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News & Trends - Pharmaceuticals

Novartis’ radioligand therapy shows ‘remarkable’ results in Australian trial for advanced prostate cancer

Health Industry Hub | September 16, 2024 |

Pharma News: Novartis’ radioligand therapy (RLT), hailed as a game-changer for late-stage prostate cancer, is now showing promise for dramatically improving outcomes in earlier stages of the disease, according to a new Peter Mac-led study.

The TGA approved therapy, Pluvicto (Lutetium-177 PSMA-617 or LuPSMA), has already proven in earlier clinical trials to extend life and enhance quality of life for patients with advanced metastatic prostate cancer, especially those who have exhausted all other treatment options.

For the first time, the UpFrontPSMA study tested this therapy on patients newly diagnosed metastatic prostate cancer. The trial’s “remarkable” results were unveiled at the ESMO (European Society for Medical Oncology) Congress 2024.

Peter MacCallum Cancer Centre was a key player in this Phase II trial, which enrolled 130 participants from 11 hospitals across Australia. Patients received androgen deprivation therapy (ADT) and were then divided into two groups. One group received standard chemotherapy, while the other received chemotherapy combined with LuPSMA.

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“Adding LuPSMA therapy to the standard-of-care approach was seen to dramatically improve responses compared to chemotherapy alone,” said Associate Professor Arun Azad, who presented the results at the ESMO conference in Barcelona.

At the heart of the findings was an undetectable PSA (prostate-specific antigen) at 48 weeks post-treatment – a key marker for prostate cancer.

“This was achieved in 41% of patients who received LuPSMA, compared to just 16% for the standard-of-care,” Associate Professor Azad noted.

He further added, “This is a remarkable result; however, before we can say this should change clinical practice, we need to see it replicated in a larger Phase III trial. Thankfully, a global trial like this is already underway.”

The study also highlighted improvements across multiple measures of progression-free survival (PFS), with adverse events comparable between both treatment groups, mostly related to chemotherapy. However, the therapy remains out of reach for many Australians as it is not currently reimbursed.

The UpFrontPSMA trial was funded by the Prostate Cancer Research Alliance (PCRA), a partnership between Movember and the Australian Government’s Medical Research Future Fund (MRFF), with additional support from Novartis and a grant from the U.S. Department of Defence.

Sam McKeown, Movember’s Director of Prostate Cancer Research, emphasised the importance of such research, saying “We are proud to have supported this study through the Prostate Cancer Research Alliance. With prostate cancer cases projected to double by 2040, research aimed at preventing high-risk prostate cancer from progressing to fatal disease is critical.”

Professor Michael Hofman, who heads the Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) at Peter Mac, added “The exciting results we’ve seen in the UpFrontPSMA trial validate the PCRA’s strategy of supporting high-risk, high-reward clinical trials.”

Support for the trial also came from the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group. ANZUP CEO, Associate Professor Samantha Oakes, said “ANZUP is extremely proud of this world-first study, and the results clearly show that adding LuPSMA to the standard of care is improving the lives of people with advanced metastatic prostate cancer.”

The radioactive isotope at the core of Pluvicto is produced by ANSTO, the Australian Nuclear Science and Technology Organisation, at its nuclear medicine facility in Sydney. ANSTO supplies 80% of Australia’s nuclear medicines, which are critical for diagnosing, staging, and treating various conditions, including cancer.

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