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 Seagen Complete Enrollment in EV-103 Trial Cohort K Combining PADCEV« (enfortumab vedotin-ejfv) with Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer

10/12/2021 | 07:42pm EST

TOKYO and BOTHELL, Wash. - October 12, 2021 - Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) today announced that patient enrollment was completed in Cohort K of the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869). The cohort is evaluating PADCEV® (enfortumab vedotin-ejfv) in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. Merck is known as MSD outside the United States and Canada.

"Completing enrollment in this study is an important step in investigating the potential for the combination of PADCEV and KEYTRUDA to treat metastatic urothelial cancer," said Roger Dansey, M.D., Chief Medical Officer, Seagen. "If results of this study are compelling, we may have the opportunity to submit them to the FDA as part of an application for accelerated approval."

EV-103 is a multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive bladder cancer and in locally advanced or metastatic urothelial cancer in first- or second-line settings. Key outcome measures of EV-103 Cohort K are objective response rate (ORR) per blinded independent central review (BICR) using RECIST 1.1 and duration of response (DoR). The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation in February 2020 for PADCEV in combination with KEYTRUDA for patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. The designation is based on results from the dose-escalation cohort and expansion cohort A of the EV-103 trial.

"The FDA's Breakthrough Therapy designation is based on preliminary data on the combination of PADCEV and KEYTRUDA," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "Both Cohort K of EV-103 and our ongoing, broader phase 3 EV-302 study are evaluating this platinum-free combination in patients with previously untreated advanced urothelial cancers." EV-302 is also known as KEYNOTE-A39.

Click below for a copy of the full press release

Disclaimer

Astellas Pharma Inc. published this content on 13 October 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 October 2021 23:41:01 UTC.


ę Publicnow 2021
All news about ASTELLAS PHARMA INC.
11/26ASTELLAS PHARMA : Annual Report 2021 is now available.
PU
11/25ASTELLAS PHARMA : Pivotal Phase 3 Trial for Pediatric Praziquantel Completes with Positive..
PU
11/19ASTELLAS PHARMA : ' Efforts Against the Spread of the Coronavirus Disease (COVID-19)
PU
11/14ASTELLAS PHARMA : and Pantherna Enter into Technology Evaluation Agreement for Research of..
PU
11/12PLAUSIBILITY AND UNDUE BURDEN : A New Look Insufficiency After FibroGen v Akebia
AQ
11/02Earnings call script
PU
10/28Supplementary Documents (Q2/FY2021)
PU
10/28Financial Results (Q2/FY2021)
PU
10/28Presentation Material for Information Meeting (Q2/FY2021)
PU
10/28Astellas Pharma Inc. Revises Consolidated Earnings Guidance for the Full Year Ending Ma..
CI
More news
Financials
Sales 2022 1 327 B 11 693 M 11 693 M
Net income 2022 184 B 1 621 M 1 621 M
Net cash 2022 393 B 3 462 M 3 462 M
P/E ratio 2022 18,9x
Yield 2022 2,64%
Capitalization 3 507 B 30 934 M 30 907 M
EV / Sales 2022 2,35x
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
TrendsBearishNeutralNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 13
Last Close Price 1 892,50 JPY
Average target price 2 466,67 JPY
Spread / Average Target 30,3%
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.18.73%30 914
JOHNSON & JOHNSON1.82%421 847
ROCHE HOLDING AG17.17%334 769
PFIZER, INC.38.25%285 639
NOVO NORDISK A/S68.76%247 704
ELI LILLY AND COMPANY55.18%237 527