATATE or EVE initiation). Following propensity-score matching of cohorts, overall survival (OS) and time to next systemic treatment (TTNT) were assessed with Kaplan–Meier and Cox models from index date to the end of follow-up. Results: The study included 5367 pts treated with 177 Lu-DOTATATE (n=3410) or EVE (n=1957). Prior to matching, pt characteristics were comparable between 177 Lu-DOTATATE and EVE groups, with a median (range) age of 67 (18–85) vs 65 (18–85) years. Prior exposure to systemic therapies was higher with 177 Lu-DOTATATE (68%) vs EVE (59%), with only 5% prior EVE exposure in the 177 Lu-DOTATATE group. The most common comorbidities in pts included hypertension (38% vs 37%); liver, gallbladder, and pancreatic diseases (29% vs 28%); and diabetes (24% vs 26%) for 177 Lu-DOTATATE vs EVE, respectively. Post-matching, the median (95% CI) TTNT was not reached (NR) (70.2 months–NR) with 177 Lu-DOTATATE (n=1559) vs 29.0 (25.2–34.6) months with EVE (n=1559) (p