Lu 177 Vipivotide Tetraxetan Approved for PSMA-Positive mCRPC

Richard L. Wahl, MD, director of the Mallinckrodt Institute of Radiology and Elizabeth E. Mallinckrodt Professor of Radiology at Washington University School of Medicine in St. Louis, discusses the approval of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

Lu 177 vipivotide tetraxetan is a nuclear medicine therapy that targets the PSMA protein expressed in prostate cancer to deliver radiation to the tumor. The high expression of PSMA on the surface of tumor cells enables this therapy to selectively target prostate cancer cells. According to Wahl, a PSMA-PET scan can determine if patients with mCRPC have high PSMA expression and are eligible for this therapy.

The FDA approved Lu 177 vipivotide tetraxetan for patients with PSMA-positive mCRPC following the phase 3 VISION trial (NCT03511664). Patients must have been treated with taxane-based chemotherapy and androgen receptor pathway inhibitors.

The results of the VISION trial showed that patients who received Lu 177 vipivotide tetraxetan plus standard of care had a 38% reduction in risk of death versus those who received standard of care alone. It also had an overall response rate of 30% versus only 2% for those who received standard of care.

TRANSCRIPTION:

0:08 | This particular therapy—Pluvicto is the name—targets the PSMA protein that's on the surface of prostate cancer. This nuclear medicine therapy is a radioactive molecule that will accumulate in foci of PSMA expression. Most metastatic prostate cancers have a lot of this PSMA on their surface, so this lutetium-177 labeled molecule, when it's injected, will hone in to those tumors and deliver radiation selectively to the tumor in comparison to most normal tissues. It's a targeted therapy but the target is an actual physical target of this radioactive molecule.

0:59 | Pluvicto is now FDA approved in patients who have this metastatic prostate cancer that have the PSMA expression as evidenced by a PSMA-PET scan. That's another nuclear medicine procedure, so there's a scan with a PET scanner to see if a small, safe tracer dose of the PSMA-targeting agent will accumulate in tumors and if those tumors do accumulate to a sufficient extent, then they will be candidates for the therapy. These would be patients who were hormone-refractory…whose tumors no longer responded to chemotherapy including a taxane-based chemotherapy. Long story short, [this is] a radioactive molecule that hones [in] to PSMA that selectively treats those tumors in patients where other more standard therapies have failed.