In SPLASH, a second PSMA radioligand improved progression-free survival but not, so far, survival.
SPLASH, trial NCT04647526 sponsored by Lantheus through POINT Biopharma and reported in 2024, tested a second PSMA radioligand, 177Lu-PNT2002, also known as 177Lu-PSMA-I&T, against a switch of androgen receptor pathway inhibitor in PSMA-positive, taxane-naive metastatic castration-resistant prostate cancer. It randomised 412 men and met its primary radiographic progression-free survival endpoint, but the interim overall survival analysis was numerically unfavourable, with 46 percent of events and 84 percent crossover, and Lantheus deprioritised a US filing pending mature data. OnCo links it to prostate cancer and to the 177Lu-PSMA-I&T drug record; its effect was smaller than PSMAfore's with a different ligand and dosing, while ECLIPSE with the same ligand met its progression endpoint. Whether crossover masked a real benefit or the drug simply adds little is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
455 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survivalprimary | 177Lu-PNT2002 (PSMA-I&T) | 276 | 9.5 months | 0.71 (0.55 to 0.92) | 0.0088 | link |
| ARPI switch | 136 | 6 months | ||||
| Overall survival (interim) | 177Lu-PNT2002 | - | Numerically unfavourable at interim with crossover | 1.11 | - | link |
| ARPI switch | - | - |
Shares 177Lu-PSMA-I&T, Radioligand therapy (beta emitters), Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares 177Lu-PSMA-I&T, Radioligand therapy (beta emitters), Prostate cancer.
Shares Lantheus, Prostate cancer.
Shares Lantheus, Prostate cancer.
Shares Radioligand therapy (beta emitters), Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares Radioligand therapy (beta emitters), Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares Metastatic castration-resistant prostate cancer, Prostate cancer.