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OPALESCENCE Trial Published in EJNMMI: Confirms Theranostic Potential of TLX250-CDx in Breast Cancer
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that final positive results from the Phase 2 OPALESCENCE trial[1] of TLX250-CDx (89Zr-girentuximab) in metastatic triple negative breast cancer (mTNBC) have been published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI)[2].
About this update from Telix Pharmaceuticals Limited
[{"type":"text","content":"MELBOURNE, Australia and INDIANAPOLIS, Nov. 12, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that final positive results from the Phase 2 OPALESCENCE trial[1] of TLX250-CDx (89Zr-girentuximab) in metastatic triple negative breast cancer (mTNBC) have been published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI)[2].","length":413,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Telix Pharmaceuticals Limited)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Telix Pharmaceuticals Limited)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":166,"url":"https://media.zenfs.com/en/prnewswire.com/0260c8b822b865d6e9308370c79e16fb"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pLUSkugjGfNA5e2aFU4CYQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTI5MztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/0260c8b822b865d6e9308370c79e16fb","width":400,"height":166}},"href":"https://mma.prnewswire.com/media/1920208/Telix_Main_Logo_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"OPALESCENCE was a prospective, single-center Phase 2 investigator-initiated trial (IIT) conducted at the Institut de Cancérologie de l'Ouest (ICO) in St Herblain, France. The trial evaluated the safety, sensitivity, and diagnostic utility of TLX250-CDx PET/CT[3] imaging in women with mTNBC.","length":295,"tagName":"p"},{"type":"text","content":"The pilot prospective study of twelve (12) patients demonstrated the expression of carbonic anhydrase IX (CAIX) in TNBC and effective tumor targeting with TLX250-CDx:","length":166,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Overall sensitivity was 87.5% with 100% sensitivity for breast, skin, and adrenal gland;","length":88,"tagName":"p"}]},{"val":[{"type":"text","content":"Expression in nodes and bone lesions was 88.0% and 91.9%, respectively;","length":71,"tagName":"p"}]},{"val":[{"type":"text","content":"TLX250-CDx PET/CT detected all brain metastases, confirmed by MRI, whereas FDG PET/CT detected only one-third of brain lesions;","length":132,"tagName":"p"}]},{"val":[{"type":"text","content":"Tumor burden analyzed using total tumor volume (TTV) was equivalent between both PET/CT methods; and","length":100,"tagName":"p"}]},{"val":...