Lutetium-177 vipivotide tetraxetan, trade name Pluvicto, also known as 177Lu-PSMA-617, is a theranostic (i.e. both therapeutic and diagnostic) agent approved as a treatment for adult patients with treatment-resistant advanced metastatic prostate cancer. The treatment works by binding to cancer cells that express prostate-specific membrane antigen (PSMA), a biomarker associated with poor prognosis, and inducing cell death through the cytotoxic effects of radioactive Lu-177.
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Characteristics
Decay:
Lu-177 has a half-life of 6.65 days
gamma emission – 208 keV, used for imaging
beta minus decay – beta particle average penetration of 0.67 mm with maximum of 2 mm allows for decreased effect on surrounding normal tissue
Lutetium-177 vipivotide tetraxetan primarily undergoes renal excretion.
Use
Pre-treatment PET scan is performed using a PSMA-linked agent. 68Ga PSMA-11 (trade name Illuccix) was utilized in the VISION trial. Additional PSMA diagnostic agents include 18F piflufolastat (trade name Pylarify), 68Ga gozetotide (trade name Locametz), and 18F Flotufolastat (trade name Posluma).
Lutetium-177 vipivotide tetraxetan is administered intravenously at a dose of 200 mCi (7.4 GBq) every 6 weeks up to 6 doses. Dosage and timing may be adjusted if patient has disease progression or severe side effects.
Potential Side Effects
fatigue, decreased appetite
dry mouth, nausea, vomiting
myelosuppression: lymphopenia, anemia, thrombocytopenia
hypocalcemia, hyponatremia
renal toxicity
Of note, this therapy has not been tested in female patients.
History and Manufacture
The VISION trial was the phase III international trial that compared outcomes in 831 patients treated with 177Lu-PSMA-617 plus standard of care treatment versus standard of care treatment alone. It found that median survival increased from 11.3 to 15.3 months with 177Lu-PSMA-617. Progression-free survival was an average of 8.7 months versus 3.4 months with standard of care therapy alone.
Pluvicto was FDA approved on March 23, 2022, for use in patients with PSMA-positive metastatic prostate cancer that did not respond to androgen deprivation therapy (i.e., castration resistant) or taxane-based chemotherapy.
In the United States, Pluvicto is manufactured by Advanced Accelerator Applications, part of Novartis.
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