Lantheus, Point Biopharma report topline results from Phase 3 SPLASH trial

Lantheus Holdings (LNTH) and POINT Biopharma (PNT) announced statistically significant topline results from the pivotal Phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen-targeted radioligand therapy, in patients with metastatic castration-resistant prostate cancer after progression on an androgen receptor pathway inhibitor. The SPLASH trial met its primary endpoint, demonstrating a median radiographic progression-free survival per blinded independent central review 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 results were immature, the HR was 1.11. The companies expect additional, follow-up data in 2024 prior to the potential submission of a New Drug Application. 177Lu-PNT2002 demonstrated a favorable safety profile with grade greater than or equal to3 treatment-emergent adverse events per Common Terminology Criteria for Adverse Events, serious TEAEs, and TEAEs leading to discontinuation occurring at lower rates in the 177Lu-PNT2002 arm than in the ARPI arm. The open-label study randomized 412 patients with PSMA-expressing mCRPC who had progressed on ARPI therapy and either refused or were not eligible for chemotherapy, in a 2:1 randomization ratio. At the time of the analysis, 84.6% of patients who experienced progressive disease in the control arm subsequently crossed over to receive 177Lu-PNT2002. SPLASH was conducted across the United States, Canada, Europe, and the United Kingdom. Eighty percent of SPLASH patients resided in North America and approximately 10% of all participants were Black or African American.