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DRUG:

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

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Other names: 177 Lu PSMA-617, Lu177-PSMA-617, Lu177 RLT, 177LU-PSMA-617, PSMA-617, 177lutetium-PSMA-617, AAA617, AAA-617, AAA 617
Company:
Novartis, Otsuka
Drug class:
Beta radiation emitter, PSMA inhibitor
Related drugs:
1m
Metastatic Unfunctional Pancreatic Neuroendocrine Tumor in Lynch Syndrome. (PubMed, Clin Case Rep)
Liver lesions shrank after treatment with octreotide and Lutetium-177 vipivotide tetraxetan...The role of microsatellite instability (MSI) as a screening marker, and personalized treatment approaches like immunotherapy for dMMR tumors. Understanding these correlations may assist in early discovery, surveillance, and customized treatment for patients dealing with LS-associated malignancies.
Journal • IO biomarker
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
1m
New P4 trial
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Nubeqa (darolutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Apr 2033 --> Jul 2033 | Initiation date: Apr 2026 --> Jul 2026 | Trial primary completion date: Apr 2032 --> Jul 2032
Trial completion date • Trial initiation date • Trial primary completion date
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
ENZA-p: Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
P2, N=162, Active, not recruiting, Australian and New Zealand Urogenital and Prostate Cancer Trials Group | Trial completion date: Jan 2025 --> Dec 2026
Trial completion date
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enzalutamide • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
New P2 trial
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abiraterone acetate • Eligard (leuprolide acetate) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Viadur (leuprorelin implant) • Yonsa (abiraterone acetate)
2ms
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial (clinicaltrials.gov)
P3, N=1524, Recruiting, Alliance for Clinical Trials in Oncology | Not yet recruiting --> Recruiting | Initiation date: Oct 2025 --> Mar 2026
Enrollment open • Trial initiation date
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FOLH1 positive
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function (clinicaltrials.gov)
P2, N=23, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2026 --> Dec 2026
Enrollment closed • Trial completion date • Trial primary completion date
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
Natural Flavonoids Genistein and Baicalein as Well-Tolerated Radiosensitizers to Enhance the Efficacy of 177Lu-PSMA617 in Prostate Cancer: In Vitro and In Vivo Studies. (PubMed, Research (Wash D C))
Their natural origin and established safety profile underscore their translational potential. Thus, genistein and baicalein represent promising novel adjuvants for prostate cancer radioligand therapy.
Preclinical • Journal
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CASP3 (Caspase 3)
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=42, Recruiting, Weill Medical College of Cornell University | N=20 --> 42 | Active, not recruiting --> Recruiting
Enrollment open • Enrollment change
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CELLSEARCH®
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Ac-225 rosopatamab tetraxetan (CONV01-α)
2ms
Effects of androgen receptor signaling inhibitors on absorbed doses in mCRPC patients undergoing [177Lu]Lu-PSMA-617 or [177Lu]Lu-PSMA-I&T therapy: dosimetry results. (PubMed, Eur J Nucl Med Mol Imaging)
In this pilot cohort, concomitant ARSi therapy did not significantly enhance tumor absorbed doses in patients receiving [177Lu]Lu-PSMA-617 or [177Lu]Lu-PSMA-I&T RLT. Further prospective studies with larger patient numbers are needed to evaluate the impact of concomitant ARSi treatment on the absorbed doses in mCRPC tumor lesions.
Journal
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FOLH1 (Folate hydrolase 1) • ARSI (Arylsulfatase Family Member I)
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FOLH1 expression
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enzalutamide • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
Lanmodulin-Engineered Outer Membrane Vesicles for Synergistic Targeted Radio-Immunotherapy. (PubMed, ACS Nano)
In a head-to-head comparison with clinically approved 177Lu-PSMA-617 (Pluvicto), PSMA-targeted TRT@LnOMVs achieved a 90% survival rate in a prostate cancer model, far surpassing the 25% survival rate of Pluvicto...This occurred through reprogramming immunosuppressive myeloid compartments (including neutrophil subsets and macrophages), expanding cytotoxic CD8+ T and NK cell infiltration, and activating innate immunity to trigger robust antitumor responses. Collectively, TRT@LnOMVs represent a versatile class of biohybrid therapeutics, offering a robust paradigm for next-generation radio-immunotherapy.
Journal
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CD8 (cluster of differentiation 8)
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)