Curasight

The investigator-initiated clinical trial testing ⁶⁸Ga-NOTA-AE105 uPAR-PET/MR in patients with gliomas (most common primary brain cancers), where the oral presentation was reported in 2023, has now been published in the scientific journal EJNMMI Research.

The prospective phase II trial that was carried out at Copenhagen's Rigshospitalet, investigated the prognostic value of uPAR-PET with 68Ga-NOTA-AE105 (uTRACE) in 24 patients with primary gliomas. In addition, the study analysed the proportion of patients that were uPAR-PET positive to estimate the potential number of candidates for future uPAR-targeted radioligand therapy (uTREAT).

Of the 24 patients, 16 (67%) were diagnosed with WHO grade 4 gliomas, 6 (25%) with grade 3, and 2 (8%) with grade 2. Almost all (94%) of the grade 4 gliomas (glioblastomas) were uPAR-PET positive. At median follow up of 18.8 (2.1-45.6) months, 19 patients had disease progression and 14 had died. uPAR expression dichotomized into high and low, revealed significant worse prognosis for the high uPAR group for overall survival (OS) and progression free survival with hazard ratio of 14.3 (95% CI, 1.8-112.3; P=0.011), and hazard ratio of 26.5 (95% CI, 3.3-214.0; P=0.0021), respectively.

The authors conclude that "The majority of glioma patients and almost all with grade 4 gliomas displayed uPAR positive lesions", and that "High uPAR expression is significantly correlated with worse survival outcomes for patients."

The full article is available for free download here: https://rdcu.be/dYyDG

"We are extremely excited about the completed phase II study in brain cancer and its clear results underscores the relevance of both uTRACE and uTREAT in brain cancer and in glioblastoma in particular. Importantly, the finding of 94% of glioblastomas being uPAR positive is encouraging for the broad use of uTREAT in these patients." Said CEO Ulrich Krasilnikoff. "If we add the preclinical data previously reported of high efficacy of uTREAT in human glioblastoma, the supporting evidence is substantial". "With regard to uTRACE, its ability to visualize glioma tumor tissue and to predict both survival and tumor progression, makes it an obvious tool in the management of brain tumors" continued Ulrich Krasilnikoff.

About high grade glioma and glioblastoma

Treatment of glioblastoma presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed annually with the aggressive form, glioblastoma, in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50 % of the patients die within 14 months and after five years from diagnosis only 5 % are still alive.