Telix Pharmaceuticals and the Oncidium foundation announced the publication of interim results from the NOBLE (Nobody Left Behind) Registry in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) Reports, highlighting the potential of TLX599-CDx (99mTc-iPSMA) in improving access to prostate cancer imaging. The global real-world evidence (RWE) study demonstrated that TLX599-CDx, an investigational prostate cancer imaging agent, effectively identifies PSMA-positive prostate cancer using widely available SPECT cameras.
The NOBLE registry is a collaborative effort combining the Oncidium foundation's oncology and prostate cancer expertise, Telix's intellectual property, and partnered clinical and operational support. The study aims to address the disparity in access to state-of-the-art prostate cancer imaging, particularly in regions with limited resources.
Interim Results Show Promise
The published interim results are based on a study of 40 patients across six countries who received TLX599-CDx followed by planar and SPECT imaging. The investigators reported a change in management for 17 patients (42.5%) due to the use of SPECT-based PSMA imaging. Importantly, no adverse events were reported during the study.
According to the publication, TLX599-CDx SPECT imaging detected at least one PSMA-positive lesion in 77.5% of patients. When stratified by prostate-specific antigen (PSA) levels, the detection rate for [99mTc]Tc-HYNIC-iPSMA was 16.6% at PSAs of 0-2 ng/mL, 83.3% at PSAs of > 2–10 ng/mL, and 89.2% at PSAs of greater than 10 ng/mL.
Addressing Unmet Needs with SPECT Imaging
SPECT cameras are more widely available than the PET/CT scanners typically used for gallium- or fluorine-based PSMA imaging. Globally, there are four times as many SPECT machines as PET scanners, making SPECT a more accessible option, especially when used with 99mTc, a radionuclide with a well-established supply chain that can be produced in a bench-top generator.
Pete Tually, lead author and Director of TeleMed Remote Nuclear Medicine, emphasized the importance of the NOBLE Registry in increasing access to medicine globally, particularly for men in regional and remote locations. He stated that the interim results provide a compelling basis for further clinical study of technetium-99m-based PSMA imaging of prostate cancer.
Future Directions for NOBLE
Telix and the Oncidium foundation are planning follow-on clinical activity for NOBLE, potentially including collaboration with Rhine Pharma on expanded access or compassionate use programs. They are also exploring the use of technetium-99m and rhenium-188 as a theranostic pair for prostate cancer. This initiative reflects Telix's global commitment to access to medicine.
