# Lutetium-177 PNT2002

Source: https://nuclide.cc/drugs/lu-177-pnt2002/  
Nuclide record `lu-177-pnt2002` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

A radioactive drug that homes in on a marker found on most prostate cancer cells, delivering radiation directly to the tumour, is being tested as a treatment for prostate cancer that has stopped responding to hormone therapy.

## Summary

177Lu-PNT2002 is a PSMA-targeted radioligand therapy built on the PSMA-I&T ligand, labelled with beta-emitting no-carrier-added lutetium-177. POINT Biopharma developed it and Lantheus in-licensed exclusive worldwide commercial rights (excluding certain Asian territories) in December 2022; POINT was subsequently acquired by Eli Lilly. The FDA granted Fast Track designation for metastatic castration-resistant prostate cancer (mCRPC) in April 2023.

The pivotal phase 3 SPLASH trial (NCT04647526) randomised 412 patients with PSMA-expressing mCRPC who had progressed on an androgen receptor pathway inhibitor (ARPI) and refused or were ineligible for chemotherapy, 2:1 to 177Lu-PNT2002 (up to four cycles, 6.8 GBq per cycle every 8 weeks) versus a change to abiraterone or enzalutamide, with crossover allowed on progression. Topline results (December 2023) showed a statistically significant improvement in radiographic progression-free survival by blinded independent central review: median 9.5 months with 177Lu-PNT2002 versus 6.0 months with ARPI (HR 0.71, p=0.0088); overall survival was immature, with an interim HR of 1.11, and 84.6% of control-arm patients who progressed crossed over. Grade 3+ treatment-emergent adverse events, serious adverse events and discontinuations for toxicity were all numerically lower on 177Lu-PNT2002 than on ARPI.

As of the March 2026 status, 177Lu-PNT2002 has not received a marketing authorisation in any jurisdiction; further follow-up data were expected in 2024 ahead of a potential US new drug application.

## Fields

- Kind: Agent
- Status: phase-3
- Last checked: 2026-09-22
- Also known as: 177Lu-PNT2002; 177Lu-PSMA-I&T (POINT/Lantheus)
- Tags: PSMA; radioligand therapy; prostate cancer; beta emitter; phase 3
- Code: PNT2002
- Modality: radioligand therapy
- Mechanism: A PSMA-targeted small-molecule ligand (PSMA-I&T) labelled with no-carrier-added lutetium-177, a beta emitter, delivering targeted radiation to PSMA-expressing prostate cancer cells after intravenous infusion.
- Dosing: Intravenous infusion; Up to 4 cycles at 6.8 GBq (±10%) per cycle, every 8 weeks (SPLASH trial regimen)

## Sources

- Lantheus/POINT: positive topline SPLASH results, 18 December 2023: https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-and-point-biopharma-announce-positive-topline-results
- FDA Fast Track designation announcement, 24 April 2023: https://investor.lantheus.com/node/14596/pdf
- Initial clinical experience with 177Lu-PNT2002 (SPLASH lead-in), PMC 2025: https://pmc.ncbi.nlm.nih.gov/articles/PMC11745944/
- ClinicalTrials.gov: SPLASH (NCT04647526): https://clinicaltrials.gov/study/NCT04647526

## Connected records

- drugs: [177Lu-PSMA-I&T](https://nuclide.cc/drugs/lu177-psma-it/), [Lutetium-177 vipivotide tetraxetan](https://nuclide.cc/drugs/pluvicto/)
- isotopes: [Lutetium-177](https://nuclide.cc/isotopes/lu-177/)
- indications: [Metastatic castration-resistant prostate cancer](https://nuclide.cc/indications/prostate-mcrpc/)
- technologies: [Radioligand therapy (beta emitters)](https://nuclide.cc/technologies/radioligand-therapy/)
- targets: [PSMA](https://nuclide.cc/targets/psma/)
- companies: [Eli Lilly (incl. Loxo)](https://nuclide.cc/companies/eli-lilly/), [Lantheus](https://nuclide.cc/companies/lantheus/), [POINT Biopharma](https://nuclide.cc/companies/point-biopharma/)
- trials: [SPLASH](https://nuclide.cc/trials/splash/)

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