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Lantheus’ PYLARIFY AI Platform Demonstrates Higher Efficiency and Consistency While Maintaining Accuracy for Assessment of PSMA Imaging in Prostate Cancer

Study Results Presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Vancouver

Lantheus Holdings, Inc. (“the Company”) is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. Lantheus presented study results providing independent validation of PYLARIFY AI, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. The results were presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting and demonstrated the higher efficiency and consistency of the PYLARIFY AI platform while maintaining the diagnostic accuracy of PSMA imaging in prostate cancer.

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“This independent evaluation of PYLARIFY AI in the CONDOR study has demonstrated its ability for rapid lesion detection and reproducible quantitative assessment, while maintaining the diagnostic accuracy for PSMA PET imaging. Further validation is warranted to understand the utility of PYLARIFY AI in prognosis and treatment response with PSMA PET imaging,” commented Jeremie Calais, MD, MSc, Assistant Professor, Department of Molecular and Medical Pharmacology, Director, UCLA Theranostics Program, Ahmanson Translational Theranostics Division, University of California, Los Angeles (UCLA), who presented the study. “The widespread availability of PSMA PET imaging has revolutionized our ability to see metastases in the body and more accurately stage prostate cancer. Additionally, used as a whole-body imaging biomarker, it can provide guidance on therapeutic response before initiation of PSMA-targeted therapies. Whole-body quantitative parameters extracted from an AI platform can further enhance our knowledge in developing individualized, precision medicine for prostate cancer patients.”

As part of the study, researchers set out to evaluate PYLARIFY AI against manual reads by blinded independent readers who analyzed the 208 patients with biochemical recurrent prostate cancer enrolled in the Phase 3 CONDOR study.1 A total of 323 lesions were identified by Standard of Truth (SOT). In the sensitivity analysis against SOT, one reader demonstrated significant improvement of lesion detection with PYLARIFY AI compared to manual reads. In the other two readers, there was moderate improvement observed compared to manual reads.

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Median reading times for reader one, two and three were 1.4 minutes, 1.2 minutes, and 1.4 minutes, respectively. The interquartile range of all reading times combined was 2.1 minutes. The reproducibility of per-lesion standard uptake value (SUV) measurements among the three readers was significantly higher with PYLARIFY AI (ICC 0.98 95% CI 0.96 to 0.99) than without (ICC 0.90 95% CI 0.88 to 0.91) p<0.0001.

“Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform the way that clinicians manage and treat prostate cancer,” said Jean-Claude Provost, MD, Interim Chief Medical Officer, Lantheus. “Previous studies have shown how this technology can have utility as a complementary diagnostic tool, and with these results we continue to demonstrate PYLARIFY AI’s reliability, its ability to improve workflow and how it can be applied to our mission to Find, Fight and Follow prostate cancer to improve patient outcomes.”

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