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PEER-TO-PEER CLINICAL CONVERSATION
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FDA Approval of 177Lu-PSMA-617 (Pluvicto®) for Taxane-Naive, PSMA-Positive mCRPC Following ARPI
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A. Oliver Sartor, MD
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| Zachary Klaassen speaks with Oliver Sartor about the FDA's expanded approval of Pluvicto™ (177Lu-PSMA-617) for metastatic castration-resistant prostate cancer patients in the taxane-naive setting. Dr. Sartor discusses the PSMAfore trial that led to this approval, highlighting the 59% improvement in time to progression compared to second hormonal therapy.
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FDA Approves Novartis Radioligand Therapy Pluvicto® for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
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| Press Release |
| The FDA has approved Novartis’ radioligand therapy Pluvicto® for earlier use in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), expanding its indication to patients who have received one androgen receptor pathway inhibitor (ARPI) but have not yet undergone chemotherapy. The approval is based on the Phase III PSMAfore trial, where Pluvicto reduced the risk of radiographic progression or death by 59% and more than doubled median progression-free survival compared to a second ARPI. |
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| Association of Baseline and On-Treatment ctDNA Fraction with Clinical Outcomes in Patients with mCRPC in the PSMAfore Study of 177Lu-PSMA-617
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| Johann De Bono, MD, MSc, PhD, FRCP
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| The PSMAfore study presented at ASCO GU 2025 evaluated the association of baseline and on-treatment circulating tumor DNA (ctDNA) fraction with clinical outcomes in patients with PSMA-positive mCRPC treated with 177Lu-PSMA-617. Higher ctDNA fractions were linked to shorter radiographic progression-free survival (rPFS) and overall survival (OS), with stronger associations at cycle 2, day 1 than at baseline.
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| PSMAfore Phase 3 Trial of [177Lu]Lu-PSMA-617 in Taxane-Naive Patients with Metastatic Castration-Resistant Prostate Cancer
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| A. Oliver Sartor, MD
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| The PSMAfore Phase 3 trial, presented at ESMO 2023, evaluated 177Lu-PSMA-617 in taxane-naive patients with PSMA-positive mCRPC, demonstrating a significant improvement in radiographic progression-free survival compared to androgen receptor pathway inhibitor (ARPI) change. Secondary endpoints, including PSA response, objective response rate, and time to symptomatic skeletal events, also favored 177Lu-PSMA-617.
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| PSMAfore Discussant: Using Clinical Intelligence to Define First Line mCRPC Therapy |
| Christopher Sweeney, MBBS |
| Christopher Sweeney’s discussant presentation at ESMO 2023 contextualized the PSMAfore Phase 3 trial results, emphasizing both its strengths and limitations. While the study confirmed 177Lu-PSMA-617's efficacy in taxane-naive mCRPC patients—demonstrating cancer regression, delayed progression, improved quality of life, and pain control—rPFS remains a modest endpoint compared to OS, and long-term safety data is still needed. |
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