Pluvicto extends radiographic PFS in prostate cancer subset
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Lutetium Lu 177 vipivotide tetraxetan improved radiographic PFS compared with androgen receptor pathway inhibitor therapy among certain men with pretreated prostate cancer, according to the agent’s manufacturer.
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) is the first targeted radioligand therapy for treatment of progressive, prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer. PSMA is highly expressed in more than 80% of men with prostate cancer.
The agent is approved in the United States for treatment of men with PSMA-positive metastatic castration-resistant prostate cancer treated with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy.
The randomized phase 3 PSMAfore study included 469 men with PSMA-positive metastatic castration-resistant prostate cancer whose disease progressed after treatment with a second-generation ARPI but had not received taxane-based chemotherapy.
Researchers randomly assigned the men to lutetium Lu 177 vipivotide tetraxetan or a change in ARPI therapy.
Results showed a statistically significant improvement in radiographic PFS — the study’s primary endpoint — with lutetium Lu 177 vipivotide tetraxetan.
“With the announcement of these positive topline phase 3 results, Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate significant and clinically meaningful benefits for people living with this type of prostate cancer who have not received taxane-based chemotherapy,” Shreeram Aradhye, MD, president of global drug development and chief medical officer of Novartis, said in a company-issued press release. “We look forward to discussing the data with [health care] authorities in order to bring this innovative new early treatment option to many more [patients with prostate cancer] sooner after their diagnosis.”
Safety data from PSMAfore appeared consistent with prior reports, according to investigators. Full data from the trial will be presented at a medical meeting.
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