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    Medivation Phase 3 Results for enzalutamide in Metastatic Hormone Sensitive Prostate Cancer

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    Biotech Forecast
    Clinical and Regulatory
    Event Type: Phase 3 Results
    Timing: Q4 2016
    Designation(s): None

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Oncology
    Indication: Metastatic Hormone Sensitive Prostate Cancer
    Lead Indication?: No
    Treatment Name: XTANDI (enzalutamide)

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Medivation
    Stock Symbol: MDVN
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Ongoing
    Event Discussion: Forums
    Event Announcement(s): http://investors.medivation.com/releasedetail.cfm?ReleaseID=962052
    Partnership: Yes

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement

    Quote

    TOKYO and SAN FRANCISCO, March 24, 2016 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (NASDAQ: MDVN) today announced that the ARCHES (AR Inhibition with ChemoHormonal Therapy in Men with MEtastatic Castrate Sensitive Prostate Cancer) Phase III registrational trial, which will evaluate the efficacy and safety of enzalutamide with androgen deprivation therapy (ADT) versus placebo with ADT in metastatic hormone sensitive prostate cancer (mHSPC) patients, has been initiated and the first patient has been randomized.

    Quote

    The global, Phase III, randomized, double-blind, placebo-controlled study, which is being led by Astellas, will evaluate the efficacy and safety of enzalutamide with ADT versus placebo with ADT in patients with mHSPC. ARCHES will enroll approximately 1,100 patients with mHSPC at approximately 250 centers globally. The primary endpoint of the trial is radiographic progression-free survival (rPFS), defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review or death, whichever occurs first. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily versus placebo, administered with ADT.    

     

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    There is a high likelihood Xtandi will be approved given it is already approved for use in prostrate cancer.

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