Prostate cancer trial stuns researchers: 'It's a once in a career feeling'

Johnson & Johnson's Zytiga helps men newly diagnosed with advanced prostate cancer live longer, according to new findings that could expand use of the medication.

Offering a drug up-front with standard hormone treatment extends survival in men whose prostate cancer has spread, according to results from a late stage clinical trial.

J&J $JNJ has been duking it out with Pfizer's Xtandi - recently acquired in the $14 billion Medivation deal - in the area of prostate cancer, where both drugs are credited with a major improvement in the standard of care for prostate cancer.

Previous results from the trial have already changed clinical practice - data released past year has led to docetaxel chemotherapy now being part of the standard of care for many men with prostate cancer. "I really hope these results can change clinical practice".

Additional study results found abiraterone acetate plus prednisone, in combination with ADT, decreased the risk of progression or death rPFS by 53 percent compared to placebo plus ADT in patients with mHNPC (HR=0.47%, 95% CI [0.39 to 0.55], P 0.0001).

At a median of 30 months after beginning treatment, men taking Zytiga and the steroid prednisone plus standard hormonal therapy had a 38 percent lower risk of death compared with men given hormone therapy and a placebo.

"We think this is one of the biggest survival gains ever reported in a trial in adults with solid tumor", he said.

Abiraterone could now become a first-line treatment alongside ADT for men with advanced prostate cancer. The combination arm experienced significant benefit with treatment compared with the ADT-alone arm (3-year overall survival 83% vs 76%; 3-year failure-free survival 75% vs 45%; and 3-year progression-free survival 80% vs 62%). The findings suggest that the drug, now used to treat men who worsen after getting standard hormone therapy, shouldn't be withheld until the cancer starts to spread. The doctors explained that surgery wasn't an option for me because the cancer had spread beyond my prostate.

According to the investigators, adverse events were consistent with experience for castration-resistant prostate cancer.

A patient named Alfred Samuels, 59, was diagnosed with advanced prostate cancer in January 2012 and joined the STAMPEDE trial in March.

"There is a large unmet need to improve treatment for men with newly diagnosed metastatic cancer, who die of the disease within less than five years on average", said lead study author Karim Fizazi head of the Department of Cancer Medicine at Gustave Roussy, University Paris-Sud in Villejuif, France.

The studies, published in the New England Journal of Medicine, were funded by J&J. Professor James added: "We are so incredibly thankful to the patients and clinical staff who have agreed to take part in this study".

"The time for which the cancer remained under control was more than twice as long for men receiving abiraterone", said Jones.

Experts said results of the study were "exciting" and "promising" after patients who had exhausted all other treatment options showed an impressive response.

The conference also heard about a new drug that dramatically reduces ovarian tumours.

Fizazi said a trial to see if Zytiga has a benefit when added to hormone therapy and chemotherapy is still under way.

Workman added that the drug is a highly innovative treatment that not only improves survival rates but has lower rates of side-effects, compared to conventional therapies.

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