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Astellas, Medivation prostate cancer drug beats expectations in phase III

Results come as Astellas records net income increase of 24 per cent in the fiscal third quarter

Top-line results from a phase III trial of Astellas and Medivation's prostate cancer drug MDV3100 indicate that it can extend survival by almost five months in men who have already received chemotherapy for the disease.

The first-in-class androgen receptor signalling inhibitor (ARSI) met all primary and secondary endpoints in the AFFIRM study and demonstrated a favourable safety profile, according to Howard Scher of the MD Anderson Cancer Centre in the US, one of the trial's principal investigators.

AFFIRM was stopped early in November 2011 after an independent data monitoring committee concluded that MDV3100 was exerting a clinically meaningful and significant survival advantage over placebo.

Follow-up results released yesterday indicate that this survival advantage is sustained, while a number of secondary endpoints reinforce the main findings.

The study enrolled men whose cancer was progressing despite prior treatment with docetaxel, a standard chemotherapy regimen for the disease. The patients were randomised to MDV3100 - given as a once-daily oral dose - or placebo.

Men treated with MDV3100 lived for a median of 18.4 months, compared to 13.6 months for those on placebo.

Radiographic progression-free survival was extended from 2.9 to 8.3 months, and 28.9 per cent of the MDV3100 group exhibited a soft tissue response, compared to just 3.8 per cent of the placebo group.

Using prostate-specific antigen (PSA) as a biomarker, the investigators were also able to show greater declines with Astellas and Medivation's drug, and a greater time before PSA levels started to climb again (8.3  compared to 3 months).

The data are due to be presented at the 2012 Genitourinary Cancer Symposium in San Francisco tomorrow.

Medivation and Astellas are carrying out three additional studies of MDV3100 to explore its role in prostate cancer treatment further.

The phase III PREVAIL and phase II TERRAIN studies are looking at the drug's use in men who have received hormonal therapy, but not chemotherapy for the disease. A phase II trial is also ongoing in men who have not yet been treated with hormonal drugs.

Astellas reports buoyant sales growth

News of the positive AFFIRM results came just ahead of the publication of Astellas' fiscal third-quarter results, which included a 24 per cent increase in net income on sales up 4 per cent at 764bn yen ($10bn) in the first nine months of the year.

Astellas said growth was driven by Vesicare (solifenacin succinate) for overactive bladder and lung cancer drug Tarceva (erlotinib), while immunosuppressant Prograf (tacrolimus) for benign prostatic hyperplasia decreased thanks to generic competition.

1st February 2012

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