Real-world data highlight clinical benefit of 177Lu-PSMA-617 in mCRPC

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“This data supports the clinical benefit of 177Lu-PSMA-617 in real-world clinical practice,” the researchers wrote in their poster conclusion.

Real-world data demonstrate the clinical efficacy of the radioligand therapy 177Lu-PSMA-617 (lutetium Lu 177 vipivotide tetraxetan; Pluvicto) in patients with heavily pretreated metastatic-castration resistant prostate cancer (mCRPC), according to findings from a single-institution retrospective analysis shared at the 2024 Genitourinary Cancers Symposium.1

Regarding next steps, the authors wrote, “Characterization of response rates within subgroups by prior treatment and disease characteristics are ongoing.”

Regarding next steps, the authors wrote, “Characterization of response rates within subgroups by prior treatment and disease characteristics are ongoing.”

At a median follow-up of 7.6 months (range, 0.6-14.1), 21% of patients had a PSA90 response, 52% had a PSA50 response, and 61% had a PSA30 response. Twenty-eight percent of patients had an increase or no change in PSA from baseline. Of note, 3 patients with an initial rise in PSA after their first treatment experienced a subsequent decline from their baseline PSA level.

“This data supports the clinical benefit of 177Lu-PSMA-617 in real-world clinical practice,” the researchers wrote in their poster conclusion.

Overall, the retrospective analysis included the first 100 patients with mCRPC treated with a minimum of 1 cycle of 177Lu-PSMA-617 at Duke University from June 2022 to August 2023. Of these 100 patients, 98 were evaluable for efficacy. There were 2 patients determined to be ineligible for the analysis because they had received 177Lu-PSMA-617 on a prior clinical trial.

For the 98 eligible patients, the median age at diagnosis was 61 years (range, 46-89) and the median age at the start of treatment was 72 years (range, 50-93). Over two-thirds (69%) of the patients were white, 28% were Black or African American, 1% were American Indian or Alaskan Native, and 2% preferred not to answer questions about race.

The median baseline PSA level was 25.96 ng/mL (range, 3.87-5030) and the median Gleason score at diagnosis was 8 (range, 6-10). Forty-four percent of patients had de novo metastatic disease. Sites of metastases included bone plus nodal metastases (44%), bone metastases only (19%), nodal metastases only (8%), and liver metastases only (11%). Regarding prior treatment, 47% of patients had at least 2 prior androgen receptor signaling inhibitors, 48% had at least 2 prior taxanes, 42% had 1 prior taxane, and 17% had prior radium-223 (Xofigo).

The primary outcome measure was best PSA response, focusing on a PSA reduction from baseline of 30% (PSA30), 50% (PSA50), or 90% (PSA90) at any time point during treatment.

The researchers noted on their poster that their results are limited by “duration of response and time to follow-up.”

Regarding next steps, the authors wrote, “Characterization of response rates within subgroups by prior treatment and disease characteristics are ongoing.”

FDA approval of 177Lu-PSMA-617

177Lu-PSMA-617 is approved by the FDA for the treatment of adult patients with PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.2

The approval was based on findings from the phase 3 VISION trial (NCT03511664), which showed that adding 177Lu-PSMA-617 to standard of care significantly improved overall survival and progression-free survival compared with standard of care alone in patients with advanced PSMA-positive mCRPC.3

Reference

1. Maldonado Grijalva V, Wang J, Nedrud M, et al. Real-world clinical outcomes of patients treated with Lu-177-PSMA-617 for metastatic castration-resistant prostate cancer (mCRPC): A single-institution experience. J Clin Oncol 42, 2024 (suppl 4; abstr 83) doi: 10.1200/JCO.2024.42.4_suppl.83

2. FDA approves Pluvicto for metastatic castration-resistant prostate cancer. Published online March 23, 2022. Accessed November 29, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer.

3. Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322

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