Log in
Forgot password ?
Become a member for free
Sign up
Sign up
Dynamic quotes 

4-Traders Homepage  >  Equities  >  Nasdaq  >  Amgen    AMGN

Mes dernières consult.
Most popular
News SummaryMost relevantAll newsSector newsTweets

Amgen : Phase 3 Study Confirms Clinical Equivalence for ABP 980 and Reference Trastuzumab

share with twitter share with LinkedIn share with facebook
share via e-mail
10/05/2017 | 06:15pm CET

Following the previous release of top-line results, complete phase 3 data show that a biosimilar almost beat reference trastuzumab (Herceptin) for the primary endpoint of pathologic complete response (pCR). Detailed findings from the phase 3 trial with the proposed biosimilar, ABP 980, were presented at the 2017 annual meeting of the European Society for Medical Oncology (ESMO) in Madrid, Spain.

In the head-to-head trial, Lilac, the relative advantage of the biosimilar for the primary endpoint of pathologic complete response (pCR) reached statistical significance on local (but not on central) review, reported Serafin Morales, MD, a coauthor of the study and medical oncologist at the University Hospital Arnau de Vilanova, Lledia, Spain. However, a demonstration of superiority was not the goal of the trial. The key study conclusion is, says Dr. Morales, that ABP 980 and trastuzumab show great biosimilarity.

The phase 3 study was the last step in testing ABP 980 after extensive laboratory and early clinical phase studies confirmed similar pharmacokinetics and biologic activity. In this double-blind, multicenter study, 725 women with HER2-positive early breast cancer were randomized to receive ABP 980 or the reference trastuzumab. After 4 cycles of chemotherapy (epirubicin and cyclophosphamide), patients received a neoadjuvant course of their assigned therapy along with paclitaxel for 4 cycles.

After surgery, patients received ABP 980 or reference trastuzumab every 3 weeks for up to 1 year, but the efficacy analysis was conducted from tissue collected at surgery. The studys primary endpoints were risk differences (RD) and risk ratio (RR) of pCR in breast tissue and axillary lymph nodes by local laboratory and central pathology evaluation. Secondary endpoints were incidence of treatment-emergent adverse events, changes in left ventricular ejection fraction (LVEF), incidence of anti-drug antibodies (ADSs), and on-study event-free survival (EFS).

The proportion of patients who received all 4 doses of their assigned neoadjuvant therapy was similar, reaching 98.1% for ABP 980 and 97.5% for reference trastuzumab. The weight-based cumulative dose of the 2 drugs was identical at 25.8 mg/kg.

By local review, the primary pCR endpoint was achieved in 48.0% of those randomized to ABP 980 versus 40.5% of those randomized to reference trastuzumab. The advantage for the biosimilar exceeded the prespecified 13% margin for bioequivalence by RD. While the lower boundary of the 95% confidence interval (CI) for RD exceeded 0% (1.2%), the upper boundary surpassed 13% (13.4%), which met the criterion of a significant advantage. The RR on local review analysis showed the same result.

However, the prespecified margins were not exceeded in the central review. Although the median relative RD was greater for ABP 980 than for reference trastuzumab (5.8%), the margins were below 0% (0.5%) and below 13% (12%). The central review of the RR margins also fell short of statistical significance.

Richard Markus, MD, PhD, vice president for global development at Amgen, said We cannot absolutely conclude that ABP 980 is not superior. However, he emphasized that superiority was not a study hypothesis, and that the most prudent summary from the data is that there is no clinically meaningful difference.

The safety profile also supports equivalence. When adverse events (AE) were compared collectively and individually, the rates were similar for ABP 980 and reference trastuzumab over the course of neoadjuvant treatment. This included, respectively, any treatment-emergent AE (80.2%, 79.5%), any grade 3 or higher treatment-emergent AE (14.8%, 14.1%), and any treatment-emergent AE leading to discontinuation (0.8%, 0.6%).

There was a higher rate of serious treatment-emergent AEs in the ABP 980 group than in the reference trastuzumab group (4.9%, 1.4%), but there was no difference in the pattern of individuals AEs. The most common AEs for ABP 980 and reference trastuzumab, respectively, were peripheral neuropathy (13.7%, 11.9%), arthralgia (17.3%, 15.2%), asthenia (14.8%, 16.3%), alopecia (5.2%, 6.4%), nausea (6.3%, 5.3%), and bone pain (3.3%, 8.0%) The most common grade 3 or higher AE was neutropenia (8.6%, 8.0%). No other grade 3 or higher event occurred in more than 2% of patients. The proportion of patients with a 10% of greater decline in LVEF was uncommon and similar for ABP 980 and reference trastuzumab (0.3%, 0.9%, respectively).

The emergence of anti-drug antibodies was also uncommon in the 2 study arms, occurring in 0.6% of those randomized to ABP 980 and 1.4% of those randomized to reference trastuzumab.

A review of 11 trastuzumab studies published since 2007 in similar study populations produced a range in pCR rates from a low of approximately 30% to a high of nearly 60%, but most fell between 45% and 55%. The average was about 48%, which is consistent with the result of this study, according to Dr. Morales, who concluded that the data add to the totality of evidence demonstrating similarity between ABP 980 and trastuzumab.

ABP 980 is part of a larger biosimilar program being pursued by Amgen and Allergan. Earlier this year, the FDA ODAC unanimously recommended FDA approval of ABP 215, a biosimilar to bevacizumab (Avastin), which was later approved. Most of the other monoclonal antibody biosimilars in development are for indications outside oncology, but a biosimilar to rituximab (Rituxan), ABP 798, is being developed for treatment of both hematological malignancies and non-oncologic applications.

Biosimilars are going to be a tremendous option for patients who have limited access to biologics, said Dr. Markus, who emphasized that Amgen has devoted a significant financial investment in bringing these products forward.

Dr. Markus also emphasized that no two biosimilars are the same, and as a result, Stakeholders need to consider the reliability of the biosimilar as well as the price. Both the FDA and the European Medicines Agency have established criteria for the designation of a biosimilar, but he emphasized that Biologics are complex drugs. We think that consistent quality in the manufacturing network will also be an important variable for clinical benefit, Dr. Markus said.

(c) 2017 Gulf Sports Media All rights reserved. Provided by SyndiGate Media Inc. (Syndigate.info)., source Middle East & North African Newspapers

share with twitter share with LinkedIn share with facebook
share via e-mail
Latest news on AMGEN
02/16NOVARTIS : readies to auction U.S. generic pills business - sources
02/15AMGEN : Results From Phase 3 XGEVA® Denosumab Study In Patients With Multiple My..
02/15AMGEN : Researchers at Amgen Have Reported New Data on Oligopeptides (Rapid scre..
02/14AMGEN : Announces FDA Advisory Committee Meeting To Review Potential New Use Of ..
02/14+50% CAGR TO BE ACHIEVED BY BIOSIMIL : Global Biosimilars Market – Know In..
02/14GLOBAL EYE CANCER MARKET REPORT WITH : Global Eye Cancer Market - Global Industr..
02/14AMGEN : ex-dividend day
02/12AMGEN : Today’s Research Reports on Trending Tickers: Amgen and Celgene
02/12American College of Rheumatology recommends biosimilars for rheumatic disease
02/09Teva falls on Celltrion warning letter, guidance
More news
News from SeekingAlpha
08:00a3 THINGS IN BIOTECH YOU SHOULD LEARN : February 17, 2018 
02/15FDA issues draft industry guidance for early-stage Alzheimer's disease 
02/14FDA Ad Com March 7 for IV administration claim for Amgen's Blincyto 
02/13NASDAQ 'Safer' Dividend Gainers Led By Lam, Western, Broadcom & Vodafone, Per.. 
02/13Western Digital Gain And Vodafone Yield Set Highest Marks For Nasdaq Dividend.. 
Financials ($)
Sales 2018 22 600 M
EBIT 2018 11 508 M
Net income 2018 8 181 M
Finance 2018 6 263 M
Yield 2018 2,77%
P/E ratio 2018 15,68
P/E ratio 2019 14,45
EV / Sales 2018 5,62x
EV / Sales 2019 5,45x
Capitalization 133 B
Duration : Period :
Amgen Technical Analysis Chart | AMGN | US0311621009 | 4-Traders
Technical analysis trends AMGEN
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 25
Average target price 196 $
Spread / Average Target 6,6%
EPS Revisions
Robert A. Bradway Chairman & Chief Executive Officer
Esteban Santos Executive Vice President-Operations
David W. Meline Executive VP, Chief Financial & Accounting Officer
Sean E. Harper Executive Vice President-Research & Development
Paul R. Eisenberg Chief Medical Officer & Senior VP-Global Medical
Sector and Competitors
1st jan.Capitalization (M$)
AMGEN3.23%133 277
JOHNSON & JOHNSON-7.19%352 552
NOVARTIS-3.37%224 301
PFIZER-2.84%212 857
ROCHE HOLDING LTD.-9.37%210 327
MERCK AND COMPANY-0.50%149 572