Gozetotide is a drug for diagnostic software in adults with prostate most cancers. It’s presently the one diagnostic agent that acknowledges PSMA-positive prostate most cancers and may due to this fact determine sufferers for whom PSMA-targeted remedy with (177Lu)lutetium vipivotide tetraxetan (“Lutetium-177” for brief) is an possibility.
In an early profit evaluation, the Institute for High quality and Effectivity in Well being Care (IQWiG) has now investigated whether or not gozetotide (probably with subsequent lutetium-177 remedy) presents an additional advantage for males with metastatic, castration-resistant prostate most cancers over individualized remedy with out dedication of the PSMA standing (and due to this fact with out using PSMA-targeted remedy).
A examine for the evaluation of the diagnostic and therapeutic brokers
The abbreviation PSMA stands for prostate-specific membrane antigen: a protein that may happen in elevated quantities on most cancers cells. Lutetium-177 is a radioactive substance that binds to PSMA and may thus irradiate the most cancers cells in a focused method. The purpose is to decelerate most cancers development and alleviate signs. Gozetotide is used for diagnostics previous to remedy with lutetium-177. Gozetotide additionally binds to the most cancers cells that carry PSMA on their floor. It’s radioactively labelled and thus visualizes the most cancers cells throughout a PET scan.
The health-related advantages or harms of diagnostic assessments are primarily solely realized by means of the following therapeutic or preventive procedures. Gozetotide is the one accredited diagnostic agent for the detection of PSMA-positive modifications in sufferers with prostate most cancers. Due to this fact, it doesn’t substitute some other check, however acknowledges a brand new sort of illness (PSMA-positive prostate most cancers) for which an efficient remedy is obtainable (Lutetium-177). By linking diagnostics and remedy, the identical VISION examine can be utilized for the early profit evaluation of the diagnostic agent gozetotide as for the prevailing one of many therapeutic agent lutetium-177. The pharmaceutical firm’s up to date search confirmed that, regardless of the time lag between the VISION examine and the profit evaluation of the therapeutic agent lutetium-177, no additional proof on gozetotide (adopted by lutetium-177) is presently accessible along with the VISION examine.
Statements on additional advantage solely potential for sure sufferers
The VISION examine is an unblinded, randomized managed trial with an enrichment design that included 831 males with PSMA-positive prostate most cancers, every after PSMA diagnostics with gozetotide. All sufferers within the VISION examine obtained hormone blockade and individually tailored remedy. 551 males have been moreover handled with lutetium-177. The androgen receptor pathway inhibitors enzalutamide and abiraterone have been, amongst different medication, administered as individually tailored remedy; cabazitaxel and olaparib weren’t permitted. Thus, the comparator therapies used within the examine didn’t cowl all remedy choices accessible for individualized remedy within the therapeutic indication. Consequently, the VISION examine solely permits conclusions on the additional advantage of gozetotide in these sufferers for whom abiraterone together with prednisone or prednisolone, enzalutamide or greatest supportive care is probably the most appropriate individualized remedy.
The examine suggests a bonus for Lutetium-177 after PSMA diagnostics with gozetotide, significantly when it comes to general survival. Moreover, there have been additionally constructive results for the examine outcomes “spinal twine compression” and “want for radiotherapy for alleviation of bone ache”. Though extreme unintended effects equivalent to myelosuppression additionally occurred, these don’t name into query the advantages for sufferers.
General, the evaluation end result corresponds to the early profit evaluation of lutetium-177 from July 2023: There’s a main added advantage of gozetotide over the suitable remedy for sufferers for whom abiraterone (with prednisone or prednisolone), enzalutamide or greatest supportive care is the very best remedy. The additional advantage is just not confirmed in sufferers for whom cabazitaxel or olaparib is your best option, as these therapies weren’t permitted within the examine.
The G-BA decides on the extent of additional advantage
The file evaluation is a part of the early profit evaluation in response to the Act on the Reform of the Marketplace for Medicinal Merchandise (AMNOG) supervised by the G-BA. After publication of the file evaluation, the G-BA conducts a commenting process and makes a last resolution on the extent of the additional advantage.