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The introduction of targeted therapies revolutionised the breast cancer market, widening clinical options and bringing improved survival rates and lower side effects for patients. Now the sector is set for further positive change and expansion as next generation products for HER2-positive disease come to market, and CDK4/6 and P13K inhibitors hold the prospect of new treatments for hormone receptor-positive and HER2-negative breast cancer patients – an area of huge unmet clinical need. Which are the companies and products that will change the commercial and clinical landscape over the next 5 years?

Among the main drivers of change in the breast cancer market...
Roche’s Kadcyla and Perjeta set to transform the treatment of HER2-positive breast cancer
Roche’s Kadcyla (ado-trastuzumab emtansine) and Perjeta (pertuzumab) are both viewed as significant steps forward in the treatment of breast cancer. When added to Herceptin (trastuzumab), Perjeta is the first drug to improve survival in the first-line setting since the availability of Herceptin in 1998. Kadcyla is the first antibody-drug conjugate for the treatment of breast cancer and improves overall survival by almost six months in the second-line setting. To Roche’s commercial benefit, both drugs are set to expand their indications and will likely dominate the market in both the early stages and first lines of treatment for metastatic disease.
No room for biosimilar Herceptin?
Although the availability of biosimilar versions of Herceptin will likely expand in the near future, their prospects are not bright. Kadcyla and Perjeta look set to overtake Herceptin in the early stages and first-line treatment of metastatic HER2-positive breast cancer, thereby limiting the role of biosimilar trastuzumab. Furthermore, Roche’s subcutaneous Herceptin offers more convenient administration than intravenous biosimilar versions. Clinical scepticism and defensive pricing will further limit the prospects for biosimilars in established markets.
New approaches will transform the treatment of hormone receptor-positive and HER2-negative breast cancer
While Novartis’ Afinitor (everolimus) improves progression-free survival in patients with hormone receptor-positive, HER2-negative metastatic breast cancer, it is highly toxic. Interest is now focussed on promising late-stage pipeline candidates. Pfizer’s palbociclib and Novartis’ LEE011 are locked in a race to become the first-to-market CDK4/6 inhibitor. Both drugs are expected to improve survival when combined with an aromatase inhibitor in the first-line treatment of this patient segment and at a lower cost in terms of toxicity. The treatment of hormone receptor-positive, HER2-negative breast cancer will be transformed by the availability of these and PI3K inhibitors such as Pfizer’s buparlisib (BKM120).

Unique insider clinical opinion

This new KOL Insight report Breast Cancer –new targeted therapies transform treatment provides everyone interested in this dynamic cancer sector with a complete understanding of the targeted products which are shaping the current landscape and the research which will change future treatment paradigms.

Every aspect of the report is informed by insights gained from thorough 60-minute interviews with 12 experienced key opinion leaders (KOLs) from across major markets to provide expert views on the current treatment landscape and how it will change in the future. KOLs are selected based on their clinical experience, authored scientific publications, involvement in clinical trials and with the Pharma industry, their participation in treatment guideline development, and their record of presenting at high-profile international conferences. They bring incisive, expert “real world” insights to this fast changing sector.

This report tackles the pressing issues and questions in the breast cancer treatment market:
Which drug is the treatment of choice for each patient segment, line of therapy and unique patient characteristic, and what product attributes contribute to the preference, e.g. first-line treatment of HER2-positive, hormone receptor-positive and HER2-negative, or triple negative disease, and patients with brain metastases?
How is the product perceived by the medical community in terms of efficacy, tolerability, ease of administration, and other product attributes, and how does it compare with other treatment options?
Which recently completed or ongoing clinical trials have the greatest potential to impact prescribing trends and how will the results impact practice in the future, e.g. BOLERO-2, ALTTO, NeoALTTO, MARIANNE, APHINITY, KATHERINE, RESILIENCE, PALOMA-2, etc.?
What will a product need to show in order to become the treatment of choice in a specific patient segment and line of therapy and is it likely the product will meet these requirements?
How will the use of each product change in the future in terms of patient segments, line of therapy and preference, e.g. Roche’s Herceptin, Perjeta, and Kadclya, GlaxoSmithKline’s Tykerb, and Novartis’ Afinitor?
What will the pipeline products need to show in terms of efficacy and tolerability endpoints to effectively compete with current therapies, and what is the likelihood the pipeline products will achieve those endpoints?
Which pipeline products are the most promising and how will they impact current players in the market e.g. Pfizer’s CDK4/6 inhibitor palbociclib (PD 0332991), Novartis’ PI3K inhibitor buparlisib (BKM120) and AstraZeneca’s PARP inhibitor olaparib (AZD 2281)?



This report will allow you to:


<Understand and evaluate the important drivers in targeted breast cancer treatments
<Fully evaluate how the competitive landscape may change
<Understand clinical opinions of current and futures products and how they will change treatment algorithms
<Survey and appraise the late-stage product pipeline










KOL Insight Benefits

Understand and assess future breast cancer market developments
Analyse current and future treatment algorithms
Understand the strengths and weaknesses of currently available targeted therapies for breast cancer
Assess how prescribing trends will change with launch of new products
Identify promising late-stage pipeline products
Track KOL opinion continuously over the next 12 months




Selected Quotes from the Report




“There's more and more evidence showing that using combination HER2 blockade is the right thing to do. So, at the moment, I think it [Herceptin] will remain the backbone of the combination approach. If the patient relapsed on T-DM1 then you might go on to Herceptin plus pertuzamab or Herceptin plus pertuzamab plus another drug.” EU Key Opinion Leader

“There are issues that have not yet been well-defined for biosimilars. My decision to use a biosimilar will depend on the basis of approval. I need more transparency to be confident. Has it been used in the metastatic setting? Can it be used in the adjuvant setting? Will there be testing for cardiotoxicity? The answers to these questions should be clear. I don’t think there will be much use of biosimilar Herceptin because the criteria used by the European Medicines Agency (EMA) are very [different], so this drug [biosimilar Herceptin] is basically less tested. We don't trust the development.” EU Key Opinion Leader

“T-DM1 [Kadcyla] is a tremendous step forward. It’s as big an advance as Herceptin was when that was first developed. It's clearly very effective and it's also very well tolerated, so it's a win-win really for the patients. I've been amazed at both the responses and the low side-effect profile of treatment. So, I can see it probably sweeping the board in time.” EU Key Opinion Leader

“Right now I am most excited and encouraged with the CDK 4/6 inhibitor palbociclib. It is an oral therapy; it is well tolerated; and it shows improvements in efficacy that are double to triple of what we have seen with hormonal therapy alone. So far, I am very excited about it and I think it is going to move quickly.” US Key Opinion Leader

“PARP inhibitors could have a huge impact for a small subpopulation of patients that have a BRCA1 or BRCA2 mutation. Within those populations there is a good chance that they will indeed show better time to progression and survival.” EU Key Opinion Leader



KOL Panel


KOLs from North America:
Dr. Carlos L. Arteaga MD is Associate Director for Clinical Research, Director, Breast Cancer Research Program, and Director, Center for Cancer Targeted Therapies at the Vanderbilt-Ingram Cancer Center (VICC), Vanderbilt University, Nashville, TN.
Dr. Kimberly L. Blackwell, MD is Professor of Medicine and Assistant Professor of Radiation Oncology at Duke University Medical Center, Durham, NC.
Dr. Adam M. Brufsky, MD, PhD, is Professor of Medicine at the University of Pittsburgh School of Medicine, Pittsburgh, PA.
Dr. Ana Maria Gonzalez-Angulo, MD, MSc, FACP, is Associate Professor, Department of Breast Medical Oncology and Chief, Section of Clinical Research and Drug Development, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
Dr. Reshma Mahtani, DO is Assistant Professor of Clinical Medicine, Division of Hematology/Oncology, Miller School of Medicine, University of Miami, Miami, FL.
Dr. Charles Vogel, MD is Professor of Clinical Medicine, Division of Hematology/Oncology, Miller School of Medicine, University of Miami, Miami, FL.

KOLs from Europe:
Dr. Thomas Bachelot, MD, is Head of the Breast Cancer Unit and the Clinical Trial Unit at the Centre Leon Berard, Lyon, France.
Dr. Rob Coleman, MBBS, MD, FRCP, is Professor Department of Oncology, Weston Park Hospital, Sheffield, England, UK.
Dr. Alessandra Gennari, MD, PhD, is Medical Director, Medical Oncology Unit, Galliera Hospital, Genoa, Italy.
Dr. Adrian L. Harris, MD, DPhil is Professor of Medical Oncology at the University of Oxford and Director of the Cancer Research UK Medical Oncology Unit.
Professor Gunter von Minckwitz is Managing Director of the German Breast Group (GBG) Research Institute.
Dr. Rafael Trujillo is Medical Oncologist, Xanit International Hospital, Malaga, Spain.














Updated Continually

This report is continually updated in response to market developments stay in touch with the latest developments and thinking and maximise the value of this report

The world of pharma is ever changing and executives must always be up-to-date with the latest developments that could affect their own products, position and research. That is why FirstWord’s guarantee to keep Therapy Trends updated offers real commercial advantage. Consider the benefits:
Content will be fully updated in response to market developments such as new product approvals or pivotal research results for 12 months from the date of purchase
Such updates are incorporated throughout the KOL reports ensuring the change is reflected in every aspect of the report
There is no limit and all relevant events will result in an update
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All updates are included in the price.

Whatever happens in the market you’ll always be able to assess the impact with FirstWord Therapy Trends

Unrivalled Sources Ensure Complete Coverage

Our unique disease selection matrix pinpoints those disease sectors of the highest commercial potential, and draws information from multiple novel and expert sources, including:
Exclusive views from leading global experts
Comprehensive consensus research
Live meeting dispatches and critical industry data
Data from over 125 medical conferences attended by FirstWord researchers each year
Online opinions from 535,000 vetted physicians
Over 2,000 peer-reviewed medical journals
Over 450 pharmaceutical news sources




Table Of Contents

Breast Cancer: New targeted therapies transform treatment - KOL Insight
1.Executive Summary

2.Research Objectives

3.Research Focus

4.Patient Segment Analysis
5.HER2 Receptor Positive Breast
5.1.Overview
5.2.Pivotal trial data
5.3.Key trials to watch
5.4.Marketed drugs
5.4.1.Herceptin (trastuzumab; Genentech/Roche/C

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