Will novel targeted therapies establish a place in CLL treatment pathways?
Chemo-immunotherapy regimens incorporating Rituxan/MabThera have traditionally been at the forefront of CLL treatment. How is this all set to change within the next few years? With Imbruvica and Venclexta/Venclyxto on the market, how do key opinion leaders (KOLs) see uptake of these treatments shaping up? Will targeted therapy combinations be able to match the efficacy of conventional regimens and become the new standards of care? Novel drugs acalabrutinib and umbralisib (TGR-1202) are also in the pipeline but what are the most important factors to ensure utilisation of these novel agents? Learn how KOLs see the market evolving, and how they expect developers to differentiate their pipeline therapies in KOL Insight: Chronic Lymphocytic Leukaemia (CLL). Twelve US and European KOLs provide their candid insights on seven marketed products and five Phase III pipeline programmes.
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- Chemo-immunotherapies have dominated front-line treatment in CLL, but how long is this likely to continue? Will Roche's anti-CD20 franchise, including Rituxan/MabThera and Gazyva/Gazyvaro, preserve their market share in a competitive landscape shifting towards oral targeted drugs?
- How will Imbruvica's role evolve in treatment of CLL? Following expanded approval of Janssen/AbbVie's Imbruvica to first-line treatment, and publication of long-term efficacy data, how is the drug matching up to conventional regimens so far?
- Is Venclexta/Venclyxto likely to become a key player? Find out how KOLs are prescribing this drug following its 2016 approval in CLL, how it compares to Imbruvica and Gilead's Zydelig, and if can compete with these agents in the long-term?
- How do KOLs feel about the extrapolated approval of rituximab biosimilars from non-Hodgkin lymphoma (NHL) to CLL? Will rituximab biosimilars be used in the treatment of CLL, and will cost be the key driver of uptake? Or will availability of subcutaneous Rituxan/MabThera limit adoption of rituximab biosimilars altogether?
- Can acalabrutinib forge a niche in the treatment algorithm? Find out if KOLs think Acerta/AstraZeneca's acalabrutinib is likely to gain approval in CLL, and whether the drug can compete with Imbruvica.
- How do KOLs view PI3 kinase inhibitors as future treatments in CLL? Two PI3 kinase inhibitors are in the pipeline (Verastem's duvelisib and TG Therapeutics' umbralisib (TGR-1202), but which one are KOLs most excited about?
- What other early-stage pipeline programmes are KOLS particularly excited about?Anti-CD19 CAR-T therapies have been game-changing in other haematologic malignancies but will the same hold true for CLL?
- Are targeted drug combinations the future of CLL? Which combinations do KOLs think will be superior and will they be able to side-line chemotherapy regimens?
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"We will possibly get to cure CLL. There will be more combinations. The question is which is the best, the most affordable, and has least toxicity?" EU Key Opinion Leader
"In the next few years, it is very likely that chemotherapy will be completely replaced with targeted therapies." US Key Opinion Leader
Sample of therapies covered
- Rituxan/MabThera (rituximab; Roche)
- Gazyva/Gazyvaro (obinutuzumab; Roche)
- Arzerra (ofatumumab; Novartis)
- Imbruvica (ibrutinib; Janssen Biotech/AbbVie)
- Zydelig (idelalisib; Gilead)
- Venclexta/Venclyxto (venetoclax; AbbVie/Roche)
- Truxima* (CT-P10; Celltrion/Teva/Mundipharma)
- Rixathon/Riximyo* (GP2013; Sandoz/Novartis)
- acalabrutinib (Acerta Pharmaceuticals/AstraZeneca)
- duvelisib (Verastem)
- umbralisib (TGR-1202; TG Therapeutics)
- ublituximab (TG Therapeutics)
- Revlimid (lenalidomide; Celgene)
- PF-05280586* (Pfizer)
- ABP 798* (Amgen)
KOLs from North America
- Dr. Paul M. Barr, MD; Associate Professor of Medicine and Director of the Clinical Trials Office for the Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.
- Dr. Joshua Brody, MD; Assistant Professor of Hematology and Medical Oncology at the Mount Sinai Hospital, New York.
- Dr. Bruce D. Cheson, MD, PhD; Professor of Medicine, Head of Hematology, and Director of Hematology Research at Lombardi at Georgetown University, Washington D.C.
- Dr. Steven Coutre, MD; Professor of Medicine (Hematology) at the Stanford University Medical Center, Stanford University, California.
- Dr. Ryan Jacobs, MD; Hematology and Oncology specialist at Carolinas Medical Center, Charlotte, North Carolina.
- Dr. Nitin Jain, MD; Assistant Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
KOLs from Europe
- Professor Christopher Fegan, MB, MD, FRCP, FRCPath; Consultant Haematologist and Director of the School of Medicine at Cardiff University, Wales, UK.
- Dr. Francesco Forconi MD, DM, PhD, FRCPath; Associate Professor in Haematological Oncology, and Honorary Consultant in Haematology at the University of Southampton, UK.
- Professor Paulo Ghia, MD, PhD; Associate Professor at the Universita Vita-Salute San Raffaele and Head of the Unit of B-cell Neoplasia at the San Raffaele Scientific Institute at the San Raffaele Scientific Institute in Milan, Italy.
- Dr. Marco Montillo, MD; Haematology Specialist at Department of Onco-Haematology, Division of Hematology, Niguarda Ca' Granda Hospital, Milan, Italy.
- Professor Olivier Tournihac, MD, PhD; Professor of Haematology at Clermont-Ferrand University Hospital, Clermont-Ferrand, France.
- Anonymous, German KOL, MD, PhD; Associate Professor of Haematology at a leading German University.
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Table of Contents
1. Executive summary
2. Research objectives
3. Research focus
4. Current treatments
- 4.1 Overview
- 4.2 Unmet needs
- 4.3 Anti-CD20 therapies
- 4.3.1 Overview
- 4.3.2 Rituxan/MabThera (rituximab; Roche)
- 4.3.3 Rituximab biosimilars
- 4.3.4 Gazyva/Gazyvaro (obinutuzumab; Roche)
- 4.3.5 Arzerra (ofatumumab; Novartis)
- 4.4 Other targeted therapies
- 4.4.1 Imbruvica (ibrutinib; Janssen Biotech/AbbVie)
- 4.4.2 Zydelig (idelalisib; Gilead)
- 4.4.3 Venclexta/Venclyxto (venetoclax; AbbVie/Roche)
5. Late-stage pipeline drugs
- 5.1 acalabrutinib (ACP-196; Acerta Pharmaceuticals/AstraZeneca)
- 5.2 duvelisib (IPI-145; Verastem)
- 5.3 umbralisib (TGR-1202; TG Therapeutics)
- 5.4 ublituximab (TG-1101; TG Therapeutics)
- 5.5 Revlimid (lenalidomide; Celgene)
- 5.6 Innovative early-stage approaches
6. Current and future treatment algorithm
- 7.1 KOL details 179
- 7.1.1 KOLs from North America 179
- 7.1.2 KOLs from the EU