Log in
E-mail
Password
Show password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. Japan
  4. Japan Exchange
  5. Astellas Pharma Inc.
  6. News
  7. Summary
    4503   JP3942400007

ASTELLAS PHARMA INC.

(4503)
  Report
SummaryChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

Astellas Pharma : ' and Pfizer's XTANDI® (enzalutamide) Reduced Risk of Death by 34% in Men with Metastatic Hormone-Sensitive Prostate Cancer in Phase 3 ARCHES Study

09/20/2021 | 07:42pm EDT

Late-breaking abstract to be presented September 18 during European Society for Medical Oncology Congress 2021

TOKYO and NEW YORK, September 17, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) announced today ahead of the European Society for Medical Oncology (ESMO) Congress 2021 that XTANDI® (enzalutamide) improved overall survival (OS) in the ARCHES study in men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer). The Phase 3, randomized, double-blind, placebo-controlled trial compared XTANDI plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with mHSPC and OS was a key secondary endpoint.

In the study, XTANDI plus ADT reduced the risk of death by 34% (n=1,150; hazard ratio [HR]=0.66; [95% confidence interval [CI]: 0.53-0.81]; p<0.0001) compared to placebo plus ADT. Median OS, which represents the time from randomization to death due to any cause, was not reached in either treatment group. The safety profile in both study arms was consistent with findings from the primary analysis.

Results from the final analysis of the ARCHES trial will be presented virtually at ESMO by Andrew Armstrong, M.D., Professor of Medicine, Surgery, Pharmacology and Cancer Biology, and Director of Research in the Duke Cancer Institute's Center for Prostate and Urologic Cancers in Durham, North Carolina, U.S. (Abstract LBA25; September 18, 14:20 CEST).

"Overall survival benefit has been observed in patients treated with enzalutamide in three stages of advanced prostate cancer - metastatic castration-resistant prostate cancer, non-metastatic castration-resistant prostate cancer, and now in metastatic hormone-sensitive prostate cancer," said Dr. Armstrong. "The results from ARCHES provide valuable data on the clinical profile of enzalutamide in this earlier disease setting."

The primary results from the ARCHES trial were published in the Journal of Clinical Oncology in 2019. The study met its primary endpoint of radiographic progression-free survival (rPFS) as assessed by independent central review, finding that treatment with XTANDI plus ADT demonstrated a 61% reduction in the risk of radiographic disease progression or death compared with ADT alone in men with mHSPC (HR=0.39; [95% CI: 0.30-0.50]; p<0.001). The median follow-up time was 14.4 months. Median rPFS was not reached (NR) with XTANDI plus ADT (95% CI: NR to NR) versus 19.0 months (95% CI: 16.6-22.2 months) with placebo plus ADT. At the time of the primary analysis, OS data were not mature.

In the ARCHES primary analysis, Grade 3 or greater adverse events (AEs; defined as severe/disabling or life-threatening) were similar for patients receiving both XTANDI plus ADT and those who received placebo plus ADT (24.3% vs. 25.6%). Common AEs (occurring in at least 5% of patients) that were reported more often in patients treated with XTANDI plus ADT versus those treated with ADT alone included hot flush, fatigue, arthralgia, hypertension, nausea, musculoskeletal pain, diarrhea, asthenia and dizziness.

These data supported global regulatory approvals, including European Commission marketing authorization for mHSPC earlier this year.

Click below for a copy of the full press release

Disclaimer

Astellas Pharma Inc. published this content on 21 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 September 2021 23:41:08 UTC.


© Publicnow 2021
All news about ASTELLAS PHARMA INC.
10/19ASTELLAS PHARMA : Receives “2021 Award for Excellence in Corporate Disclosure”..
PU
10/13Astellas and Seagen Complete Enrollment in EV-103 Trial Cohort K Combining PADCEV (enfo..
AQ
10/12ASTELLAS PHARMA : and Seagen Complete Enrollment in EV-103 Trial Cohort K Combining PADCEV..
PU
10/12SEAGEN : Astellas Complete Enrollment in Cohort K of Study of Padcev, Keytruda Combination..
MT
10/12ASTELLAS PHARMA : Seagen and Astellas Complete Enrollment in EV-103 Trial Cohort K Combini..
BU
10/11ASTELLAS PHARMA : World's First Use of Environmentally Friendly Biomass-based Plastic for ..
PU
10/05PRESS RELEASE : MIG Fonds leads EUR65 million Series B financing of iOmx Therapeutics
DJ
10/05PRESS RELEASE : iOmx Therapeutics raises EUR 65 million in Series B round
DJ
10/04PRESS RELEASE : MIG sells portfolio company Hemovent to MicroPort
DJ
10/01ASTELLAS PHARMA : Juntendo University and Astellas Establish "Direct Reprogramming Regener..
PU
More news
Financials
Sales 2022 1 327 B 11 677 M 11 677 M
Net income 2022 196 B 1 722 M 1 722 M
Net cash 2022 584 B 5 138 M 5 138 M
P/E ratio 2022 18,4x
Yield 2022 2,55%
Capitalization 3 627 B 31 899 M 31 928 M
EV / Sales 2022 2,29x
EV / Sales 2023 2,05x
Nbr of Employees 15 455
Free-Float 98,9%
Chart ASTELLAS PHARMA INC.
Duration : Period :
Astellas Pharma Inc. Technical Analysis Chart | 4503 | JP3942400007 | MarketScreener
Technical analysis trends ASTELLAS PHARMA INC.
Short TermMid-TermLong Term
TrendsBullishNeutralBullish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 13
Last Close Price 1 957,50 JPY
Average target price 2 462,50 JPY
Spread / Average Target 25,8%
EPS Revisions
Managers and Directors
Kenji Yasukawa President, CEO & Representative Director
Naoki Okamura CFO, Representative Director & Vice President
Yoshihiko Hatanaka Chairman
Yoshitsugu Shitaka Chief Scientific Officer
Fumiaki Sakurai Head-Business Administration & Compliance
Sector and Competitors
1st jan.Capi. (M$)
ASTELLAS PHARMA INC.22.80%31 899
JOHNSON & JOHNSON4.03%430 990
ROCHE HOLDING AG15.15%337 974
NOVO NORDISK A/S58.77%242 392
PFIZER, INC.17.25%241 985
ELI LILLY AND COMPANY44.37%220 979