Prostate cancer study breaks new ground with local biopharma partnership

Pharma News: An Australian biopharma company has made a significant announcement about its collaboration with big pharma. The partnership will see the supply of Telix’s Illuccix (TLX591-CDx) for Bayer’s Phase III ARASTEP study, an essential step towards advancing prostate cancer treatment.

The global study is testing the efficacy of Bayer’s androgen receptor inhibitor (ARi) Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) compared to ADT alone in patients with hormone-sensitive prostate cancer with high-risk biochemical recurrence (BCR).

What makes this study unique is the use of PSMA-PET/CT imaging, which is significantly more sensitive than conventional imaging methods such as CT scans, MRI and bone scans. By using this method, it is hoped that prostate cancer lesions that were previously undetectable can now be identified.

“Many patients with rising PSA levels following surgery or radiation are at an increased risk of developing metastasis. We are optimistic about the potential to help patients at this earlier stage of the disease. Nubeqa has already demonstrated efficacy and safety in non-metastatic castration-resistant prostate cancer (nmCRPC) with the Phase III ARAMIS trial, and in metastatic hormone-sensitive prostate cancer (mHSPC) with the Phase III ARASENS trial,” said Dr Tara Frenkl, Senior Vice President and Head of Oncology Development at Bayer.

The ARASTEP study is expected to enrol 750 participants and focuses on patients with high-risk biochemical recurrence (BCR), defined as rising prostate-specific antigen (PSA) levels with a doubling time of less than 12 months after primary treatment of surgery or radiotherapy.

“We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix’s unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool,” said Telix Chief Medical Officer, Dr Colin Hayward.

Nubeqa is also being investigated in further studies across various stages of prostate cancer, including in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III trial evaluating Nubeqa as an adjuvant treatment for localised prostate cancer with very high risk of recurrence.

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