A novel radiopharmaceutical has been shown to boost survival when added to standard treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease had progressed after chemotherapy and the use of androgen inhibitors.
The agent, lutetium-labeled PSMA-617 (177Lu PSMA-617), which is under development by Endocyte/Novartis, delivers high doses of beta radiation to prostate cancer cells.
It achieves this by binding to prostate-specific membrane antigen (PSMA), which is highly expressed on the surface of prostate cancer across the disease spectrum and across disease sites. Expression on normal tissue is limited.
The new results come from the VISION phase 3 open-label trial and are planned to be used in applications for US Food and Drug Administration (FDA) approval of this new agent in this indication.
"These findings warrant adoption of 177Lu PSMA-617 as a new treatment option in this patient population," said lead researcher Michael J. Morris, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, New York City.
"There are ongoing studies in patients with prostate cancer at earlier phases of the disease using this agent," he said.
The new results will be presented on June 6 at the plenary session of the American Society of Clinical Oncology (ASCO) annual meeting, but some details were released early at a premeeting press briefing.
Results From Earlier Phase 2 Trial
Earlier results with the novel radiopharmaceutical from a phase 2 trial known as TheraP were published in February 2021 in The Lancet. These results showed that 177Lu PSMA-617 was more active than cabazitaxel against mCRPC and led to fewer grade 3–4 adverse events.
As reported by Medscape Medical News at the time, 66% of men given 177Lu PSMA-617 achieved a 50% reduction in prostate-specific antigen levels (PSA50) from baseline, vs 37% of those treated with cabazitaxel.
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