Dublin, Oct. 09, 2020 (GLOBE NEWSWIRE) -- The "Multiple Myeloma Disease Coverage Forecast and Market Analysis" report has been added to ResearchAndMarkets.com's offering.
Multiple myeloma is characterized by the infiltration of malignant, antibody-producing plasma cells in the bone marrow. Almost all cases occur in individuals aged over 40 years, and age at diagnosis has an impact on patient outcome, especially in terms of the treatment options available. Most patients will receive at least three lines of treatment, and eligible patients will receive stem cell transplantation.
Latest Key Takeaways
The publisher estimates that in 2018, there were 134,100 incident cases of multiple myeloma (MM) in adults aged 40 years and older worldwide, and expects that number to increase to 153,700 incident cases by 2027.
The launch of BCMA-targeted therapies will play a pivotal part in future market dynamics over the next decade. Key new product launches will include the antibody-drug conjugate (ADC) Blenrep and the CAR-T therapies ide-cel and JNJ-4528. Given the unmet need for effective therapies for heavily pretreated patients, uptake is expected to be rapid.
Revlimid, a thalidomide analog, and Velcade, a proteasome inhibitor (PI), are key therapies across patient segments, both as monotherapies and as backbones for combination regimens. These drugs have broad approvals across all markets, and the expected expiry of their patents will exert substantial downward pressure on the MM market.
Darzalex, the first monoclonal antibody (MAb) approved for MM, has experienced steady uptake and has become a new standard of care based on impressive trial results in the relapsed/refractory MM (RRMM) setting. The drug, a CD38-targeted MAb, will experience continual commercial success due to several label expansions in the newly diagnosed MM and RRMM settings, as well as the recent approval of a more convenient subcutaneous formulation.
Sarclisa, another CD38-directed MAb, is expected to face intense in-class competition from Darzalex, especially in the relapsed/refractory setting where Sarclisa gained its first approval as a treatment for RRMM patients who have received at least two prior therapies. Although Sarclisa is currently relegated to the highly competitive later lines of therapy, where it will also compete with Farydak, Empliciti, and Velcade, label expansions to earlier treatment settings will expand its commercial potential.
Bristol Myers Squibb, which also markets Revlimid, has positioned Pomalyst as a subsequent therapy option. Pomalyst, another thalidomide analog, adds a treatment option to Bristol Myers Squibb's MM portfolio, but faces increasing competition in the late-stage treatment setting from a number of approved and pipeline therapies.
Second-generation PI Kyprolis is approved for the treatment of RRMM as a monotherapy and in combination with either dexamethasone, Darzalex and dexamethasone, or Revlimid and dexamethasone. Kyprolis remains the favored PI in the RRMM setting as it demonstrated improved safety and efficacy over Velcade, another PI, in the Phase III ENDEAVOR trial. However, unlike Velcade, Kyprolis does not offer a subcutaneous formulation.
In combination with Revlimid and dexamethasone, Ninlaro, the first oral PI approved by the FDA, is part of an all-oral regimen approved for the treatment of patients with relapsed MM with one prior line of therapy. Ninlaro has seen consistent sales in the MM market due to its convenient administration, a competitive price, and the combination's relatively favorable safety profile.
Empliciti, the only SLAMF7-targeted MAb approved for MM, has seen moderate uptake since the combination of Empliciti, Revlimid, and dexamethasone (ERd) was approved for the treatment of MM patients who have received one to three prior lines of therapy. A label expansion in combination with Pomalyst and dexamethasone for the treatment of MM patients who have received at least two prior therapies provided expanded options for the use of Empliciti in the treatment of RRMM, but did not significantly improve the drug's commercial potential in this crowded treatment space.
The XPO1 inhibitor Xpovio represents the first novel mechanism approved for MM since the approval of the anti-SLAMF7 antibody Empliciti. Xpovio in combination with dexamethasone is approved in the US for patients with RRMM who have received at least four prior therapies and whose disease is refractory to at least two PIs, at least two immunomodulatory agents, and an anti-CD38 MAb. Given the small patient population, Xpovio has experienced only limited uptake, although label expansions to earlier treatment settings will expand the drug's commercial potential.
Ygalo is in the BLA phase as a treatment for patients with triple-refractory MM, but this novel dipeptide prodrug of melphalan has only a modest commercial outlook given it will face significant competition from both approved and late-phase competitors in an increasingly crowded market. Although Ygalo demonstrated a 26% overall response rate in the registrational Phase II HORIZON study, the BCMA-directed therapies have shown better efficacy results. Ygalo is also being developed for earlier lines of therapy, where it may find greater commercial success.
Venclexta is positioned to be approved for a limited subset of RRMM patients. The FDA placed a clinical hold on all Venclexta trials in MM after the Phase III BELLINI study showed a higher mortality rate in patients treated with the combination of Venclexta, Velcade, and dexamethasone than in patients treated with Velcade/dexamethasone. However, the FDA lifted the partial clinical hold exclusively for the Phase III CANOVA study of Venclexta in combination with dexamethasone for the treatment of patients with RRMM positive for the translocation (11;14) abnormality, and topline results from the trial are expected in 2021.
Key recent events include Blenrep's approval in the US and EU for heavily pretreated MM, approval of a subcutaneous formulation of Darzalex, and two Phase III failures: Ninlaro in the induction setting (TOURMALINE-MM2), and Kyprolis in an ECOG study comparing Kyprolis or Velcade combined with Revlimid and dexamethasone (KRd vs VRd) in front-line MM. Other key events include Ygalo's success in the pivotal Phase II HORIZON study as a treatment for triple-refractory MM, and two Phase III successes for second-line or later MM: Sarclisa's success in IKEMA in combination with Kyprolis and dexamethasone, and Xpovio's success in BOSTON in combination with Velcade and dexamethasone.
Key upcoming catalysts for the next year include the expected US approvals of ide-cel and Ygalo, and label expansions in the US for Xpovio.
The overall likelihood of approval of a Phase I MM asset is 6.9%, and the average probability a drug advances from Phase III is 58.3%. MM drugs, on average, take 8.6 years from Phase I to approval, compared to 9.4 years in the overall oncology space.
Key Topics Covered:
Latest key takeaways
Smoldering multiple myeloma
Active multiple myeloma
Key Regulatory Events
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
UK Multiple Myeloma Patients Allowed Early Access To Sanofi's Isatuximab
GSK Files Its BCMA Drug In Multiple Myeloma
Celgene Gets Another Myeloma CAR-T Accepted Onto EMA's PRIME
EU Approvals: J&J's Darzalex Steps Ahead With New Indication
Karyopharm's Xpovio In Multiple Myeloma Priced At $22,000 Per Four-Week Cycle
Probability of Success
Licensing and Asset Acquisition Deals
Kiadis And Sanofi Sign Natural Killer Cell Therapy Pact
Bluebird Revises Business Priorities And Secures Upfront Cash From Bristol
Harpoon Finds A Blood Cancer Partner In AbbVie
Amgen Joins China Oncology Market Race With $2.7bn BeiGene Stake
Clinical Trial Landscape
Sponsors by status
Sponsors by phase
Drug Assessment Model
Genericization of key brands Revlimid and Velcade 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
The growth of pipeline and newly approved drugs in the relapsed/refractory setting will be dependent on label expansions
to earlier lines of therapy
Recent Events and Analyst Opinion
Darzalex for Multiple Myeloma (July 31, 2020)
Blenrep for Multiple Myeloma (July 14, 2020)
Blenrep for Multiple Myeloma (July 10, 2020)
UCARTS1 for Multiple Myeloma (July 6, 2020)
Sarclisa for Multiple Myeloma (June 2, 2020)
Kyprolis for Multiple Myeloma (May 31, 2020)
Sarclisa for Multiple Myeloma (May 31, 2020)
CC-92480 for Multiple Myeloma (May 31, 2020)
Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020)
JNJ-64007957 for Multiple Myeloma (May 29, 2020)
Xpovio for Multiple Myeloma (May 28, 2020)
Blenrep for Multiple Myeloma (May 27, 2020)
Ide-cel for Multiple Myeloma (May 13, 2020)
Sarclisa for Multiple Myeloma (May 12, 2020)
Ygalo 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)
Blenrep for Multiple Myeloma (December 16, 2019)
Darzalex for Multiple Myeloma (December 10, 2019)
C-CAR088 for Multiple Myeloma (December 7, 2019)
CC-93269 for Multiple Myeloma (December 7, 2019)
JNJ-4528 for Multiple Myeloma (December 7, 2019)
ide-cel for Multiple Myeloma (December 6, 2019)
Ninlaro for Multiple Myeloma (November 7, 2019)
Daratumumab-rHuPH20 (Subcutaneous) for Multiple Myeloma (September 15, 2019)
Multiple Drugs for Multiple Myeloma (September 13, 2019)
Blenrep for Multiple Myeloma (August 23, 2019)
CERC-007 for Multiple Myeloma (August 7, 2019)
Darzalex for Multiple Myeloma (July 8, 2019)
Xpovio for Multiple Myeloma (July 3, 2019)
GEN3014 for Multiple Myeloma (June 11, 2019)
Sarclisa for Multiple Myeloma (June 2, 2019)
AMG 420 for Multiple Myeloma (June 2, 2019)
Darzalex for Multiple Myeloma (June 2, 2019)
Iberdomide for Multiple Myeloma (June 2, 2019)
Darzalex for Multiple Myeloma (June 2, 2019)
Iberdomide for Multiple Myeloma (May 15, 2019)
Key Upcoming Events
Key Opinion Leader Insights
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