British regulators have given the nod to a prostate cancer drug that can delay the progression of the disease in terminal patients for more than a year, and will give hope to thousands of men with advanced metastatic cancer, which does not respond to the main forms of treatment.
The drug, Pluvicto, has been approved by the Medicines and Healthcare Products Regulatory Agency, and cancer experts have called it a “major clinical advance” that could now be rolled out in the NHS before the end of 2022, reports The Independent.
More than 50 000 men in the UK alone are diagnosed with prostate cancer each year, making it the most common form of cancer in men, with more than 12 000 annual deaths from the illness.
More than three quarters (78%) of them survive for more than 10 years, but this proportion has barely changed over the past decade in the UK, largely because the disease is typically detected at a relatively late stage.
Trials involving the drug found it could delay disease progression by 12.5 months on average, with a four-month improvement on overall survival compared with traditional treatments.
Six months after treatment, 65% of patients given the drug, made by Novartis, had no worsening of the disease, compared with 28% of those given radiation therapy and hormone treatments.
It specifically targets cancer cells by seeking out a protein called prostate-specific membrane antigen, or PSMA, which is present in high levels on the surface of cancer cells but not on healthy ones. When the drug makes contact, it delivers a precisely targeted dose of radiation to kill the cancer cells.
Men with higher levels of PSMA on their tumours are most likely to benefit from the targeted drug.
Institute of Cancer Research scientists led on research which found that patients could be selected for the treatment using a test identifying patients with genetic faults in DNA repair genes, and also showing that DNA damage increases PSMA levels on the surface of prostate cancer cells. The amount of PSMA on the surface of cancer cells was four times higher in patients with faults in these DNA repair genes – testing for these faults could indicate patients most likely to benefit from the drug.
Steve Allen, acting chair of the Tackle Prostate Cancer patient organisation, said the approval was “another positive milestone for eligible patients and their families”.
“Far too many people are still dying each year from prostate cancer. Tragically, those diagnosed with metastatic prostate cancer will only have about a one in two chance of surviving for five years,” he said.
“There continues to be a real and pressing need for better treatments for people with advanced prostate cancer. This new approach is very welcome.”
Professor Johann de Bono, professor of experimental cancer medicine at the Institute of Cancer Research in London and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, said: “This is a major clinical advancement for people with advanced prostate cancer who have recurrent disease after androgen receptor pathway inhibitors and chemotherapy.
“Results from the Phase III Vision study have shown the significance of this precision medicine for patients with advanced prostate cancer, and it is encouraging to see such innovations being recognised by the MHRA with this licensing authorisation.”
The move comes as scientists argued that public health messaging around prostate cancer might be hampering efforts at early detection by placing a misleading focus on urinary symptoms.
Study details
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION)
Published on Clinical Trials. gov on 9 August 2022
Brief Summary
The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone.
Clinical trials information (Open access)
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