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177Lu-PNT2002 met its primary endpoint of radiographic progression-free survival (rPFS) in the pivotal Phase III SPLASH trial (9.5 months vs 6.0 months, HR 0.71), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI). The control arm was an ARPI.
In addition to a significant improvement in efficacy, 177Lu-PNT2002 demonstrated a favorable safety profile with grade ≥3 treatment-emergent adverse events (TEAEs). Notably, the 177Lu-PNT2002 dose is lower than 177Lu-PSMA-617 (Pluvicto) in the Phase III PSMAfore trial, which Novartis presented at ESMO 2023 and also shared in a press release.
| 177Lu-PNT2002 Arm | ARPI Arm | |
| TEAEs of CTCAE Grade ≥3 | 30.1% | 36.9% |
| Serious TEAEs | 17.1% | 23.1% |
| TEAEs Leading to Discontinuation | 1.9% | 6.2% |
In the press release by Lantheus and press release by POINT Biopharma, the companies expect follow-up data in 2024 prior to the potential submission of a New Drug Application (NDA). Overall, the SPLASH study results demonstrate that 177Lu-PNT2002 has the potential to play an important role in addressing an urgent unmet need for patients with mCRPC who have progressed on an ARPI.
