{"entity":{"id":"lu-177-pnt2002","kind":"drug","name":"Lutetium-177 PNT2002","aka":["177Lu-PNT2002","177Lu-PSMA-I&T (POINT/Lantheus)"],"tldr":"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.\n\nThe 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.\n\nAs 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.","status":"phase-3","asOf":"2026-09-22","links":[{"label":"Lantheus/POINT: positive topline SPLASH results, 18 December 2023","url":"https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-and-point-biopharma-announce-positive-topline-results"},{"label":"FDA Fast Track designation announcement, 24 April 2023","url":"https://investor.lantheus.com/node/14596/pdf"},{"label":"Initial clinical experience with 177Lu-PNT2002 (SPLASH lead-in), PMC 2025","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11745944/"},{"label":"ClinicalTrials.gov: SPLASH (NCT04647526)","url":"https://clinicaltrials.gov/study/NCT04647526"}],"tags":["PSMA","radioligand therapy","prostate cancer","beta emitter","phase 3"],"related":["pluvicto","lu177-psma-it","lu-177"],"indications":["prostate-mcrpc"],"sections":[],"technologies":["radioligand-therapy"],"targets":["psma"],"drugs":[],"companies":["lantheus","point-biopharma","eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["splash"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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.","approvals":[],"mechanismSteps":[],"dosing":{"route":"Intravenous infusion","schedule":"Up to 4 cycles at 6.8 GBq (±10%) per cycle, every 8 weeks (SPLASH trial regimen)","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11745944/"},"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/lu-177-pnt2002/","neighbours":{"drug":[{"id":"lu177-psma-it","kind":"drug","name":"177Lu-PSMA-I&T","route":"/drugs/lu177-psma-it/"},{"id":"pluvicto","kind":"drug","name":"Lutetium-177 vipivotide tetraxetan","route":"/drugs/pluvicto/"}],"isotope":[{"id":"lu-177","kind":"isotope","name":"Lutetium-177","route":"/isotopes/lu-177/"}],"indication":[{"id":"prostate-mcrpc","kind":"indication","name":"Metastatic castration-resistant prostate cancer","route":"/indications/prostate-mcrpc/"}],"technology":[{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"},{"id":"lantheus","kind":"company","name":"Lantheus","route":"/companies/lantheus/"},{"id":"point-biopharma","kind":"company","name":"POINT Biopharma","route":"/companies/point-biopharma/"}],"trial":[{"id":"splash","kind":"trial","name":"SPLASH","route":"/trials/splash/"}]}}