Lantheus Holdings Inc LNTH and POINT Biopharma Global Inc PNT reported topline data from pivotal Phase 3 SPLASH trial of 177Lu-PNT2002 in metastatic castration-resistant prostate cancer after progression on an androgen receptor pathway inhibitor (ARPI).
177Lu-PNT2002 is a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT).
The SPLASH trial met its primary endpoint, demonstrating a median radiographic progression-free survival (rPFS) of 9.5 months for patients treated with 177Lu-PNT2002, compared to 6.0 months for patients treated with ARPI in the control arm, a statistically significant 29% reduction in the risk of radiographic progression or death.
At the time of the analysis, interim overall survival (OS) results were immature (46% of protocol-specified target OS events reached), the HR was 1.11.
The companies expect additional follow-up data in 2024 before the potential submission of a New Drug Application (NDA).
177Lu-PNT2002 demonstrated a favorable safety profile with grade ≥3 treatment-emergent adverse events (TEAEs) per Common Terminology Criteria for Adverse Events (CTCAE), serious TEAEs, and TEAEs leading to discontinuation occurring at lower rates in the 177Lu-PNT2002 arm than in the ARPI arm (30.1%, 17.1%, and 1.9% vs. 36.9%, 23.1%, and 6.2%, respectively).
Price Action: LNTH shares are down 23.05% at $58.51, and PNT stock is down 11.13% at $12.46 on the last check Monday.
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