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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:
PSMA inhibitor, Beta radiation emitter
15h
New P2 trial • Metastases
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carboplatin • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
7d
Post Marketing Study on Pluvicto in Korea (clinicaltrials.gov)
P=N/A, N=278, Not yet recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2027 --> Mar 2029 | Initiation date: Oct 2024 --> May 2025 | Trial primary completion date: Jul 2027 --> Mar 2029
Trial completion date • Trial initiation date • Trial primary completion date • Real-world evidence • Real-world
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
13d
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2026 --> Aug 2025 | Trial primary completion date: Jan 2026 --> Dec 2024
Trial completion date • Trial primary completion date • Metastases
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
17d
A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer (clinicaltrials.gov)
P1, N=27, Recruiting, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Recruiting
Enrollment open • Metastases
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EGFR (Epidermal growth factor receptor)
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
20d
Intratumoral Distribution of [177Lu]Lu-PSMA-617 Over Time and in Relation to Diagnostic Tracers in Animal Models of Prostate Cancer. (PubMed, Cancer Biother Radiopharm)
Regrowth of the tumor post-[177Lu]Lu-PSMA-617 administration creates Ki67+/PSMA+ areas that have no radioactivity uptake and need additional therapy fractions. The identical intratumoral distribution of [177Lu]Lu-PSMA-617 and PSMA-targeted PET-tracers indicate that these will reveal the areas inside the tumor targeted by RPT at least at 1 h p.i.
Preclinical • Journal
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FOLH1 (Folate hydrolase 1)
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FOLH1 expression
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
22d
New P4 trial
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
27d
PSMA Radiotheranostics in Prostate Cancer: Principles, Practice, and Future Prospects. (PubMed, Radiographics)
The U.S. Food and Drug Administration approval of 177Lu-PSMA-617 marked a substantial advancement in the treatment paradigm of metastatic castration-resistant prostate cancer, based on the VISION trial that showed improved overall survival and quality of life compared with those for standard care...This review underscores the role of PSMA radioligand therapy in the evolving landscape of prostate cancer treatment and its promise for improving patient outcomes.
Review • Journal
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FOLH1 (Folate hydrolase 1)
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FOLH1 expression
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
29d
Enrollment change
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abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • AAA817
29d
Enrollment open • Metastases
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
1m
LuTectomy: Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy (clinicaltrials.gov)
P1/2, N=20, Active, not recruiting, Peter MacCallum Cancer Centre, Australia | Trial completion date: Dec 2023 --> Aug 2025
Trial completion date
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
Bullseye: Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
P2, N=58, Active, not recruiting, Radboud University Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Mar 2025
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
Enrollment closed • Combination therapy • Metastases
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FOLH1 positive
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
2ms
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (clinicaltrials.gov)
P2, N=474, Not yet recruiting, Alliance for Clinical Trials in Oncology
New P2 trial
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carboplatin • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Ezharmia (valemetostat)
3ms
(SEEtoTREAT): SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (clinicaltrials.gov)
P=N/A, N=80, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Initiation date: Sep 2024 --> Dec 2024
Trial initiation date
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • Xofigo (radium Ra-223 dichloride)
3ms
Trial initiation date • Metastases
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
3ms
Intensification Approaches and Treatment Sequencing in Metastatic Castration-resistant Prostate Cancer: A Systematic Review. (PubMed, Eur Urol)
Recent approvals and ongoing investigations of single agents and intensification approaches will keep transforming the mCRPC treatment landscape. Improvement of patient profiling applying recognized genomic, molecular, and clinical predictive and prognostic indicators is fundamental to optimize sequential use of available therapies.
Review • Journal • BRCA Biomarker • Metastases
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PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
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BRCA2 mutation
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docetaxel • Xtandi (enzalutamide) • abiraterone acetate • ipatasertib (RG7440) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
3ms
Initial Experience with [177Lu]Lu-PSMA-617 After Regulatory Approval for Metastatic Castration-Resistant Prostate Cancer: Efficacy, Safety, and Outcome Prediction. (PubMed, J Nucl Med)
Artificial-intelligence-based analysis of baseline PSMA PET/CT images may improve patient selection. Validation of these findings on larger cohorts is warranted.
Journal • Metastases
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HRD (Homologous Recombination Deficiency)
|
FOLH1 positive
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
3ms
A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer (clinicaltrials.gov)
P1, N=6, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor)
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
3ms
Enrollment open • Combination therapy • Metastases
|
FOLH1 positive
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
3ms
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (clinicaltrials.gov)
P2, N=80, Recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2028 --> Apr 2026
Trial completion date • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
3ms
LUNAAR: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer (clinicaltrials.gov)
P1/2, N=0, Withdrawn, Baptist Health South Florida | N=30 --> 0 | Trial completion date: Jul 2028 --> Oct 2028 | Initiation date: Jul 2024 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2026 --> Oct 2026
Enrollment change • Trial completion date • Trial initiation date • Trial withdrawal • Trial primary completion date • Metastases
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Zejula (niraparib) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Akeega (abiraterone/niraparib)
4ms
Detection of tumour heterogeneity in patients with advanced, metastatic castration-resistant prostate cancer on [68Ga]Ga-/[18F]F-PSMA-11/-1007, [68Ga]Ga-FAPI-46 and 2-[18F]FDG PET/CT: a pilot study. (PubMed, Eur J Nucl Med Mol Imaging)
Through whole-body imaging, we identify considerable inter- and intra-patient heterogeneity of mCRPC and potential imaging phenotypes. Regarding uptake and tumour detection, [68Ga]Ga-/[18F]F-PSMA-11/-1007 was superior to [68Ga]Ga-FAPI-46 and 2-[18F]FDG, while the latter two were comparable. Patients who underwent [177Lu]Lu-PSMA-617 RLT based on clinical-decision making had a longer overall survival and could be assigned to the PSMA-dominant phenotype.
Journal • FDG PET • Metastases
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FOLH1 (Folate hydrolase 1)
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
4ms
CCTG PR21: 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer (clinicaltrials.gov)
P2, N=200, Active, not recruiting, Canadian Cancer Trials Group | Trial primary completion date: Jul 2024 --> Dec 2024
Trial primary completion date
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docetaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
4ms
Enrollment open • Metastases
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Zolinza (vorinostat) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
4ms
Enrollment open • Metastases
|
docetaxel • Zejula (niraparib) • Xtandi (enzalutamide) • abiraterone acetate • Erleada (apalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Akeega (abiraterone/niraparib)
4ms
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (clinicaltrials.gov)
P2, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Initiation date: Dec 2024 --> Aug 2024 | Not yet recruiting --> Recruiting
Enrollment open • Trial initiation date • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
4ms
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) (clinicaltrials.gov)
P2, N=90, Recruiting, Jonsson Comprehensive Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Dec 2024 --> Aug 2024
Enrollment open • Trial initiation date • Metastases
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
4ms
Enrollment open • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • AAA603
5ms
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (clinicaltrials.gov)
P2, N=80, Recruiting, Novartis Pharmaceuticals | Trial completion date: Apr 2026 --> Nov 2028
Trial completion date • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
5ms
New P2 trial • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
5ms
New P1 trial • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
5ms
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (clinicaltrials.gov)
P2, N=40, Not yet recruiting, Jonsson Comprehensive Cancer Center | Initiation date: Jun 2024 --> Dec 2024
Trial initiation date • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
5ms
Post Marketing Study on Pluvicto in Korea (clinicaltrials.gov)
P=N/A, N=278, Not yet recruiting, Novartis Pharmaceuticals
New trial • Real-world evidence • Real-world
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
5ms
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) (clinicaltrials.gov)
P2, N=90, Not yet recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Feb 2028 --> Dec 2028 | Initiation date: Jul 2024 --> Dec 2024 | Trial primary completion date: Feb 2027 --> Dec 2027
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
5ms
New P3 trial • Metastases
|
docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • Erleada (apalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
5ms
Biological determinants of PSMA expression, regulation and heterogeneity in prostate cancer. (PubMed, Nat Rev Urol)
The PSMA-targeted theranostic 177Lu-PSMA-617 was approved in 2022 for men with PSMA-PET-positive metastatic castration-resistant prostate cancer...PSMA response and resistance to radioligand therapy are mediated by a number of potential mechanisms, and complementary biomarkers beyond PSMA are under development. Understanding the biological determinants of cell surface target regulation and heterogeneity can inform precision medicine approaches to PSMA theranostics as well as other emerging therapies.
Review • Journal
|
FOLH1 (Folate hydrolase 1)
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
6ms
PSMACare: A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC (clinicaltrials.gov)
P2, N=120, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Dec 2028 --> Oct 2027
Trial primary completion date • Combination therapy
|
Xtandi (enzalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
6ms
(SEEtoTREAT): SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (clinicaltrials.gov)
P=N/A, N=80, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: May 2029 --> Aug 2029 | Initiation date: May 2024 --> Aug 2024 | Trial primary completion date: May 2028 --> Aug 2028
Trial completion date • Trial initiation date • Trial primary completion date
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • Xofigo (radium Ra-223 dichloride)
6ms
Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan (clinicaltrials.gov)
P4, N=30, Recruiting, Brigham and Women's Hospital | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
6ms
New trial • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)