Curium Announces Publication of [18F]DCFPyL Versus [18F]Fluoromethylcholine Results From European Phase III Study (PYTHON Trial)

PARIS, July 21, 2023 (GLOBE NEWSWIRE) — Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [¹⁸F] piflufolastat ([¹⁸F]DCFPyL) versus [¹⁸F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer. The results of the PYTHON trial were published online ahead of print in the European Journal of Nuclear Medicine and Molecular Imaging in June 2023.

Today’s announcement follows the May 2023 recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency to grant a marketing authorization for PYLCLARI^® (piflufolastat (¹⁸F)) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer – based on the Phase III PYTHON clinical trial conducted in Europe and the Phase III OSPREY and CONDOR clinical trials conducted in the U.S.

Dr. Daniela E. Oprea-Lager| Assoc. Professor in Nuclear Medicine, MD PhD, Amsterdam UMC (lead author of the PYTHON Manuscript submitted to the European Journal of Nuclear Medicine and Molecular Imaging) commented: “Adequate restaging of patients with biochemically relapsed prostate cancer is essential for guiding clinicians on how to choose the optimal treatment strategy with the maximum benefit for the patients. PYTHON trial demonstrates the superiority of [¹⁸F]DCFPyL above [¹⁸F]fluoromethylcholine PET/CT paving the way towards individualized therapy.”

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented: “[¹⁸F]fluoromethylcholine has been the current approved and established standard for PET/CT imaging of prostate cancer in Europe, and the publication of this manuscript validates our success in developing new diagnostic imaging solutions – as we continue on our journey to redefine the experience of cancer through our trusted legacy in nuclear medicine.”

In the U.S., piflufolastat (¹⁸F) was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY^® and sold by Lantheus.

The PYTHON publication in European Journal of Nuclear Medicine and Molecular Imaging can be found here.

PYTHON Study
The PYTHON Study (NCT04734184) was a Phase III, European, multicenter, prospective cross-over trial, to evaluate and compare the detection rates, impact on patient management and safety profiles of [¹⁸F]DCFPyL and [¹⁸F]fluoromethylcholine, in patients with first biochemical recurrence after initial definitive therapy with curative intent. This study successfully met the primary endpoint.

About PYLARIFY^® (piflufolastat F 18, also known as [18F]DCFPyL) Injection

PYLARIFY^® (piflufolastat F 18) injection (also known as [18F]DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.^1-6

PYLARIFY is FDA-approved and commercialized in the U.S. by Lantheus. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2019.

About Curium
Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com   

For more information:
Ross Bethell
VP, Head of Global Communications
[email protected]

¹Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689
²Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.
³Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.
⁴Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.
⁵Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290
⁶PYLARIFY^® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company