Market Research Report
Multiple Myeloma Disease Coverage Forecast and Market Analysis
|Published by||Datamonitor Healthcare||Product code||962431|
|Published||Content info||144 Pages
Delivery time: 1-2 business days
|Multiple Myeloma Disease Coverage Forecast and Market Analysis|
|Published: September 17, 2020||Content info: 144 Pages||
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.
Datamonitor Healthcare 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.
to earlier lines of therapy