Breast Cancer: KOL Insight [2018]

Breast Cancer Market KOL Insight, Industry Analysis 2018

How is biosimilar trastuzumab expected to fare in breast cancer?

Biosimilar trastuzumab is now available in Europe, and key opinion leaders (KOLs) weigh in on how this product is expected to fare after years of Herceptin domination in the HER2-positive space. KOLs discuss how Roche’s Perjeta will be used in the future and whether the APHINITY trial results will change prescribing habits. Experts also give their views on whether the launch of Puma Biotechnology’s Nerlynx in the US has been successful. Meanwhile, in the HER2-negative/HR-positive space, experts provide insights on Pfizer’s first-to-market CDK4/6 inhibitor, Ibrance, and whether Novartis’ Kisqali and Eli Lilly’s Verzenio are succeeding in taking a slice of the market. The US launch of AstraZeneca/Merck & Co.’s Lynparza is discussed in BRCA-mutated triple-negative breast cancer and the potential usage of PD-1/PD-L1 checkpoint inhibitors is also explored.
Twelve US and EU KOLs offer their candid insights on these issues and more.

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Top takeaways

Biosimilar trastuzumab has been launched in Europe. How do KOLs view these products and will patient switching from the branded product become commonplace?
Perjeta is approved as an adjuvant therapy for HER2-positive disease in the US. How do KOLs perceive the APHINITY trial results and will they impact prescribing?
Despite its US launch, Nerlynx has received a negative opinion in Europe. How do US KOLs view Nerlynx’s launch and how will this product be used going forward?
How successful have the Kisqali and Verzenio launches been? And can Pfizer’s Ibrance retain its position as the preferred CDK4/6 inhibitor?
How could the alpha specific PI3 kinase inhibitors, alpelisib and taselisib be positioned in the treatment paradigm? KOLs offer their views on these agents.
Lynparza is now available as a therapy for BRCA-mutated, HER2-negative breast cancer. How is this product currently being prescribed and will usage evolve in the future?
Is talazoparib considered a threat to Lynparza? How do KOLs view talazoparib’s EMBRACA data and does this agent have any particular advantages over Lynparza?
KOLs discuss how checkpoint inhibitors may be used in triple-negative breast cancer (TNBC). What are KOLs’ thoughts on these agents and how do they envisage these products being incorporated in the future?


“Kadcyla has really got an established second-line place, because pertuzumab and Herceptin and Taxotere are approved as first-line on relapse, then theres a very clear spot in which Kadcyla comes in as second-line.” EU Key Opinion Leader

“We give Ibrance to anybody who has first-line metastatic ER-positive breast cancer that doesnt have a visceral crisis needing chemotherapy.” US Key Opinion Leader

Sample of therapies covered

Marketed therapies

Herceptin (trastuzumab; Roche)
Kadcyla (ado-trastuzumab emtansine; Roche)
Perjeta (pertuzumab; Roche)
Tykerb/Tyverb (lapatinib; Novartis)
Nerlynx (neratinib; Puma Biotechnology)
Afinitor (everolimus; Novartis)
Ibrance (palbociclib; Pfizer)
Kisqali (ribociclib; Novartis)
Verzenio (abemaciclib; Eli Lilly)
Lynparza (olaparib; AstraZeneca/Merck & Co.)

Pipeline therapies

margetuximab (MGAH 22; MacroGenics)
alpelisib (BYL 719; Novartis)
taselisib (GDC 0032; Roche)
ipatasertib (GDC 0068; RG 7440; Roche)
entinostat (SNDX 275; Syndax)
talazoparib (BMN 673; Pfizer)
Zejula (niraparib; Tesaro/Merck & Co.)
veliparib (ABT 888; AbbVie)
Keytruda (pembrolizumab; Merck & Co.)
Tecentriq (atezolizumab; Roche)
Bavencio (avelumab; Merck Group/Pfizer)

KOLs interviewed

KOLs from North America

Dr. Adam M. Brufsky, MD, PhD is Professor of Medicine at the University of Pittsburgh School of Medicine, Pittsburgh, P
Dr. Reshma Mahtani, DO is Assistant Professor of Clinical Medicine, Division of Hematology/Oncology, Miller School of Medicine, University of Miami, FL
Dr. Ruta D. Rao, MD is Associate Professor of Medicine, Director, Coleman Comprehensive Breast Center and Director, Hematology & Oncology Fellowship Program at Rush University Medical Center, Chicago, IL
Dr. Sara Tolaney, MD, MPH is an Instructor of Medicine at Harvard Medical School and Attending Physician at the Dana-Farber Cancer Institute, Boston, MA
Dr. Charles L. Vogel, MD is Professor of Clinical Medicine, Division of Hematology/Oncology, Miller School of Medicine, University of Miami, FL
Anonymous, US KOL is an Assistant Professor of Medicine at a leading US institute
KOLs from Europe
Dr. Ahmad Awada, MD is Head of the Medical Oncology Clinic at Jules Bordet Cancer Institute, Brussels, Belgium
Dr. Thomas Bachelot, MD is Head of the Breast Cancer Unit and the Clinical Trial Unit at the Centre Leon Berard, Lyon, France
Dr. Richard Baird, MA MBBS PhD FRCP is Academic Consultant in Experimental Cancer Therapeutics, University of Cambridge and Honorary Consultant in Medical Oncology, Addenbrooke’s Hospital, Cambridge, UK
Dr. Remy Salmon, MD is former Head of the Department of Surgery at the Curie Institute and a specialist in the management of breast cancer at the Saint John of God Foundation Oudinot Clinic, Paris, France
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, London, England
Anonymous, German KOL is the Head of Division at a leading German University Hospital
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1. Executive summary
2. Research objectives
3. Research focus
3.1 Hormone therapy
3.2 Chemotherapy
3.3 Targeted therapies
3.4 Bone-directed therapies
4. HER2 receptor-positive breast cancer
4.1 Overview
4.2 Marketed drugs
4.2.1 Herceptin (trastuzumab; Roche)
4.2.2 Kadcyla (ado-trastuzumab emtansine; Roche)
4.2.3 Perjeta (pertuzumab; Roche)
4.2.4 Tykerb/Tyverb (lapatinib; Novartis)
4.2.5 Nerlynx (neratinib; Puma Biotechnology)
4.3 Pipeline drugs
4.3.1 margetuximab (MGAH22; MacroGenics)
4.4 HER2 receptor-positive breast cancer current and future treatment algorithm
5. HER2 receptor-negative and hormone receptor-positive breast cancer
5.1 Overview
5.2 Marketed drugs
5.2.1 Afinitor (everolimus; Novartis)
5.2.2 Ibrance (palbociclib; Pfizer)
5.2.3 Kisqali (ribociclib; Novartis)
5.2.4 Verzenio (abemaciclib; Eli Lilly)
5.3 Pipeline drugs
5.3.1 Alpha-specific PI3 kinase inhibitors
5.3.2 ipatasertib (GDC 0068; RG 7440; Roche)
5.3.3 entinostat (SNDX 275; Syndax)
5.4 HER2 receptor-negative/HR receptor-positive breast cancer current and future treatment algorithm
6. Triple-negative breast cancer
6.1 Overview
6.2 Marketed drugs
6.2.1 Lynparza (olaparib; AstraZeneca/Merck & Co.)
6.3 Pipeline drugs
6.3.1 talazoparib (BMN 673; Pfizer)
6.3.2 Other late-stage PARP inhibitors
6.3.3 Checkpoint inhibitors
6.4 Triple-negative breast cancer current and future treatment algorithm
7. Appendix
7.1 KOL details
7.1.1 KOLs from North America
7.1.2 KOLs from the EU

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