Breast Cancer: KOL Insight

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Publication Date:
May 2016
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Targeted therapies deliver on promise to transform breast cancer treatment

Targeted therapies continue to transform breast cancer treatment—branching out into new settings, targeting new patient populations, and in some cases upending entire treatment algorithms. Which ones will have the biggest impact on the market as pipeline drugs gain approval?

Find out in FirstWord’s new report, KOL Insight: Breast Cancer.

Packed with insights from 12 key opinion leaders (KOLs) in North America and Europe, the report covers 22 treatments (6 currently marketed and 16 in the pipeline) for 3 major types of breast cancer:

  • HER2+: Discover which clinical trials will decide whether established drugs are approved for use in new settings.
  • HER2-/HR+: Learn how dethroning the dominant drug has ushered in a new era of competition and innovation
  • Triple-negative (TNBC): The first targeted therapies are nearing approval. Find out which patients will benefit first.

“In breast cancer, we are at the helm of trying to identify who is going to benefit.”


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Expert insight into the breast cancer treatment landscape

The report covers 6 marketed drugs and 16 pipeline therapies for 3 major types of breast cancer:

Recently Marketed Drugs

HER2 receptor-positive breast cancer (HER2+)

  • Herceptin (trastuzumab; Genentech/Roche/Chugai): How will the approval of biosimilar trastuzumab affect the way oncologists prescribe Herceptin?
  • Kadcyla (ado-trastuzumab emtansine; Genentech/Roche/Chugai): Have the MARIANNE trial results changed the way Kadcyla is prescribed? How have they influenced KOLs’ views of subsequent trials?
  • Perjeta (pertuzumab; Genentech/Roche/Chugai): How do KOLs view the decision to approve Perjeta for neoadjuvant use based on pCR? Do they expect it to influence future approvals?
  • Tykerb (lapatinib; Novartis): Are alternative treatments limiting use of Tykerb? Which patient population can still benefit from it?

HER2 receptor-negative and hormone receptor-positive breast cancer (HER2-/HR+)

  • Afinitor (everolimus; Novartis): How has uptake of Ibrance changed Afinitor’s place in the treatment paradigm?  What therapeutic sequencing questions have arisen as a result?
  • Ibrance (palbociclib; Pfizer): Is Ibrance becoming the new standard of care? How will the PALLAS and PENELOPE studies affect its prospects in adjuvant and post neoadjuvant settings?

Pipeline Drugs

HER2 receptor-positive breast cancer (HER2+)
  • Gilotrif/Giotrif (afatinib; Boehringer Ingelheim):  What will decide afatinib’s approval for breast cancer treatment? Where will it be positioned relative to Kadcyla and Tykerb?
  • neratinib (PB 272; Puma Biotechnology/Pfizer): How do KOLs view neratinib’s side effects profile, and how will that affect uptake?
  • margetuximab (MGAH 22; MacroGenics): Early data from the SOPHIA trials has generated interest in margetuximab. What key finding is driving KOLs’ optimism?

HER2 receptor-negative and hormone receptor-positive breast cancer (HER2-/HR+)

  • abemaciclib (LY 2835219; Eli Lilly): What important advantage do KOLs say abemaciclib offers, and which patient population stands to benefit the most?
  • ribociclib (LEE 011; Novartis/Astex ): How do KOLs view ribociclib’s potential as part of a combination treatment with PI3K inhibitors?
  • buparlisib (BKM 120; Novartis): Do KOLs think buparlisib is likely to be approved? What factors will determine its prospects?
  • taselisib (GDC 0032; Roche/Genentech): KOLs say taselisib may offer an advantage over pan-PI3K inhibitors like buparlisib. What is it?
  • alpelisib (BYL 719; Novartis): What important concerns about treatment sequencing will affect use of all PI3K inhibitors, including alpelisib?
  • entinostat (SNDX 275; Syndax Pharmaceuticals): Where in the treatment paradigm is entinostat likely to be positioned relative to CDK4/6 inhibitors and PI3K inhibitors?
  • NeuVax (nelipepimut-S; Galena Biopharma): How do KOLs view the potential of immunotherapies in general, and NeuVax specifically, to treat breast cancer?

Triple-negative breast cancer (TNBC)

  • niraparib (MK 4827; Merck & Co.; Tesaro): Are KOLs in favour of combining niraparib with a checkpoint inhibitor?
  • veliparib (ABT 888; AbbVie): What do KOLs expect the Phase III BRIGHTNESS trial to demonstrate?
  • talazoparib (BMN 673; Medivation): Are KOLs optimistic about the results of the Phase II ABRAZO trial? Why do they expect further clinical trials for talzoparib to take a long time?
  • Lynparza (olaparib, AZD 2281; AstraZeneca): What kind of efficacy has Lynparza demonstrated in Phase I and II trials to date?
  • Keytruda (pembrolizumab, MK 3475; Merck & Co.): How do KOLs view potential combinations of Keytruda and a PARP inhibitor? Which PARP inhibitor is the most likely choice?
  • atezolizumab (MPDL 3280A; Roche): How do atezolizumab’s Phase I trial results compare to Keytruda’s. What do KOLs expect the Phase III Impassion130 study to show?

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Top takeaways

  • Roche strengthening its hold on HER2+ treatment: With 3 marketed HER2+ treatments already in its portfolio, Roche is focused on expanding their use. What are their prospects in the adjuvant and neoadjuvant settings?
  • Trials will decide the HER2+ landscape: From KATHERINE and APHINITY to ExteNET, NALA, SOPHIA, etc., learn which clinical trials will decide whether marketed therapies gain approval in new settings, and whether challengers emerge from the pipeline.
  • Questions about biosimilar trastuzumab: Find out whether KOLs are likely to adopt biosimilar trastuzumab, what they expect from manufacturers, and how much influence payers will have on their decisions.
  • Ibrance opened the floodgates for new HER2-/HR+ drugs:  Can any of the several CDK4/6 inhibitors and PI3K inhibitors in the pipeline overcome Ibrance’s first to market advantage?
  • Sequencing is a key concern: With Ibrance pushing Afinitor down the HER2-/HR+ treatment algorithm, and new therapies on the way, what are KOLs concerns about efficacy and optimal therapeutic sequencing?
  • Targeted therapies finally on the horizon for TNBC: With chemotherapy still the only treatment for triple-negative breast cancer, how do KOLs feel about new PARP- and checkpoint inhibitors in the pipeline?
  • TNBC is a “different disease”: KOLs say that treating triple-negative breast cancer isn’t the same as treating other types. What will help them identify patients and treat the disease more effectively?

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Themes Explored

  • Treatment algorithms in flux: KOLs expect significant changes in the near term, especially in HER2-/HR+ treatment, where Afinitor has been relegated to late line use and competition is heating up, and TNBC treatment, where the first targeted therapies are nearing approval.
  • Patient identification is the next big challenge: This is especially true in TNBC treatment, but even in HER2+ and HER2-/HR+ treatment, KOLs say that several drugs may be effective in niche populations, and point to a large unmet need for better patient identification.
  • Pipeline drugs face a slow climb: Few pipeline drugs will see Ibrance’s meteoric rise. KOLs expect several new therapies to debut as late line metastatic treatments, and slowly make their way up the treatment paradigm and into adjuvant and neoadjuvant settings.

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A report based on expert knowledge

Key Opinion Leaders Interviewed for This Report

North American KOLs

  • Prof Catherine Azar, MD; Clinical Associate Professor of Medicine, University of Arizona, Tucson, AZ
  • Prof Ruta D. Rao, MD; Associate Professor of Medicine, Rush University Medical Center, Chicago, IL
  • Prof Adam M. Brufsky, MD, PhD; Professor of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA
  • Prof Charles Vogel, MD; Professor of Clinical Medicine, Division of Haematology/Oncology, Miller School of Medicine, University of Miami, Miami, FL
  • Anonymous, US KOL; Assistant Professor of Clinical Medicine at a leading US institute
  • Anonymous, US KOL; Medical Oncologist specialising in breast cancer at a leading US institute

European KOLs

  • Dr John Conibear, MBBCh, BSc, MSc, MRCP, FRCR; Consultant Oncologist, The Holly Private Hospital, Essex, UK
  • Dr Richard Baird, MBBS, MA, MRCP, PhD; Academic Consultant in Breast Cancer Therapeutics, Cambridge University Hospitals, Cambridge, UK
  • Dr R.J. Salmon; Surgical Oncologist, Institut Curie Hospital, Paris, France
  • Dr Mahasti Saghatchian; Medical Oncologist Specialist in breast cancer, Institut Curie Gustave Roussy, Villejuif, France
  • Anonymous, German KOL; Professor of Oncology and Lead Consultant at a university oncology hospital
  • Anonymous, German KOL; Head of Oncology at a leading German university hospital 

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