Medivation Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) appear final after-effects on the primary and accessory ability endpoints from the Phase 3 PREVAIL balloon of enzalutamide in patients with chemotherapy-naïve metastatic prostate blight who accept bootless androgen denial assay and accept few or no symptoms. Abstracts will be aggregate in a late-breaking articulate presentation at the accessible American Society of Analytic Oncology (ASCO) 2014 Genitourinary (GU) Cancers Symposium in San Francisco on Thursday, January 30, 2014.
“The PREVAIL abstraction after-effects authenticate for the aboriginal time a statistically cogent abridgement both in the accident of afterlife and a adjournment in blight progression in men with metastatic prostate blight who accept a ascent PSA and few, if any, symptoms.” said Tomasz M. Beer, M.D., F.A.C.P., assistant of anesthetic and agent administrator of the Knight Blight Institute at Oregon Bloom & Science University, and co-principal investigator of the PREVAIL study. “The ambit of the ability endpoints and the assurance contour in PREVAIL, including the breadth of time that chemotherapy can be delayed, would represent a footfall advanced for men with prostate cancer.”
The PREVAIL abstraction after-effects in men with metastatic prostate blight who accept progressed on androgen denial assay are as follows:
Treatment with enzalutamide accustomed a statistically cogent all-embracing adaptation account compared with placebo treatment. Enzalutamide bargain the accident of afterlife by 29% (HR=0.71; p < 0.0001), compared with placebo. This account was empiric admitting abundant use of consecutive therapies (40% in the enzalutamide and 70% in the placebo groups).
Assay with enzalutamide decidedly bargain the accident of radiographic progression or afterlife by 81% compared with placebo assay (HR=0.19; p < 0.0001).
Consistent allowances on these co-primary endpoints of all-embracing adaptation and radiographic progression-free adaptation were empiric beyond accommodating subgroups.
Men demography enzalutamide accomplished a 17-month adjournment in the time to admission of chemotherapy compared with men demography placebo (28.0 months adjoin 10.8 months; HR=0.35; p < 0.0001).
The majority of men (58.8%) with bendable tissue metastatic ache brash with enzalutamide adjoin 5% of patients brash with placebo had cold responses (complete responses or fractional responses) including complete responses in 19.7% of enzalutamide patients compared with 1% of placebo patients.
Enzalutamide connected the average time to PSA progression from 2.8 months (placebo) to 11.2 months (HR= 0.169; p < 0.0001).
Nearly 4 out of 5 patients in the enzalutamide accumulation accomplished a PSA abatement of 50% or more, compared to beneath than 4% in the placebo accumulation (78% vs. 3.5%; p < 0.0001).
The average times to abasement in a admeasurement of prostate cancer-specific affection of life, the Functional Assessment of Blight Therapy-Prostate or FACT-P, were 11.3 months for the enzalutamide-treated patients and 5.6 months for the placebo patients (HR=0.625, p < 0.0001).
The average assay continuance for enzalutamide was added than 3 times best than for placebo (16.6 adjoin 4.6 months).
Accepted ancillary furnishings occurring during assay and added accepted in the enzalutamide brash men included fatigue, aback pain, ache and arthralgia. Hypertension was empiric in 13.4% of enzalutamide adjoin 4.1% of placebo-treated patients. Grade 3 or college cardiac adverse contest were appear in 2.8% of enzalutamide adjoin 2.1% of placebo-treated patients. Investigators appear aught seizures in the enzalutamide-treated accumulation and one in the placebo accumulation above-mentioned to the abstracts blow date. One access was appear in the enzalutamide accumulation afterwards the abstracts blow date.
“Medivation’s primary mission is to beforehand and accomplish accessible to patients medically avant-garde therapies that accommodate clinically allusive allowances and abode above medical unmet needs amid a spectrum of austere diseases,” said David Hung, M.D., founder, admiral and CEO of Medivation. “Should enzalutamide be accustomed for use in this accommodating population, it will be a allusive beforehand in the acreage of prostate blight therapy.”
“The PREVAIL abstraction after-effects are auspicious and we plan to submit, forth with our accomplice Medivation, our authoritative applications to the U.S. Food and Biologic Administration and European Medicines Agency in aboriginal 2014,” said Sef Kurstjens, M.D., Ph.D., and Chief Medical Officer of Astellas. “Astellas is committed to actuality a all-around class baton in the action adjoin blight by accouterment patients with assay options, such as enzalutamide, to administer their disease.”
Details of the presentation are as follows:
Title: Enzalutamide in men with chemotherapy-naïve metastatic prostate blight (mCRPC): After-effects of Phase 3 PREVAIL Abstraction
Presenter: Tomasz M. Beer, M.D., F.A.C.P., Knight Blight Institute, Oregon Bloom & Science University
Session Detail: Welcome and General Session 1: Integrating Androgen Axis Assay beyond the Ache Spectrum Session Date/Time: January 30, 2014 from 7:45 a.m – 9:45 a.m. About the PREVAIL Balloon
The Phase 3 PREVAIL balloon is a randomized, double-blind, placebo-controlled, multi-national balloon that enrolled added than 1,700 patients at sites in the United States, Canada, Europe, Australia, Russia, Israel and Asian countries including Japan. The balloon enrolled patients with metastatic prostate blight whose ache progressed admitting assay with androgen denial assay and had not yet accustomed chemotherapy. The co-primary endpoints of the balloon were all-embracing adaptation and radiographic progression-free survival. The balloon was brash to appraise enzalutamide at a dosage of 160 mg taken orally already circadian adjoin placebo. Targeted acceptance was completed in May 2012 and the pre-specified acting assay was conducted afterwards 516 contest (patient deaths).
Enzalutamide Apparatus of Action
Enzalutamide is an androgen receptor inhibitor that acts on altered accomplish in the androgen receptor signaling pathway. Enzalutamide has been apparent to competitively arrest androgen bounden to androgen receptors, and arrest androgen receptor nuclear about-face and alternation with DNA.
About XTANDI® (enzalutamide) capsules
XTANDI was accustomed by the FDA on August 31, 2012 and is adumbrated for the assay of patients with metastatic castration-resistant prostate blight (mCRPC) who accept ahead accustomed docetaxel.
Important Assurance Admonition for XTANDI (from the accustomed prescribing information)
Contraindications – XTANDI can account fetal abuse aback administered to a abundant woman based on its apparatus of action. XTANDI is not adumbrated for use in women. XTANDI is contraindicated in women who are or may become pregnant.
Warnings and Precautions – In the randomized analytic trial, access occurred in 0.9% of patients on XTANDI. No patients on the placebo arm accomplished seizure. Patients experiencing a access were assuredly discontinued from therapy. All seizures resolved. Patients with a history of seizure, demography medications accepted to abatement the access threshold, or with added accident factors for access were afar from the analytic trial. Because of the accident of access associated with XTANDI use, patients should be brash of the accident of agreeable in any action area abrupt accident of alertness could account austere abuse to themselves or others.
Adverse Reactions – The best accepted adverse biologic reactions (≥ 5%) appear in patients accepting XTANDI in the randomized analytic balloon were asthenia/fatigue, aback pain, diarrhea, arthralgia, hot flush, borderline edema, musculoskeletal pain, headache, high respiratory infection, able-bodied weakness, dizziness, insomnia, lower respiratory infection, analgesic bond compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and in 6% on placebo (no Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients and 2% on placebo. One percent of XTANDI patients compared to 0.3% on placebo died from infections or sepsis. Avalanche or injuries accompanying to avalanche occurred in 4.6% of XTANDI patients adjoin 1.3% on placebo. Avalanche were not associated with accident of alertness or seizure. Fall-related injuries were added astringent in XTANDI patients and included non-pathologic fractures, collective injuries, and hematomas. Grade 1 or 2 hallucinations occurred in 1.6% of XTANDI patients and 0.3% on placebo, with the majority on opioid-containing medications at the time of the event.
Drug Interactions – Effect of Added Drugs on XTANDI: Administration of able CYP2C8 inhibitors can access the claret acknowledgment to XTANDI. Co-administration of XTANDI with able CYP2C8 inhibitors should be abhorred if possible. If co-administration of XTANDI cannot be avoided, abate the dosage of XTANDI. Co-administration of XTANDI with able or abstinent CYP3A4 and CYP2C8 inducers can adapt the claret acknowledgment of XTANDI and should be abhorred if possible.
Effect of XTANDI on Added Drugs: XTANDI is a able CYP3A4 inducer and a abstinent CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4, CYP2C9 and CYP2C19 substrates with a attenuated ameliorative index, as XTANDI may abatement the claret exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct added INR monitoring.
For Full Prescribing Admonition for XTANDI (enzalutamide) capsules, amuse appointment www.XtandiHCP.com.
Medivation, Inc. is a biopharmaceutical aggregation focused on the accelerated development of atypical baby atom drugs to amusement austere diseases for which there are bound assay options. Medivation aims to transform the assay of these diseases and action accomplishment to alarmingly ill patients and their families. For added information, amuse appointment us at www.medivation.com.
About Astellas Pharma Inc.
Astellas Pharma Inc. is a biologic aggregation committed to convalescent the bloom of bodies about the apple through accouterment of avant-garde and reliable pharmaceuticals. The alignment is committed to actuality a all-around class baton in Oncology and Urology, and has several oncology compounds in development in accession to enzalutamide. For added admonition on Astellas Pharma Inc., amuse appointment our website at www.astellas.com/en.
Note Apropos Forward-Looking Statement – Medivation
This columnist absolution contains advanced statements, including statements apropos the connected analytic development of enzalutamide and abeyant approaching advance accompanying thereto, our strategy, and the connected capability of, and continuing collaborative activities and allowances under, Medivation’s accord acceding with Astellas, which are fabricated pursuant to the safe anchorage accoutrement of the Private Securities Litigation Reform Act of 1995. Any statements independent in this columnist absolution that are not statements of absolute actuality may be accounted to be advanced statements. Advanced statements absorb risks and uncertainties that could account Medivation’s absolute after-effects to alter decidedly from those projected, including, after limitation, risks accompanying to the timing and abeyant authoritative approval and commercialization of enzalutamide, the progress, timing and after-effects of Medivation’s analytic trials, including the accident that adverse analytic balloon after-effects could abandoned or calm with added factors aftereffect in the adjournment or cessation of some or all of Medivation’s artefact development activities, the accident that absolute after-effects apparent in our analytic trials may not be predictive of the after-effects of our advancing or planned analytic trials and the accident that life-prolonging treatments could anticipate advancing or planned enzalutamide trials from afterwards or could abate any abeyant adaptation account that may be apparent in these trials alike if they do succeed, difficulties or delays in enrolling and application patients in Medivation’s analytic trials, including as a aftereffect of the availability of aggressive treatments or analytic trials of aggressive drugs for the aforementioned indication, Medivation’s assurance on the efforts of and allotment by Astellas for the development of enzalutamide, the accomplishment of development, authoritative and bartering milestones beneath Medivation’s accord acceding with Astellas, the accomplishment of Medivation’s artefact candidates, the industry and aggressive market, the capability of Medivation’s banking resources, hasty expenditures or liabilities, Medivation’s outstanding convertible chief notes, bookish acreage matters, and added risks abundant in Medivation’s filings with the Securities and Exchange Commission, including its annual address on Form 10-Q for the division concluded September 30, 2013, filed on November 12, 2013 with the SEC. You are cautioned not to abode disproportionate assurance on the advanced statements, which allege alone as of the date of this release. Medivation disclaims any obligation or adventure to amend or alter any advanced statements independent in this columnist release.
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