Lutetium Lu-177 vipivotide tetraxetan

Overview

Lutetium Lu-177 vipivotide tetraxetan is a radioligand therapeutic agent. It consists of a radionuclide, lutetium Lu-177, linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer. Lutetium Lu-177 vipivotide tetraxetan was first approved by the FDA on March 23, 2022 as a treatment for prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended lutetium Lu-177 vipivotide tetraxetan be granted marketing authorization for the treatment of prostate cancer. In December 2022, lutetium Lu-177 vipivotide tetraxetan was approved by the EMA.

Background

Indication

Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.

Associated Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC	2023/05/08	NCT05849298	Phase 2	Recruiting	Novartis Pharmaceuticals
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer	2023/04/07	NCT05803941	Phase 4	Recruiting	Novartis Pharmaceuticals
Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer	2023/03/13	NCT05766371	Phase 2	Recruiting	University of California, San Francisco
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC	2023/01/12	NCT05682443	Phase 1	Recruiting	OncoC4, Inc.
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	2023/01/04	NCT05670106	Phase 2	Active, not recruiting	Novartis Pharmaceuticals
A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer	2022/12/20	NCT05658003	Phase 2	Active, not recruiting	Novartis Pharmaceuticals
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy	2022/09/29	NCT05560659	Phase 2	Recruiting	Peter MacCallum Cancer Centre, Australia
Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer	2022/04/22	NCT05340374	Phase 1	Active, not recruiting	Peter MacCallum Cancer Centre, Australia
EBRT + Lu-PSMA for N1M0 Prostate Cancer	2021/12/17	NCT05162573	Phase 1	Recruiting	The Netherlands Cancer Institute
EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC	2021/12/09	NCT05150236	Phase 2	Active, not recruiting	Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Title

Posted

Study ID

Phase

Status

Sponsor

A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

2023/05/08

NCT05849298

Phase 2

Recruiting

Novartis Pharmaceuticals