Patient characteristics and overall survival with lutetium (Lu ¹⁷⁷ ) vipivotide tetraxetan ( ¹⁷⁷ Lu-PSMA-617): A real-world analysis of early adopters.

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Background: ¹⁷⁷ Lu-PSMA-617, a prostate-specific membrane antigen (PSMA)-targeting radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC), received FDA approval in March 2022 for the treatment of adult patients with PSMA-positive mCRPC who have received both an androgen receptor pathway inhibitor (ARPI) and a taxane-based chemotherapy. Outside of clinical trials, limited real-world evidence evaluating the effectiveness of ¹⁷⁷ Lu-PSMA-617 has been reported. The aim of the current study was to evaluate patient characteristics and overall survival (OS) among patients diagnosed with mCRPC who were treated with ¹⁷⁷ Lu-PSMA-617 within a large-scale real-world cohort. Methods: This retrospective, observational study used the IQVIA PharMetrics Plus claims data from July 1, 2013 to December 31, 2023, and linked social determinants of health data as well as mortality data to obtain month and year of death. Adult men with mCRPC who had received ¹⁷⁷ Lu-PSMA-617 were included (first receipt of ¹⁷⁷ Lu-PSMA-617 = index date). Patient demographics and characteristics were evaluated descriptively; patient demographics were reported on the index date and clinical characteristics were evaluated over the 12 months prior to index date. OS was measured from the start of the first ¹⁷⁷ Lu-PSMA-617 treatment until death or end of available follow-up, and assessed using Kaplan–Meier analysis. Results: A total of 643 patients were included in the analysis; median age was 69 years. Treatment for the majority of patients (490/643 [76.2%]) was managed by oncologists (169 [26.3%] of which had specialty in radiation oncology). White patients (292 [72.8%]) made up the largest part of the patient population followed by Black (37 [9.2%]), Hispanic (23 [5.7%]), and Asian (8 [2.0%]). Most patients had multiple comorbidities with either one (226/643 [35.1%]) or two (224/643 [34.8%]) sites of metastasis. Most patients experienced bone metastases (581/643 [90.4%]); 284/643 (44.2%) also experienced visceral metastases of which the liver was the most common site (78/643 [12.1%]). The median OS from start of ¹⁷⁷ Lu-PSMA-617 therapy was 15.3 months (95% confidence interval [CI]: 14.6–16.3); a total of 137/643 (21.3%) patients died. OS was analyzed in different patient subgroups and no major differences were observed by metastatic site, number of metastatic sites, race, or age. Conclusions: To our knowledge, this is the first large-scale study reporting OS with ¹⁷⁷ Lu-PSMA-617 in clinical practice. OS observed with ¹⁷⁷ Lu-PSMA-617 in this study (median: 15.3 months) was consistent with results from the VISION Phase III clinical trial (median: 15.3 months; NCT03511664). Furthermore, ¹⁷⁷ Lu-PSMA-617 demonstrated similar survival across different patient subgroups.