EXINI Diagnostics AB, a Lantheus Company, Receives CE Marking Authorization for aPROMISE in Europe
NORTH BILLERICA, Massachusetts – (COMMERCIAL THREAD) – EXINI Diagnostics AB, a subsidiary of Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapies and artificial intelligence solutions ( IA) to Find, Combat and Track Serious Medical Conditions, today announced that it has received CE marking authorization for aPROMISE in Europe.
aPROMISE is an artificial intelligence-based, deep learning-based medical device software that enables healthcare professionals and researchers to perform a quantitative PET / CT assessment of the specific membrane antigen of the prostate (PSMA) in oncology. aPROMISE includes a solution for automated body segmentation and marking, quantification and reporting of suspicious lesions in their anatomical context.1.2 The AI tool provides increased consistency in quantitative analysis and is intended to increase the efficiency, accuracy and reproducibility of PSMA PET / CT image evaluations.
In a prospectively planned independent review of the PyL OSPREY trial, aPROMISE demonstrated high reproducibility with an intraclass correlation coefficient (ICC) of 0.99 (95% CI 0.99 – 0.99). In patients with metastatic prostate cancer, the sensitivity of aPROMISE in a preselection of lesions was 92% for regional lymph nodes, 91% for distant lymph nodes and 87% for bone.
“The Standardized Molecular Imaging Imaging Criteria for Prostate Cancer (PROMISE) have proposed a consistent language for objective reporting to help physicians assess a patient’s tumor burden and also provide clinically relevant information. meaningful to physicians in developing treatment plans, ”said Matthias Eiber, Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany. “With the introduction of PROMISE criteria automation, the software is able to facilitate adherence to standardized reports in clinical practice by reducing reporting time and the limitations of manual assessment. ”
“The aPROMISE CE mark approval is an exciting step for Lantheus on the path to eventual approval in the United States later this year,” said Etienne Montagut, senior vice president, business development. “We believe that PROMISE is a unique offering that could complement and strengthen our portfolio of PSMA assets by improving their value and ease of use while helping treating clinicians in their patient management decisions. ”
About prostate cancer
Prostate cancer is the second most common form of cancer in men in the United States – an estimated one in eight men will be diagnosed with prostate cancer in their lifetime. The American Cancer Society estimates that by 2021, 248,530 new cases of prostate cancer will be diagnosed and that 34,130 men will die from the disease. About 3.1 million men in the United States currently consider themselves to be prostate cancer survivors.3
PyL (also known as 18F-DCFPyL) is a PSMA-targeted fluorinated PET imaging agent that visualizes prostate cancer localized both localized and metastatic to lymph nodes, bone and soft tissue for detect and locate recurrent prostate and / or metastatic cancer. On September 29, 2020, Lantheus submitted a New Drug Application (NDA) for PyL which was accepted and obtained priority review and assigned an action date under the Drug User Fees Act on ordinance (PDUFA) as of May 28, 2021.
Phase 2/3 OSPREY trial
The OSPREY trial was designed to assess the diagnostic performance of PyL for detecting prostate cancer in pelvic lymph nodes in subjects with high risk prostate cancer (cohort A) and confirm distant metastasis in subjects with metastatic or recurrent prostate cancer (cohort B). The primary endpoints of the trial were the sensitivity and specificity of PET / CT PyL imaging to detect metastatic prostate cancer in pelvic lymph nodes versus histopathology in cohort A. A criterion Key secondary assessment of the trial was the sensitivity of PET / CT PyL imaging to detect prostate cancer at sites of metastasis or local recurrence compared to histopathology in cohort B.
In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (cohort A) was compared with histopathology. PyL showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% meeting specificity but not the predetermined primary endpoint of sensitivity. In the context of metastatic or recurrent prostate cancer (cohort B), PyL exhibited a sensitivity of 93-99% and a PPV of 81-88% to detect metastatic lesions. Overall, PyL has demonstrated high diagnostic performance in the reliable detection of distant lymph node and metastatic prostate cancer.
The safety results showed that PyL was well tolerated. The most frequently reported adverse events were dysgeusia (2.6%), headache (1.8%) and fatigue (1.3%).
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated supplier of innovative imaging diagnostics, targeted therapies and solutions for artificial intelligence to find, fight and track® serious medical conditions. Lantheus offers a wide range of products, including the echocardiography agent DEFINITY® Vial for suspension for injection (Perflutren lipid microspheres); Technelite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, in partnership with Bausch Health Companies, Inc. The company is headquartered in North Billerica, Massachusetts, with offices in New York, New Jersey, Canada and Sweden. For more information, please visit www.lantheus.com.
Safe Harbor for forward-looking statements and cautions
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which are subject to risks and uncertainties and are made in accordance with the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by the use of terms such as “believe”, “could”, “expect”, “intend”, “possible”, “propose”, “may” and d ‘other similar terms. These forward-looking statements are based on current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to differ materially from those described in forward-looking statements. The inclusion of forward-looking statements should not be taken as a representation that these plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on any forward-looking statements contained in this document, which speak only as of the date hereof. The Company assumes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. Risks and uncertainties that could cause our actual results to differ materially from those described in forward-looking statements include (i) a delay in obtaining or failure to obtain a positive regulatory result from the FDA and ‘other regulatory authorities for PyL or aPROMISE; (ii) the Company’s ability to successfully launch aPROMISE as a commercial product; (iii) market responsiveness to the use of medical device software based on artificial intelligence and based on deep learning; (iv) protection of the intellectual property of aPROMISE; and (v) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section of our annual reports on Form 10-K and our quarterly reports on Form 10-Q) .
1 Complete detection and quantification through deep learning of 18FDCFPyL PET / CT (PyL-PSMA). Brynolfsson J, Johnsson K, Sahlstedt H, Richter J, et al, OP-548, 1006: Cutting-edge scientific suite – TROP session: IA -Radiomics and modeling, EANM 2020.
2 MiPSMA Index: Complete and automated quantification of PET / CT 18F-DCFPyL (PyL-PSMA) for prostate cancer staging. Johnsson K, Sahlstedt H, Brynolfsson J, et al. J Nucl Med. 2020; 61 (1): 1435
3 American Cancer Society. Facts and Figures 2021. American Cancer Society. Atlanta, Georgia. 2021.