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Posted 24 April 2024 AM
An Australian trial has shown significant benefits to adding Novartis' Pluvicto to Astellas' Xtandi in treating metastatic castration-resistant prostate cancer, with the authors saying it "has implications for the future use of theranostics in prostate cancer".
Pluvicto is currently being evaluated by the TGA. It has approval in the US for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in patients who have been treated with androgen receptor pathway inhibition, such as Xtandi, and taxane-based chemotherapy.
"This trial raises the question of whether PSMA targeted therapy should be used with an androgen receptor pathway inhibitor to prolong treatment responses," the authors wrote. That could mean Pluvicto will move up a line in treatment in some cases.
The ENZA-p study was led by the ANZUP Cancer Trials Group in partnership with the Prostate Cancer Research Alliance, a joint initiative between the Australian Federal Government and the Movember Foundation, with the results published in The Lancet Oncology.
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| Dramatisation of Pluvicto inside the cell |
It looked at prostate cancer patients with two or more risk factors for early progression, and found that treating with Pluvicto and Xtandi concurrently dramatically improved survival rates.
It found adding Pluvicto to Xtandi "improved prostate-specific antigen (PSA) progression-free survival providing evidence of enhanced anticancer activity in patients with metastatic castration-resistant prostate cancer with risk factors for early progression on Xtandi and warrants further evaluation of the combination more broadly in metastatic prostate cancer".
In the randomised trial patients were split to receive either Xtandi alone or Xtandi plus Pluvicto. The primary endpoint was PSA progression-free survival, and the trial found 93 per cent of patients treated with Xtandi and Pluvicto saw a reduction in PSA of 50 per cent or more, compared to 68 per cent of the Xtandi only group.
The proportion of patients who saw a PSA reduction of 90 per cent or more was also higher in the combination arm with 78 per cent of patients showing this reduction, compared to just 37 per cent in the Xtandi only group.
Median PSA progression-free survival was 13.0 months in the combined arm compared to 7.8 months in the Xtandi group. Restricted mean survival time estimates at 20 months were 13.2 months for those receiving Xtandi and Pluvicto, and 8.5 months for those receiving just Xtandi.
The study did find that adverse events were higher in the combined arm compared to the Xtandi-only arm.
Funding for the trial also came from Novartis subsidiary Endocyte, St Vincent's Clinic Foundation, GenesisCare, and Roy Morgan Research.
James Quintana Pearce
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