Lantheus’ Phase 3 SPLASH Trial Results: 177Lu-PNT2002 Shows Promise but May Not Overtake Pluvicto

Trial Results:
The Phase 3 SPLASH trial for 177Lu-PNT2002 in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) demonstrated significant improvement in radiographic progression-free survival (rPFS) compared to the control arm.

ESMO Presentation:
Additional clinical data from the trial were presented at the ESMO Congress 2024, highlighting the efficacy of 177Lu-PNT2002 in mCRPC patients who have progressed on androgen receptor pathway inhibitors (ARPI).

Comparison to Pluvicto:
Analysts suggest that while 177Lu-PNT2002 shows promise, it may not be enough to surpass Pluvicto, indicating a competitive landscape in the treatment of mCRPC.

Safety Profile:
177Lu-PNT2002 demonstrated a favorable safety profile with lower rates of grade ≥3 treatment-emergent adverse events compared to the ARPI arm.

Regulatory Status:
The FDA granted Fast Track designation for 177Lu-PNT2002 in April 2023, aiming to expedite the review process for drugs addressing unmet medical needs.

Commercialization Rights:
Lantheus holds exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2002, licensed from POINT Biopharma (a Lilly company) in December 2022.