Lantheus and POINT Biopharma Announce Positive Topline Results from Pivotal SPLASH Trial in Metastatic Castration-Resistant Prostate Cancer

Phase 3 SPLASH study of ¹⁷⁷Lu-PNT2002 demonstrated statistically significant improvement in radiographic progression-free survival (rPFS)

BEDFORD, Mass., and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- December 18, 2023 – Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today 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 (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).

“There is an urgent unmet need for targeted treatment options for mCRPC patients, particularly for those whose cancer has progressed on androgen receptor pathway inhibitors,” said Dr. Kim Chi, SPLASH Principal Investigator, Medical Oncologist, BC Cancer. “The SPLASH study results demonstrate that ¹⁷⁷Lu-PNT2002 is well-tolerated and has the potential to play an important role in addressing those needs for patients with chemotherapy-naïve mCRPC.”

The SPLASH trial met its primary endpoint, demonstrating a median radiographic progression-free survival (rPFS) 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 (hazard ratio [HR] 0.71; p=0.0088). 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 prior to 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).

	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%