NEW YORK–(BUSINESS WIRE)–Oct 20, 2018–Pfizer Inc.(NYSE:PFE) today appear abundant all-embracing adaptation (OS) abstracts from the PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in aggregate with fulvestrant compared to placebo added fulvestrant in women with hormone receptor-positive (HR ), animal epidermal beforehand agency receptor 2-negative (HER2-) metastatic blight whose ache progressed on or afterwards above-mentioned endocrine therapy. In the study, there was a afterwards beforehand in OS of about seven months with IBRANCE added fulvestrant compared to placebo added fulvestrant, although this aberration did not adeptness the prespecified alpha for statistical acceptation (median OS: 34.9 months [95% CI: 28.8, 40.0] against 28.0 months [95% CI: 23.6, 34.6]; HR=0.81 [95% CI: 0.64, 1.03], 1-sided p=0.0429). These abstracts will be presented as a late-breaking articulate abstruse during the Presidential Symposium at the ESMO 2018 Congress (European Society for Medical Oncology) in Munich, Germany, and accompanying appear in The New England Journal of Medicine.
The aberration in average OS accustomed in this assay (6.9 months) is constant with the beforehand ahead accustomed for the primary endpoint of average progression-free adaptation (mPFS). In the adapted PFS assay for this abstraction (non-prespecified), the aggregate of IBRANCE added fulvestrant showed a statistically cogent and clinically allusive 6.6-month mPFS beforehand compared to placebo added fulvestrant (11.2 vs. 4.6 months; HR=0.50 [95% CI: 0.40-0.62], p<0.000001). 1 All-embracing adaptation is a accessory endpoint of PALOMA-3, and the balloon architecture was not optimized to ascertain a statistically cogent aberration in OS.
“It’s noteworthy that the consequence of progression-free adaptation account empiric in PALOMA-3 has translated to a agnate aberration of about seven months in all-embracing survival, which is clinically meaningful. This is decidedly cogent accustomed the challenges of demonstrating all-embracing adaptation in this ache setting, breadth post-progression assay is generally essentially best than time on study,” said Massimo Cristofanilli, M.D., accessory administrator for Translational Analysis at the Robert H. Lurie Comprehensive Blight Center of Northwestern University, as able-bodied as arch investigator of the PALOMA-3 trial. “The all-embracing adaptation data, accompanying with the ahead accustomed progression-free adaptation benefit, are auspicious for patients.”
At the time of this analysis, aftereffect was 44.8 months and about 60 percent (n=310) of contest had occurred in the 521 patients enrolled. Patients on both accoutrements accustomed up to 10 curve (range 1-10) of post-progression treatment.
The trend against OS benign the IBRANCE added fulvestrant arm was empiric beyond best subgroups, with hazard ratios constant with the all-embracing population. In addition, for the all-embracing population, the aberration in OS was associated with abiding time from randomization to aboriginal use of chemotherapy post-progression, an basic endpoint (HR=0.58 [95% CI: 0.47, 0.73], 1-sided p<0.000001). Average time to chemotherapy was 17.6 months (95% CI: 15.2, 19.7) for patients who accustomed IBRANCE added fulvestrant, alert that empiric in patients who accustomed placebo added fulvestrant (8.8 months [95% CI: 7.3, 12.7]).
“Delaying the charge for chemotherapy is a axial ambition of assay for women with this disease. These new abstracts from PALOMA-3 appearance that abacus IBRANCE to fulvestrant led to a abundant beforehand in this important area,” said Nicholas Turner, M.D., Ph.D., assistant of atomic oncology at The Institute of Blight Research, London, and adviser medical oncologist at The Royal Marsden NHS Foundation Trust, as able-bodied as arch investigator of the PALOMA-3 trial. “The aberration in all-embracing adaptation and abiding time to chemotherapy accustomed in PALOMA-3 added abutment the role of IBRANCE in aggregate with endocrine assay as a accepted of affliction in HR , HER2- metastatic cancer.”
“Looking at the abstracts from the PALOMA-3 balloon and beyond the PALOMA program, IBRANCE has adapted the assay mural for this disease,” said Mace Rothenberg, M.D., arch development officer, Oncology, Pfizer All-around Product Development. “We are appreciative of the acute anatomy of affirmation acknowledging the use of IBRANCE in this setting, and the aberration this anesthetic continues to accomplish in the lives of patients.”
The best accepted adverse reactions in PALOMA-3 included neutropenia, leukopenia, infections, fatigue and nausea. No new assurance signals empiric with best aftereffect were articular as allotment of this final OS analysis.
About IBRANCE® (palbociclib) 125 mg capsules
IBRANCE is an articulate inhibitor of CDKs 4 and 6, 2 which are key regulators of the corpuscle aeon that activate cellular progression. 3,4 In the U.S., IBRANCE is adumbrated for the assay of HR , HER2- avant-garde or metastatic blight in aggregate with an aromatase inhibitor as antecedent endocrine based assay in postmenopausal women, or fulvestrant in women with ache progression afterward endocrine therapy.
IBRANCE currently is accustomed in added than 85 countries and has been assigned to added than 160,000 patients globally.
The abounding prescribing advice for IBRANCE can be begin at www.pfizer.com.
IMPORTANT IBRANCE®(palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
Neutropenia was the best frequently appear adverse acknowledgment in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Brand 3 (56%) or 4 (10%) decreased neutrophil counts were appear in patients accepting IBRANCE added letrozole. In PALOMA-3, Brand 3 (55%) or Brand 4 (11%) decreased neutrophil counts were appear in patients accepting IBRANCE added fulvestrant. Febrile neutropenia has been appear in 1.8% of patients apparent to IBRANCE beyond PALOMA-2 and PALOMA-3. One afterlife due to neutropenic sepsis was empiric in PALOMA-3. Acquaint patients to promptly address any fever.
Monitor complete claret calculation above-mentioned to starting IBRANCE, at the alpha of anniversary cycle, on Day 15 of aboriginal 2 cycles and as clinically indicated. Dosage interruption, dosage reduction, or adjournment in starting assay cycles is recommended for patients who beforehand Brand 3 or 4 neutropenia.
Based on the apparatus of action, IBRANCE can account fetal harm. Advise females of changeable abeyant to use able contraception during IBRANCE assay and for at atomic 3 weeks afterwards the aftermost dose. IBRANCE may blemish abundance in males and has the abeyant to account genotoxicity. Advise macho patients with changeable ally of changeable abeyant to use able contraception during IBRANCE assay and for 3 months afterwards the aftermost dose. Advise females to acquaint their healthcare provider of a accepted or doubtable pregnancy. Advise women not to feed during IBRANCE assay and for 3 weeks afterwards the aftermost dosage because of the abeyant for austere adverse reactions in nursing infants.
The best accepted adverse reactions(≥10%) of any brand appear in PALOMA-2 for IBRANCE added letrozole vs placebo added letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), abhorrence (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), adventurous (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), airsickness (16% vs 17%), decreased appetence (15% vs 9%), dry bark (12% vs 6%), agitation (12% vs 9%), and dysgeusia (10% vs 5%).
The best frequently appear Brand ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE added letrozole vs placebo added letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).
Lab abnormalities of any brand occurring in PALOMA-2 for IBRANCE added letrozole vs placebo added letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), added aspartate aminotransferase (52% vs 34%), and added alanine aminotransferase (43% vs 30%).
The best accepted adverse reactions (≥10%) of any brand appear in PALOMA-3 for IBRANCE added fulvestrant vs placebo added fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), abhorrence (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), airsickness (19% vs 15%), alopecia (18% vs 6%), adventurous (17% vs 6%), decreased appetence (16% vs 8%), and agitation (13% vs 5%).
The best frequently appear Brand ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE added fulvestrant vs placebo added fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%).
Lab abnormalities of any brand occurring in PALOMA-3 for IBRANCE added fulvestrant vs placebo added fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), added aspartate aminotransferase (43% vs 48%), and added alanine aminotransferase (36% vs 34%).
Avoid circumstantial use of able CYP3A inhibitors. If patients charge be administered a able CYP3A inhibitor, abate the IBRANCE dosage to 75 mg. If the able inhibitor is discontinued, admission the IBRANCE dosage (after 3-5 half-lives of the inhibitor) to the dosage acclimated above-mentioned to the admission of the able CYP3A inhibitor. Grapefruit or grapefruit abstract may admission claret concentrations of IBRANCE and should be avoided. Avoid accessory use of able CYP3A inducers. The dosage of acute CYP3A substrates with a attenuated ameliorative basis may charge to be bargain as IBRANCE may admission their exposure.
For patients with astringent hepatic crime (Child-Pugh chic C), the recommended dosage of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE accept not been advised in patients acute hemodialysis.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we accept we can accomplish a allusive aberration on the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 12 accustomed blight medicines beyond 20 indications, including , prostate, kidney, lung and hematology. We additionally accept one of the centermost oncology biosimilars pipelines, with two medicines accustomed globally and several assets in mid to late-stage development for the assay of blight or as admiring care. Pfizer Oncology is appetite to change the aisle of cancer.
Working calm for a convalescent world®
At Pfizer, we administer science and our all-around assets to accompany therapies to bodies that extend and decidedly beforehand their lives. We strive to set the accepted for quality, assurance and amount in the discovery, development and accomplish of bloom affliction products. Our all-around portfolio includes medicines and vaccines as able-bodied as abounding of the world’s best-known customer bloom affliction products. Every day, Pfizer colleagues assignment beyond developed and arising markets to beforehand wellness, prevention, treatments and cures that claiming the best feared diseases of our time. Constant with our albatross as one of the world’s arch avant-garde biopharmaceutical companies, we coact with bloom affliction providers, governments and bounded communities to abutment and aggrandize admission to reliable, affordable bloom affliction about the world. For added than 150 years, we accept formed to accomplish a aberration for all who await on us. We commonly column advice that may be important to investors on our website at www.pfizer.com. In addition, to apprentice more, amuse appointment us on www.pfizer.com and chase us on Twitter at @Pfizer and @Pfizer—News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The advice independent in this absolution is as of October 20, 2018. Pfizer assumes no obligation to amend advanced statements independent in this absolution as the aftereffect of new advice or approaching contest or developments.
This absolution contains advanced advice about IBRANCE (palbociclib), including its abeyant benefits, that involves abundant risks and uncertainties that could account absolute after-effects to alter materially from those bidding or adumbrated by such statements. Risks and uncertainties include, amid added things, uncertainties apropos the bartering success of IBRANCE; the uncertainties inherent in analysis and development, including the adeptness to accommodated advancing analytic balloon admission and achievement dates and authoritative acquiescence dates, as able-bodied as the achievability of abortive analytic balloon results, including abortive new analytic abstracts and added analyses of absolute analytic data; whether authoritative authorities will be annoyed with the architecture of and after-effects from our analytic studies; whether and back biologic applications may be filed in any added jurisdictions for IBRANCE for abeyant HR /HER2- metastatic blight break or in any jurisdictions for any added abeyant break for IBRANCE; whether and back any such added applications may be accustomed by authoritative authorities, which will depend on the appraisal by such authoritative authorities of the benefit-risk contour appropriate by the accumulation of the ability and assurance advice submitted; decisions by authoritative authorities apropos labeling and added affairs that could affect the availability or bartering abeyant of IBRANCE; and aggressive developments.
A added description of risks and uncertainties can be begin in Pfizer’s Annual Address on Form 10-K for the budgetary year concluded December 31, 2017 and in its consecutive letters on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Advice and Factors That May Affect Approaching Results,” as able-bodied as in its consecutive letters on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and accessible atwww.sec.govandwww.pfizer.com.
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SOURCE: Pfizer Inc.
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PUB: 10/20/2018 10:30 AM/DISC: 10/20/2018 10:30 AM
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