This edition presents key opinion leader (KOL) views on recent developments in the multiple myeloma (MM) market. Topics covered include; Amgen’s announcement of positive results from a planned overall survival (OS) interim analysis of the Phase III head-to-head ENDEAVOR trial, which showed that patients with relapsed or refractory MM (rrMM) treated with Kyprolis and dexamethasone lived 7.6 months longer than those treated with Velcade and dexamethasone; Cellectar Biosciences initiating the fourth cohort in its Phase I clinical trial of its lead candidate CLR 131 in patients with rrMM, where patients will start at a 31.25 mCi/m2 dose, a 25 percent increase on the dose used in the third cohort; and Genzyme’s announcement of the initiation of the Phase III ICARIA-MM trial of isatuximab, an investigational anti-CD38 monoclonal antibody being studied for the treatment of patients with rrMM. The trial will compare isatuximab in combination with pomalidomide (Pomalyst/Imnovid; Celgene) and dexamethasone against pomalidomide and dexamethasone.
*Latest* Update 1: March 2017
*Latest* Update 2: Dec 2016
*Latest* Update 1: Sept 2016
Original Publication: June 2016
*Purchase of this report includes all updates*
This update tackles these key questions
- What do KOLs think of ibudilast’s safety and efficacy?
- If approved, where would ibudilast be positioned in the treatment paradigm?
- How is RHB 104, an oral antibiotic combination, viewed by KOLs?
- How have KOLs reacted to the removal of the pregnancy contraindication from the European label for Copaxone injection 20mg/ml?
- What is the general consensus among KOLs regarding generic versions of Copaxone?
Gain new KOL insights on the latest events that have the potential to impact the treatment landscape of multiple myeloma (MM). Topics covered include expert opinions on: Takeda receiving a recommendation for approval for Ninlaro (ixazomib; Takeda), in combination with Revlimid (lenalidomide; Celgene) and dexamethasone, from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP); Janssen Biotech applying to US and EU regulators for expanded use of Darzalex (daratumumab), in combination with Revlimid (lenalidomide) and dexamethasone, or Velcade (bortezomib) and dexamethasone, for the treatment of adult relapsed MM patients who have received at least one prior line of therapy; and Karyopharm Therapeutics announcing positive top-line results from the Phase IIb STORM clinical study for its lead candidate, selinexor (KPT-330), a first in class oral selective inhibitor of nuclear export (SINE), for the treatment of patients heavily pre-treated for MM.
Gain new KOL insights on the latest events happening in Multiple Myeloma (MM): Positive data from two Phase III studies (CASTOR, POLLUX) of Darzalex (daratumumab) in relapsed or refractory multiple myeloma; AbbVie’s Phase III study of orally administered venetoclax in combination with Velcade and dexamethasone in patients with relapsed or refractory MM and Karyopharm Therapeutics’ Phase IIb STORM study for selinexor (KPT-330), an oral selective inhibitor of nuclear export (SINE).
Original Publication: Are monoclonal antibodies (mAbs) set to steal the spotlight in MM treatment, despite their expense?
Demand persists in haematological oncology for novel, effective modalities that improve outcomes for multiple myeloma (MM) patients.
Two recently marketed monoclonal antibody (mAb) therapies are creating great excitement. But how will this new class fare against established therapies, plus five drugs/therapies currently in the pipeline, including a new humanised mAb? And will their high cost prove prohibitive?
Find out in FirstWord’s new report, Multiple Myeloma: KOL Insight Request sample pages now
Covering nine drugs on the market (three recently marketed) plus five currently in the pipeline, the report provides compelling insights into the MM landscape from 12 key opinion leaders (KOLs) in North America and Europe.
You’ll learn whether mAbs are set to transform the clinical landscape, how costs could dictate continued use of otherwise obsolete treatments and – with the arrival of a new generic – might weigh on the adoption of the newer more effective therapies. Meanwhile, will new treatments in the pipeline quickly challenge mAbs as future stars in the MM therapy arena?
Plus: Order the report and you’ll receive three quarterly FirstWord Therapy Trends Update Bulletins free!Request sample pages now
“Myeloma is an interesting disease because we have these novel therapies that are extremely well-tolerated, and quite efficacious – so the bar is high.”
Expert insight into the multiple myeloma treatment landscape
Currently Marketed Drugs
Immunomodulatory drugs (IMiDs)
- Revlimid (lenalidomide; Celgene): Despite the effectiveness of Pomalyst, why do KOLs expect the use of Revlimid-based combinations to increase in the next few years?
- Pomalyst (pomalidomide; Celgene): As the next-generation thalidomide analogue, what role do KOLs expect Pomalyst to play in relation to Revlimid?
- Thalomid (thalidomide; Celgene): Could economic constraints in some geographies delay thalidomide’s obsolescence?
Proteasome inhibitors (PIs)
- Velcade (bortezomib; Takeda/Janssen Biotech): What will be the knock-on effect on newer PIs with the arrival of generic bortezomib?
- Kyprolis (carfilzomib; Amgen): Are there significant combination options for Kyprolis despite some of its drawbacks?
- Ninlaro (ixazomid; Takeda): What does the future hold for Ninlaro in a world with Kyprolis and generic bortezomib?
Recently Marketed Drugs
Histone deacetylase (HDAC) inhibitors
- Farydak (panobinostat; Novartis): How concerned are KOLs about toxicity, and will this impact future usage? How do KOLs compare its efficacy with drugs such as bortezomib and lenalidomide?
Monoclonal antibodies (mAbs)
- Dazarlex (daratumumab; Genmab/Janssen Biotech): Will high costs dampen enthusiasm for this exciting new treatment?
- Empliciti (elotuzumab; AbbVie/Bristol-Myers Squibb): How do KOLs rate Empliciti’s efficacy compared to Dazarlex?
Pipeline DrugsSmall molecule therapies
- Zelboraf (vemurafenib; Roche/Plexxikon): How concerned are KOLs about known side effects and the danger of secondary malignancies? In which combinations might it more safely be used?
- Arry-520 (filanesib; Array): Will cumbersome supportive care requirements relegate filanesib in future treatment algorithms?
- Masitinib (AB Science): What combination options are KOLs suggesting for masitinib if it proves ineffective as a single agent?
- Aplidin (plitidepsin; PharmaMar/Chugai): Why are KOLs divided on the outlook for this first-in-class drug?
Programmed death receptor-1 inhibitors
- Keytruda (pembrolizumab; Merck & Co.): Which existing therapies will be most threatened if Keytruda meets current high expectations?
- Will IMiDs and PIs remain the backbone of treatment? How will newer variants and the imminent arrival of generic PIs alter therapeutic strategies going forward?
- Is the hype surrounding novel mAb therapies justified? Do KOLs feel the excitement is fully justified and what concerns remain about their safety and potential?
- Could Keytruda be a future disruptor? The shifting balance of power between treatments may receive a further jolt if promising trial data are confirmed. But who do KOLs think will be the winners and losers?
- Why do KOLs remain sceptical about small molecules? To date, the orally active small molecule therapies in the pipeline haven’t fully won over the KOLs, despite being attractive strategies. Will they find a place in the treatment algorithm?
- Are cost and reimbursement concerns set to increase? Cost will dictate how combination regimens evolve. In what ways will older, cheaper therapies influence different parts of the algorithm?
- Is talk of a ‘cure’ for MM realistic, or wishful thinking? Reducing toxicity and improving progression-free survival will feature prominently in the treatment paradigm. Patients are now living longer than before, but is a cure for MM on the horizon?
A report based on expert knowledge
Key Opinion Leaders Interviewed for This Report
North American KOLs
- Roger N. Pearse, MD, PhD. Associate Professor of Medicine, Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medical College, Cornell University, Ithaca, NY.
- Kenneth C. Anderson, MD. Kraft Family Professor of Medicine, Harvard Medical School and Director, Lebow Institute for Myeloma Therapeutics, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston, MA.
- Carol Ann Huff, MD. Director, Myeloma Program, Assistant Professor of Oncology and Medicine, The Johns Hopkins University, Baltimore, MD.
- Noopur Raje, MD. Director, Center for Multiple Myeloma, Massachusetts General Hospital and Associate Professor of Medicine, Harvard Medical School, Boston, MA.
- Joseph R. Mikhael, MD. Associate Professor of Medicine, Mayo Clinic Arizona.
- Paul G. Richardson, MD. R.J. Corman Professor, Medicine, Harvard Medical School and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston, MA.
- Philippe Rodon, MD. Consultant Physician and Head of Onco-Haematology, Centre Hospitalier de Perigueux, CH Blois, France.
- Karthik Ramasamy, MBBS, MRCP, FRCPath, PhD. Consultant Haematologist, Cancer and Haematology Centre, Churchill Hospital, Headington, Oxford, UK.
- Maria Teresa Petrucci, MD. Consultant Physician and Director of Haematology Department of Cellular Biotechnology – Hospital Umberto, Azienda Policlinico Umberto I, University La Sapienza, Roma, Italy.
- Didier Bouscary, MD. Professor of Haematology at Paris Diderot University and Head of Haematology at Hopital Cochin, Paris, France.
- German KOL (Anonymous). Professor of Haematology at a leading university hospital in Germany.
- German KOL (Anonymous). Professor of Internal Medicine at a leading university in Germany.
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