Community oncologists’ perceptions of and barriers to access for <sup>177</sup>LU-PSMA-617 in metastatic castration-resistant prostate cancer.
Authors: Ajeet Gajra, Ricardo Estupinian, Stephanie Fortier, Yolaine Jeune-Smith, Bruce A. Feinberg, Ulka N. Vaishampayan
Journal: Journal of Clinical Oncology (2022)

120 Background: Metastatic castration-resistant prostate cancer (mCRPC) is a difficult-to-treat cancer with poor patient outcomes. In June 2021, 177 Lu-PSMA-617 was granted U.S. FDA breakthrough designation for the treatment of mCRPC based on results from the phase III VISION trial showing a 4-month increased median overall survival (15.3 v 11.3 m; HR 0.62 [0.52-0.74], P &lt; 0.001) and a 5.3-month increased radiographic progression-free survival (8.7 v 3.4 m; HR 0.40 [0.29-0.57] for 177 Lu-PSMA-617 versus standard of care (SOC). If approved, 177 Lu-PSMA-617 has the potential to improve patient outcomes, but its impact will depend significantly on how community-based medical oncologists (cbMO) plan to integrate it into patient management. The present study surveyed cbMO regarding their perceptions of the VISION trial data and potential barriers to 177 Lu-PSMA-617 use in mCRPC. Methods: Between June and October 2021, practicing U.S.-based cbMO were invited to attend a virtual meeting and were presented with the VISION trial data. Their reactions to the data and preferences were collected using audience response technology. Results are presented using descriptive statistics. Results: Among the 287 participating cbMO, median years in practice was 17 (1-45), and median time spent in direct patient care was 90% (20-100%). In the past year, 46% of cbMO managed 6-15 patients with mCRPC, and 27% managed 16 or more. CbMO reported that at the time of referral, their patients with mCRPC had commonly been treated with androgen deprivation therapy (77%) and one (49%) or two plus (20%) novel hormonal agents. After reviewing the recent data from the VISION trial showing improved survival outcomes in mCRPC, 51% of cbMO reported that both the safety and efficacy data were compelling, and they were very likely to prescribe 177 Lu-PSMA-617 if approved; 33% indicated that the efficacy data alone was compelling and were likely to prescribe 177 Lu-PSMA-617. The top 2 limitations of the VISION trial were identified as PSMA gallium positivity for eligibility (54%) and the disallowance of radium-223 on the SOC arm (48%). Regarding perceived barriers to future use of 177 Lu-PSMA-617, 68% and 64% of cbMO reported availability of a PSMA-gallium scan and availability/access of the therapy itself, respectively, would be the greatest barriers. Additional barriers included cost (42%) and difficulty with reimbursement (30%), highlighting the importance of addressing access and financial considerations associated with 177 Lu-PSMA-617. Conclusions: Most cbMO found the VISION trial data of 177 Lu-PSMA-617 in mCRPC compelling and indicated that they are likely to incorporate it into their patient management, if approved. However, major barriers such as the incorporation of PSMA-gallium scans, 177 Lu-PSMA-617 availability, and cost will need to be addressed to encourage widespread adoption of this new therapy.