Lutetium-177 (177Lu)-PSMA-617 is a radiolabeled small molecule that binds with high affinity to prostate-specific membrane antigen (PSMA), which is highly expressed on the surface of 80% of prostate cancer cells with only limited expression in normal tissue.
This makes PSMA "an excellent target for targeted systemic radiation treatment, which is known as radioligand therapy," Dr. Michael Morris of Memorial Sloan Kettering Cancer Center, in New York City, said at the American Society of Clinical Oncology (ASCO) virtual annual meeting, where he presented the findings.
The VISION study enrolled 831 men with PSMA-expressing mCRPC previously treated with androgen-receptor-pathway inhibitors and one to two taxane chemotherapy regimens. "These men had few remaining treatment options," Dr. Morris said. They were randomly allocated (2:1) to Lu-PSMA-617 plus standard of care or standard of care only.
Treatment with Lu-PSMA-617 led to a 38% reduction (P<0.001) in the risk of death and prolonged median overall survival from 11.3 months to 15.3 months.
Lu-PSMA-617 treatment also reduced the risk of radiographic progression or death by 60% and improved median radiographic progression-free survival from 3.4 without Lu-PSMA-617 to 8.7 months with the radioligand therapy.
There were more high-grade treatment-emergent adverse events with Lu-PSMA-617 (52.7% vs. 38.0%), but there were no unexpected or concerning safety signals.
Summing up, Dr. Morris said this study demonstrated that patients with mCRPC, "who have already progressed after both androgen-receptor-pathway inhibitors and chemotherapy had significantly improved overall survival and radiographic progression-free survival if they received lutetium PSMA in addition to safely combinable standards of care relative to those standards alone."
"The treatment was safe and well tolerated with no new safety signals. These findings do warrant adoption of lutetium-PSMA as a new treatment option in this patient population, pending (Food and Drug Administration) review. There are ongoing studies in patients with prostate cancer at earlier phases of the disease using this agent," Dr. Morris said.
ASCO President Dr. Lori Pierce said, "This trial shows an alternative to traditional therapies by using radiation targeted to the prostate-specific membrane antigen, so it can be delivered directly to the prostate cancer cells, and by doing that survival was significantly improved. Use of this PSMA radioligand therapy, if it obtains regulatory approval, could indeed become an important treatment option for these patients with refractory disease."
Dr. Ash Tewari, professor of urology at Mount Sinai Health System in New York City, said this is an important study that "gives new hope for the patients with advanced prostate cancer."
"Androgen deprivation is the mainstay of therapy of advanced prostate cancer but the cure rate is low and patients eventually become castrate resistant," Dr. Tewari, who was not involved in the study, told Reuters Health by email. "Despite the numerous treatment options for mCRPC, the impact on survival is less than optimal. There is a need to more closely tailor therapies to individual patient profiles. The identification of new molecular-target PSMA against which specific radiation may be delivered may improve tailored treatment in mCRPC."
The study was funded by Endocyte, a Novartis company, which is developing this therapy. Several authors have disclosed financial relationships with the company.
SOURCE: https://bit.ly/2SOIaFs American Society of Clinical Oncology annual meeting, held June 4-8, 2021.
By Megan Brooks
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