Lantheus Presents Results from the Primary Analysis of Phase 3 Pivotal SPLASH Trial in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer During ESMO Congress 2024

Study met its primary endpoint, demonstrating significant improvement in radiographic progression-free survival

Overall Response Rate was 38.1% vs. 12.0% for the ARPI switch arm, including 9.3% Complete Responses

Patients demonstrated statistically significant improvement in time to reduction of health-related quality of life (HRQoL) as measured by Functional Assessment of Cancer Therapy—Prostate (FACT-P)

Interim Overall Survival Crossover Adjusted Hazard Ratio was <1.00 when Assessed Using Two-Stage and Inverse Probability Censoring Weighting Methods

Overall Survival data continue to mature, an update is expected once data are available for 75% of protocol-specified target OS events

BEDFORD, Mass., Sept. 15, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, presented additional clinical data from initial topline results of the SPLASH Phase 3 trial evaluating the efficacy of ¹⁷⁷Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), administered at 6.8 GBq every 8 weeks for up to 4 cycles in patients with metastatic castration-resistant prostate cancer (mCRPC) following progression on androgen receptor pathway inhibitor (ARPI). Data were presented during the European Society of Medical Oncology (ESMO) Congress 2024, which is taking place in Barcelona, Spain.

“We are encouraged by the initial results from the SPLASH trial, with ¹⁷⁷Lu-PNT2002 demonstrating improvement compared to ARPI change in radiographic progression-free survival, positive interim crossover-adjusted overall survival hazard ratios, as well as improved quality of life,” said Oliver Sartor, M.D., Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic in Rochester, Minnesota. “These initial data underscore the importance of PSMA-targeted RLTs, including ¹⁷⁷Lu-PNT2002, as potential treatment options for patients who have limited choices after progressing on ARPI therapy.”

Efficacy Endpoint		177Lu-PNT2002 vs. ARPI
Radiographic Progression-Free Survival (rPFS)		HR 0.71 (CI: 0.55, 0.92; p=0.0088)
Median rPFS		9.5 vs. 6.0 months
OS HR (46% of protocol-specified target OS events reached)		1.11 (0.73, 1.69; p=0.6154)
OS HR crossover adjusted: prespecified RPSFTM*		1.14 (0.54, 2.53)
Two-Stage Method: no recensoring**		0.68 (0.44, 1.04)
Two-Stage Method: recensoring**