Disease Analysis: Multiple Myeloma

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Report
134 Pages
May 2021
Region: Global
Citeline
ID: 5148347

Definition

Asthma is a chronic respiratory condition characterized by recurrent wheezing, coughing, and breathlessness, which occur in acute events known as exacerbations. Often triggered by factors such as exercise, allergen or irritant exposure, change in weather, or viral respiratory infections, these flare-ups can vary significantly in frequency and severity. Attacks consist of swelling of the lining of the bronchial tubes, which narrows airways and results in a reduction of airflow into and out of the lungs. Historically considered to be a single disease, asthma is now viewed more as an overlapping assemblage of individual phenotypes with various underlying pathophysiological processes leading to symptoms.

Latest Key Takeaways

The publisher estimates that in 2018, there were approximately 343.6 million prevalent cases of asthma in individuals aged up to 44 years worldwide, and forecasts that number to increase to 363.7 million prevalent cases by 2027.
The GINA treatment strategy released in 2019 included an important change disrupting a fundamental practice in mild asthma management. Treatment with a short-acting beta 2 agonist (SABA) alone is no longer recommended for adults and adolescents with asthma. While short-acting bronchodilators may provide symptom relief for patients, they remain at risk for severe exacerbations. In late 2020, a similar, but still distinct update was made to the NAEPP guidelines.
The majority of approved drugs in the asthma space are inhaled small molecules, while several newer approvals show a shift towards the development of injectable biologics.
Since its launch as the first fixed-dose combination (FDC) of an inhaled corticosteroid (ICS) and a long-acting beta 2 agonist (LABA), GlaxoSmithKline’s Advair has become a well-established gold-standard therapy in asthma. However, generic competition in Europe, and more recently in the US, marks the end of this successful history.
Novartis has ended development of its asthma drug fevipiprant following data which showed that the once-daily pill was not effective.
The convenience of pipeline ICS/LABA/long-acting muscarinic antagonist (LAMA) triple FDC therapies will only marginally increase the overall use of the LAMA drug class as physicians remain skeptical about the role of LAMAs in asthma.
Key upcoming catalysts in asthma include topline results from Phase III studies for SABA/ICS combination PT027.

OVERVIEW

Latest key takeaways

DISEASE BACKGROUND

Definition
Risk factors
Presentation
Symptoms
Diagnosis
Patient segmentation
Co-morbidities
Subtypes

TREATMENT

Smoldering multiple myeloma
Active multiple myeloma
Active multiple myeloma: first line, SCT eligible
Active multiple myeloma: first line, SCT ineligible
Active multiple myeloma: first-line disease
Active multiple myeloma: relapsed/refractory
Active multiple myeloma: progressive or relapsed disease
Approvals for key multiple myeloma regimens

EPIDEMIOLOGY

Incidence methodology

MARKETED DRUGSPIPELINE DRUGS

KEY REGULATORY EVENTS

Pfizer’s Elranatamab Among New Entrants On EMA’s PRIME
BMS/Bluebird Ready Abecma, First BCMA-Targeting CAR-T, For Initial Patients
EU Early Access For Melphalan Flufenamide
Early-Stage R&D In The Spotlight As BMS Patent Expirations Approach
EU Fast-Track Fail For Another BMS CAR-T Cell Therapy
EMA PRIME Wins For Bispecific Antibodies & Another Gene Therapy
Janssen Wins EU Fast-Track Status For CAR-T Therapy Cilta-Cel
Bumpy EU Review Ends Well For Selinexor Filing
Early FDA Approval For Karyopharm’s Xpovio
Krka, Accord And Xeris Pick Up European Nods
PharmaMar Victory Has EU Regulators Pondering Next Move
NICE OKs Sarclisa & Mayzent For Funding In England, But Rejects Vindaqel
Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications
Approval Of BMS/Bluebird’s Ide-Cel May Come Just In Time
Kyprolis+Darzalex Offers Relapsed Myeloma Patients An IMiD-Free Regimen
GSK To Address Multiple Myeloma With First-In-Class Blenrep In EU
GSK’s Blenrep Wins BCMA Race, Carries Ocular Toxicity Warning
EMA Says Yes To GSK’s Belantamab
GSK’s Myeloma Drug Gets AdComm Backing, But Limitations Remain Clear
Concerns About Eye Toxicity Could Limit GSK’s Myeloma Drug Potential
Sanofi Is ‘Working On’ Resolving England’s Sarclisa Funding Concerns
New EU Approvals
Manufacturing Issues Ground bluebird/Bristol ‘Ide-Cel’ CAR-T
Approval For New Darzalex Dosing
Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

Wugen Aligns With Alpha Biopharma For Asia Markets
SELLAS Licenses Greater China Rights For Immunotherapies To 3D
Kiadis And Sanofi Sign Natural Killer Cell Therapy Pact
Bluebird Revises Business Priorities And Secures Upfront Cash From Bristol

CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase
Recent events

DRUG ASSESSMENT MODELMARKET DYNAMICS

FUTURE TRENDS

Genericization of key brands Velcade, Revlimid, and Pomalyst will substantially slow market growth
New BCMA-targeted therapies will contribute to growth in the multiple myeloma market over the forecast period
Label expansions of marketed drugs will help balance out downturn in the market
Drugs with a novel mechanism of action, such as Xpovio, Pepaxto, and Blenrep, will move into earlier lines of therapy

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

Darzalex for Multiple Myeloma (December 7, 2020)
bb21217 for Multiple Myeloma (December 5, 2020)
CT053 for Multiple Myeloma (December 5, 2020)
JNJ-4528 for Multiple Myeloma (December 5, 2020)
MEDI2228 for Multiple Myeloma (December 5, 2020)
Multiple Drugs for Multiple Myeloma (December 5, 2020)
RG6160 for Multiple Myeloma (December 5, 2020)
Teclistamab for Multiple Myeloma (December 5, 2020)
Talquetamab for Multiple Myeloma (December 5, 2020)
UCARTCS1 for Multiple Myeloma (November 17, 2020)
Darzalex Faspro for Multiple Myeloma (July 31, 2020)
Blenrep for Multiple Myeloma (July 14, 2020)
Blenrep for Multiple Myeloma (July 10, 2020)
UCARTCS1 for Multiple Myeloma (July 6, 2020)
Sarclisa for Multiple Myeloma (June 2, 2020)
CC-92480 for Multiple Myeloma (May 31, 2020)
Kyprolis for Multiple Myeloma (May 31, 2020)
Sarclisa for Multiple Myeloma (May 31, 2020)
Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020)
Teclistamab for Multiple Myeloma (May 29, 2020)
Xpovio for Multiple Myeloma (May 28, 2020)
Blenrep for Multiple Myeloma (May 27, 2020)
Abecma for Multiple Myeloma (May 13, 2020)
Sarclisa for Multiple Myeloma (May 12, 2020)
Pepaxto for Multiple Myeloma (March 26, 2020)
Ninlaro for Multiple Myeloma (March 10, 2020)
Empliciti for Multiple Myeloma (March 9, 2020)
Xpovio for Multiple Myeloma (March 2, 2020)

KEY UPCOMING EVENTSKEY OPINION LEADER INSIGHTSUNMET NEEDSBIBLIOGRAPHYAPPENDIX

LIST OF FIGURES

Figure 1: Trends in incident cases of multiple myeloma, 2018–27
Figure 2: Overview of pipeline drugs for multiple myeloma in the US
Figure 3: Pipeline drugs for multiple myeloma, by company
Figure 4: Pipeline drugs for multiple myeloma, by drug type
Figure 5: Pipeline drugs for multiple myeloma, by classification
Figure 6: Probability of success in the multiple myeloma pipeline
Figure 7: Clinical trials in multiple myeloma
Figure 8: Top 10 drugs for clinical trials in multiple myeloma
Figure 9: Top 10 companies for clinical trials in multiple myeloma
Figure 10: Trial locations in multiple myeloma
Figure 11: Multiple myeloma trials status
Figure 12: Multiple myeloma trials sponsors, by phase
Figure 13: The publisher’s drug assessment summary for multiple myeloma
Figure 14: Market dynamics in multiple myeloma
Figure 15: Future trends in multiple myeloma
Figure 16: JNJ-4528 for Multiple Myeloma (December 5, 2020): Phase Ib/II - CARTITUDE-1 (Dose Finding)
Figure 17: Sarclisa for Multiple Myeloma (June 2, 2020): Phase III - IKEMA (w/Carfilzomib+Dex)
Figure 18: Kyprolis for Multiple Myeloma (May 31, 2020): Phase III - ECOG Study - w/Bortezomib/Lenalidomide/Dexamethasone (VRd)
Figure 19: Sarclisa for Multiple Myeloma (May 31, 2020): Phase II - GMMG-CONCEPT
Figure 20: Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020): Phase I/II - EVOLVE
Figure 21: Teclistamab for Multiple Myeloma (May 29, 2020): Phase I - CR108206
Figure 22: Xpovio for Multiple Myeloma (May 28, 2020): Phase III - BOSTON
Figure 23: Blenrep for Multiple Myeloma (May 27, 2020): Phase II - DREAMM-6 (w/ Vd or Rd)
Figure 24: Sarclisa for Multiple Myeloma (May 12, 2020): Phase III - IKEMA (w/Carfilzomib+Dex)
Figure 25: Pepaxto for Multiple Myeloma (March 26, 2020): Phase II - HORIZON
Figure 26: Ninlaro for Multiple Myeloma (March 10, 2020): Phase III - TOURMALINE-MM2 (w/Len/Dex (First Line))
Figure 27: Empliciti for Multiple Myeloma (March 9, 2020): Phase III - ELOQUENT-1
Figure 28: Xpovio for Multiple Myeloma (March 2, 2020): Phase III - BOSTON
Figure 29: Key upcoming events in multiple myeloma

LIST OF TABLES

Table 1: Diagnostic criteria for MGUS and smoldering multiple myeloma
Table 2: Symptoms of advanced multiple myeloma
Table 3: ISS criteria for multiple myeloma
Table 4: R-ISS criteria for multiple myeloma
Table 5: Common co-morbidities associated with multiple myeloma
Table 6: Common cytogenetic abnormalities associated with multiple myeloma
Table 7: Recommended front-line pharmacological therapies for multiple myeloma
Table 8: NCCN recommended treatment regimens for previously treated multiple myeloma
Table 9: ESMO recommended treatment regimens for previously treated multiple myeloma
Table 10: Approvals for key multiple myeloma regimens, by country
Table 11: Incident cases of multiple myeloma, 2018–27
Table 12: Incident cases of multiple myeloma, by gender, 2018
Table 13: Marketed drugs for multiple myeloma
Table 14: Pipeline drugs for multiple myeloma in the US
Table 15: Historical global sales, by drug ($m), 2016–20
Table 16: Forecasted global sales, by drug ($m), 2021–25
Table 17: Darzalex for Multiple Myeloma (December 7, 2020)
Table 18: bb21217 for Multiple Myeloma (December 5, 2020)
Table 19: CT053 for Multiple Myeloma (December 5, 2020)
Table 20: JNJ-4528 for Multiple Myeloma (December 5, 2020)
Table 21: MEDI2228 for Multiple Myeloma (December 5, 2020)
Table 22: Multiple Drugs for Multiple Myeloma (December 5, 2020)
Table 23: RG6160 for Multiple Myeloma (December 5, 2020)
Table 24: Teclistamab for Multiple Myeloma (December 5, 2020)
Table 25: Talquetamab for Multiple Myeloma (December 5, 2020)
Table 26: UCARTCS1 for Multiple Myeloma (November 17, 2020)
Table 27: Darzalex Faspro for Multiple Myeloma (July 31, 2020)
Table 28: Blenrep for Multiple Myeloma (July 14, 2020)
Table 29: Blenrep for Multiple Myeloma (July 10, 2020)
Table 30: UCARTCS1 for Multiple Myeloma (July 6, 2020)
Table 31: Sarclisa for Multiple Myeloma (June 2, 2020)
Table 32: CC-92480 for Multiple Myeloma (May 31, 2020)
Table 33: Kyprolis for Multiple Myeloma (May 31, 2020)
Table 34: Sarclisa for Multiple Myeloma (May 31, 2020)
Table 35: Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020)
Table 36: Teclistamab for Multiple Myeloma (May 29, 2020)
Table 37: Xpovio for Multiple Myeloma (May 28, 2020)
Table 38: Blenrep for Multiple Myeloma (May 27, 2020)
Table 39: Abecma for Multiple Myeloma (May 13, 2020)
Table 40: Sarclisa for Multiple Myeloma (May 12, 2020)
Table 41: Pepaxto for Multiple Myeloma (March 26, 2020)
Table 42: Ninlaro for Multiple Myeloma (March 10, 2020)
Table 43: Empliciti for Multiple Myeloma (March 9, 2020)
Table 44: Xpovio for Multiple Myeloma (March 2, 2020)

Table of Contents

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