KEY TAKEAWAYS
- Phase 3 VISION trial evaluated the effectiveness of 177Lu-PSMA-617 in combination with standard of care in patients with mCRPC that tested positive for PSMA and showed signs of progression.
- The trial’s primary aim was to assess the rPFS and OS of patients treated with 177Lu-PSMA-617 in combination with standard of care.
- Patients were classified into four subgroups based on the magnitude of confirmed best PSA decline from baseline and PSA levels.
- The study found a significant correlation between the extent of PSA reduction from the initial level and extended rPFS and OS in individuals with mCRPC.
- Patients with PSA declines > 50 – ≤ 90% and > 90% had an 80% and 96% reduced risk of radiographic disease progression and a 58% and 90% reduced risk of death.
- The findings suggest that the decrease in PSA levels has significant predictive value for the prognosis of clinical outcomes in patients undergoing radioligand therapy with 177Lu-PSMA-617.
The results of the phase 3 VISION trial indicate that the administration of lutetium (177Lu) vipivotide tetraxetan ([177Lu]Lu-PSMA-617; 177Lu-PSMA-617) in combination with standard of care (SoC) treatment, as permitted by the protocol, led to a significant extension of radiographic progression-free survival (rPFS) and overall survival (OS) in patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) that tested positive for prostate-specific membrane antigen (PSMA) and showed signs of progression. The observed percentage of patients who exhibited a verified decrease from their initial prostate-specific antigen (PSA) level by at least 50% was greater in those who received treatment with 177Lu-PSMA-617 in addition to standard of care (SoC) therapy compared to those who only received SoC. This exploratory analysis was conducted post hoc to assess the correlations between the extent of prostate-specific antigen (PSA) reduction from baseline and clinical outcomes in the group treated with 177Lu-PSMA-617.
Patients in the 177Lu-PSMA-617 group were classified into four subgroups by the magnitude of confirmed best PSA decline from baseline: no decline; ≤ 50% decline; > 50 – ≤ 90% decline; and > 90% decline (cut-off date: 27 January 2021). Prostate-specific antigen (PSA) levels were evaluated at the initial assessment and the commencement of every six-week treatment cycle. The estimation of median overall survival (OS) and radiographic progression-free survival (rPFS) was conducted using the Kaplan-Meier methodology. Cox proportional-hazards regression was utilized to estimate the hazard ratios (HRs). An association was observed between an increased decline in PSA levels from the baseline and a longer radiographic progression-free survival (rPFS) and overall survival (OS) in the group treated with 177Lu-PSMA-617, as shown in the table. Patients with PSA declines > 50 – ≤ 90% and > 90% had an 80% and 96% reduced risk of radiographic disease progression and a 58% and 90% reduced risk of death, respectively, versus those with no decline.
The study findings indicate a significant correlation between the extent of prostate-specific antigen (PSA) reduction from the initial level and extended radiographic progression-free survival (rPFS) and overall survival (OS) in individuals diagnosed with metastatic castration-resistant prostate cancer (mCRPC) who underwent treatment with 177Lu-PSMA-617 in combination with standard of care (SoC). The aforementioned observation indicates that the decrease in PSA levels holds significant predictive value for the prognosis of clinical outcomes in patients undergoing radioligand therapy with 177Lu-PSMA-617.
Source: https://oncologypro.esmo.org/meeting-resources/esmo-congress/association-between-prostate-specific-antigen-decline-and-clinical-outcomes-in-patients-with-metastatic-castration-resistant-prostate-cancer-in-the
Clinical Trail: https://clinicaltrials.gov/ct2/show/NCT03511664
A.J. Armstrong, O. Sartor, F. Saad, J. Czernin, N.D. Shore, A.T. Kendi, T.M. Beer, N. Vaishampayan, G. El-Haddad, J. Wu, O. Mirante, M.J. Morris/1372P – Association between prostate-specific antigen decline and clinical outcomes in patients with metastatic castration-resistant prostate cancer in the VISION trial/Annals of Oncology (2022) 33 (suppl_7): S616-S652. 10.1016/annonc/annonc1070
