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Clinical Trial Progress
Clinical Trial Progress
Clinical Data
Clinical Data
Pluvicto™ (Lutetium-177 Vipivotide Tetraxetan) FDA approved in the VISION Phase III randomized, multicenter, open-labeled clinical trial of 831 patients with progressive PSMA-positive mCPRC. The approval was based on the two alternative primary endpoints of radiographic progression-free survive (rPFS) and overall survival (OS) in patients with the PSMA-positive MCRPC when treated with Pluvicto + BSoC, or BSoc alone.
Arms and Interventions
Arms and Interventions
Patients received 7.4 GBq (+/- 10%) Pluvicto intravenously every 6 weeks (+/- 1) up to 6 doses and/or BSoC
After 4 cycles, patients were assessed for evidence of response, residual disease and tolerance to Pluvicto
If all 3 assessments were met, patients might receive 2 more additional cycles
Best supportive/best standard of care defined via local investigator
Key Findings
Key Findings
Statisically significant improvement in both OS and rRPFs in patients treated with Pluvicto + BSOC compared to patients treated with BSOC alone
Median OS in patients treated w/ Pluvicto + BSoC was 15.3 months compared w. 11.3 months in BSoC only
38% reduced risk of death for patients treated w/ Pluvicto + BSoC compared to alone.
Side effects
Side effects
Common adverse effects - Fatigue (43%), dry mouth (39%), nausea (35%), anemia (32%), decreased appetite (21%) and constipation (20%)
Most common labs abnormalities - decreased lymphocytes lvls, hemoglobin, leukocytes, platelets, calcium and sodium
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