Multiple myeloma (MM) is a hematological malignancy characterized by the infiltration of malignant, antibody-producing plasma cells in the bone marrow. The disease represents approximately 1% of all cancers, and 10% of hematological cancers. The hallmarks of MM are high levels of monoclonal (M-) protein, high levels of clonal plasma cells in the bone marrow, and organ damage. Plasma cells normally produce antibodies in response to infection or allergens, but in MM a plasma cell clone starts to proliferate and produce excessive amounts of one type of abnormal antibody, referred to as M-protein or paraprotein. In addition to high levels of M-protein, most patients with active MM have some form of organ damage caused by the proliferation of plasma cells and the high levels of protein in the blood and urine. Typical signs of organ damage include hypercalcemia, renal insufficiency, anemia, and bone lesions.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
11 DISEASE BACKGROUND
11 Definition
11 Risk factors
11 Presentation
12 Symptoms
13 Diagnosis
14 Patient segmentation
15 Co-morbidities
16 Subtypes
18 TREATMENT
18 Smoldering multiple myeloma
18 Active multiple myeloma
18 Active multiple myeloma: first line, SCT eligible
19 Active multiple myeloma: first line, SCT ineligible
20 Active multiple myeloma: first-line disease
21 Active multiple myeloma: relapsed/refractory
22 Active multiple myeloma: progressive or relapsed disease
24 Approvals for key multiple myeloma regimens
27 EPIDEMIOLOGY
27 Incidence methodology
31 MARKETED DRUGS
37 PIPELINE DRUGS
57 KEY REGULATORY EVENTS
57 High-Stakes Meeting With EMA On The Cards For Oncopeptides’ Pepaxto
57 BMS’s Revlimid Loss Of Exclusivity Is Not As Bad As Expected, But Not For Long
57 Fresenius And Aurobindo Among Fresh Velcade Challengers In US
58 Zydus Settles On Revlimid In US
58 Accord Sees Two Hybrids Endorsed By EU’s CHMP
58 Janssen’s Multiple Myeloma Gene Therapy On Track For EU-Wide Approval
59 New Data Helps Darzalex & Zejula Switch To Routine Funding In England
59 New EU Filings
59 Teva Pounces On US Revlimid Opportunity With Four Strength-Offering
60 Dr Reddy’s And BMS Shake Hands On Pomalyst Settlement
60 Janssen/Legend Plan Phased US Launch For BCMA-Targeting CAR-T Carvykti
60 Revlimid Rivals Launch Across Europe
61 Magrolimab Falls Off The Fast Track As Gilead Reveals New Clinical Holds
61 Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA
62 Accord’s UK Lenalidomide Launch Kicks Off A Year Of Revlimid Competition
62 Janssen And Sanofi Keep Mum On EU Fast-Track Request Outcomes
62 Farydak Bids Adieu
63 Approval Delayed, But Janssen/Legend’s Cilta-Cel May Hit Market Just In Time
63 Cilta-Cel Reverts To Standard Review In EU
63 239 Days: Oncopeptides’ Myeloma Drug Pepaxto Comes Off Market Just Months After Accelerated Approval
64 Dr Reddy’s Eyes Generic Revlimid Exclusivity With ANDA Approval
64 Further Companies Confirm Canadian Revlimid Rivals
64 Revlimid Rivals Debut In Canada
65 Will Production Bottlenecks For BMS’s Abecma Pose Problems After EU Approval?
65 Pepaxto’s Accelerated Approval In Myeloma May Sink On OCEAN Trial’s Adverse Survival Data
66 EMA OKs BMS/bluebird bio’s CAR-T Abecma For Multiple Myeloma
66 Sun Settles On Revlimid As Natco Scoops First ANDA Approval
66 Breckenridge Eyes First Kyprolis Generic With FDA Approval
66 Ciltacabtagene Autoleucel And Melflufen Among Myriad New Filings In EU
67 Pfizer’s Elranatamab Among New Entrants On EMA’s PRIME
68 PROBABILITY OF SUCCESS
69 LICENSING AND ASSET ACQUISITION DEALS
69 Otsuka Licenses Global Rights For R8H283 From Osaka University
69 SteroTherapeutics Licenses Rights For MMP-13 Inhibitors
69 Sanofi Challenges J&J’s Darzalex With Blackstone Pact For SC Sarclisa
69 Huadong Pays $20m Up Front For ADCs From Heidelberg
70 Sana Licenses BCMA CAR Construct From IASO And Innovent Bio
70 Bristol Partners With Century On Cancer Cell Therapies
70 Sanofi Hopes Owkin Can Aid Oncology Discovery
71 I-Mab Readies For Commercial Activity Via Pact With Sinopharm
71 Bluebird Spinoff 2seventy Bio Gets Its Own Wings
71 Sanofi Gets IP From MSKCC, Eureka Applicable In Multiple Myeloma Therapy
72 AbbVie Acquires TeneoOne And Lead Multiple Myeloma Candidate
72 Alliance For CAR-T Therapy
73 CLINICAL TRIAL LANDSCAPE
74 Sponsors by status
75 Sponsors by phase
76 Recent events
82 DRUG ASSESSMENT MODEL
92 MARKET DYNAMICS
93 FUTURE TRENDS
93 Genericization of key brands Velcade, Revlimid, Pomalyst, and Kyprolis will substantially slow market growth
93 New BCMA-targeted therapies will contribute to growth in the multiple myeloma market over the forecast period
94 Label expansions of marketed drugs will help balance out downturn in the market
95 Drugs with a novel mechanism of action, such as Xpovio and Blenrep, will move into earlier lines of therapy, while
talquetamab will seek its first approval
96 CONSENSUS FORECASTS
100 RECENT EVENTS AND ANALYST OPINION
100 Pepaxto for Multiple Myeloma (January 21, 2022)
101 ALLO-715 for Multiple Myeloma (January 10, 2022)
102 Teclistamab for Multiple Myeloma (December 13, 2021)
103 Ciltacabtagene Autoleucel for Multiple Myeloma (December 12, 2021)
104 RG6160 for Multiple Myeloma (December 11, 2021)
105 Sarclisa for Multiple Myeloma (December 11, 2021)
107 Talquetamab for Multiple Myeloma (December 11, 2021)
108 Pepaxto for Multiple Myeloma (October 22, 2021)
109 Multiple Drugs for Multiple Myeloma (October 7, 2021)
110 Pepaxto for Multiple Myeloma (September 11, 2021)
112 Pepaxto for Multiple Myeloma (July 8, 2021)
114 Darzalex for Multiple Myeloma (June 12, 2021)
115 Ciltacabtagene Autoleucel for Multiple Myeloma (June 1, 2021)
117 Pepaxto for Multiple Myeloma (May 25, 2021)
120 KEY UPCOMING EVENTS
121 KEY OPINION LEADER INSIGHTS
123 UNMET NEEDS
124 BIBLIOGRAPHY
126 APPENDIX
LIST OF FIGURES
29 Figure 1: Trends in incident cases of multiple myeloma, 2018–27
37 Figure 2: Overview of pipeline drugs for multiple myeloma in the US
37 Figure 3: Pipeline drugs for multiple myeloma, by company
38 Figure 4: Pipeline drugs for multiple myeloma, by drug type
38 Figure 5: Pipeline drugs for multiple myeloma, by classification
68 Figure 6: Probability of success in the multiple myeloma pipeline
73 Figure 7: Clinical trials in multiple myeloma
73 Figure 8: Top 10 drugs for clinical trials in multiple myeloma
74 Figure 9: Top 10 companies for clinical trials in multiple myeloma
74 Figure 10: Trial locations in multiple myeloma
75 Figure 11: Multiple myeloma trials status
76 Figure 12: Multiple myeloma trials sponsors, by phase
82 Figure 13: Datamonitor Healthcare’s drug assessment summary for multiple myeloma
92 Figure 14: Market dynamics in multiple myeloma
93 Figure 15: Future trends in multiple myeloma
112 Figure 16: Pepaxto for Multiple Myeloma (September 11, 2021): Phase III – OCEAN
114 Figure 17: Pepaxto for Multiple Myeloma (July 8, 2021): Phase III – OCEAN
115 Figure 18: Darzalex for Multiple Myeloma (June 12, 2021): Phase III – MAIA (MMY3008)
117 Figure 19: Ciltacabtagene Autoleucel for Multiple Myeloma (June 1, 2021): Phase Ib/II – CARTITUDE-1 (Dose Finding)
119 Figure 20: Pepaxto for Multiple Myeloma (May 25, 2021): Phase III – OCEAN
120 Figure 21: Key upcoming events in multiple myeloma
LIST OF TABLES
12 Table 1: Diagnostic criteria for MGUS and smoldering multiple myeloma
13 Table 2: Symptoms of advanced multiple myeloma
15 Table 3: ISS criteria for multiple myeloma
15 Table 4: R-ISS criteria for multiple myeloma
16 Table 5: Common co-morbidities associated with multiple myeloma
17 Table 6: Common cytogenetic abnormalities associated with multiple myeloma
21 Table 7: Recommended front-line pharmacological therapies for multiple myeloma
23 Table 8: NCCN recommended treatment regimens for previously treated multiple myeloma
24 Table 9: ESMO recommended treatment regimens for previously treated multiple myeloma
25 Table 10: Approvals for key multiple myeloma regimens, by country
28 Table 11: Incident cases of multiple myeloma, 2018–27
30 Table 12: Incident cases of multiple myeloma, by gender, 2018
32 Table 13: Marketed drugs for multiple myeloma
39 Table 14: Pipeline drugs for multiple myeloma in the US
83 Table 15: Results from the Phase II KarMMa and CARTITUDE-1 studies in multiple myeloma
85 Table 16: Darzalex’s label expansions for multiple myeloma
86 Table 17: First-line approvals being pursued for SC Darzalex in multiple myeloma
97 Table 18: Historical global sales, by drug ($m), 2017–21
99 Table 19: Forecasted global sales, by drug ($m), 2022–26
100 Table 20: Pepaxto for Multiple Myeloma (January 21, 2022)
101 Table 21: ALLO-715 for Multiple Myeloma (January 10, 2022)
102 Table 22: Teclistamab for Multiple Myeloma (December 13, 2021)
103 Table 23: Ciltacabtagene Autoleucel for Multiple Myeloma (December 12, 2021)
104 Table 24: RG6160 for Multiple Myeloma (December 11, 2021)
106 Table 25: Sarclisa for Multiple Myeloma (December 11, 2021)
107 Table 26: Talquetamab for Multiple Myeloma (December 11, 2021)
108 Table 27: Pepaxto for Multiple Myeloma (October 22, 2021)
109 Table 28: Multiple Drugs for Multiple Myeloma (October 7, 2021)
110 Table 29: Pepaxto for Multiple Myeloma (September 11, 2021)
113 Table 30: Pepaxto for Multiple Myeloma (July 8, 2021)
114 Table 31: Darzalex for Multiple Myeloma (June 12, 2021)
116 Table 32: Ciltacabtagene Autoleucel for Multiple Myeloma (June 1, 2021)
118 Table 33: Pepaxto for Multiple Myeloma (May 25, 2021)
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