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Clinical Trials

Apalutamide delays spread of several prostate cancers in phase 3 trial

PBR Staff Writer Published 12 February 2018

A group of investigators have demonstrated in a phase 3 clinical trial that apalutamide, an inhibitor of androgen receptor, delays spread of certain prostate cancers that had become resistant to standard androgen-deprivation therapy.

The placebo-controlled trial was held in over 1,200 men with nonmetastatic, castration-resistant prostate cancer, who were at high risk for the development of metastasis in spite of being under conventional hormone therapy.

Led by scientists from Massachusetts General Hospital (MGH) and University of California, San Francisco (UCSF), the trial showed that apalutamide had cut down the risk of either the spread of the cancer or death by more than 70%.

As per the trial findings published in the New England Journal of Medicine (NEJM), patients subjected to apalutamide (240mg per day) survived without their cancer spreading for more than three years on average in comparison to 16.2 months for those in the placebo arm.

Matthew Smith of MGH Cancer Center, who had been a corresponding author of the NEJM report, said: “Our study found that apalutamide treatment markedly improved metastasis-free survival and other clinical outcomes in men with castration-resistant prostate cancers and no detectable metastases.

“At this time, there are no approved treatments for men in that situation, so we need to wait until their disease progresses to add the standard therapies that have been approved for metastatic disease.”

In addition to extending survival in the patients, apalutamide was also found to have alleviated other signs of disease progression in comparison to placebo.

UCSF Helen Diller Family Comprehensive Cancer Center deputy director Eric Small said: “This trial’s results suggest that the availability of apalutamide should offer men with nonmetastatic, castration-resistant prostate cancer a treatment that can delay or prevent the development of metastases and other complications associated with disease progression.”

Apalutamide, which is being developed by Janssen Pharmaceutical, binds to the androgen receptor and thereby prevents its activation by testosterone and other androgens to slow down the growth of the cancer cells.

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a marketing authorisation application to the European Medicines Agency for apalutamide to treat patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).


Image: Eric Small presented data from the phase 3 trial of apalutamide at the ASCO-GU Symposium. Photo: courtesy of The Regents of the University of California.