Multiple myeloma (MM) is currently the third most prevalent form of blood cancer in the world. Approximately 150,000 people are diagnosed with the disease worldwide every year.
The disease is characterised by a proliferation of plasma cells that produce an excess of clonal immunoglobulin.
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This build-up results in bone lesions, immunosuppression, and kidney damage, and can eventually lead to cardiovascular complications such as thromboembolic events.
Over the last four decades, developments in new treatments, particularly immunomodulatory drugs, proteasome inhibitors, and autologous stem-cell transplantation therapy, have doubled the five-year survival for patients with MM to more than 50%.
Despite these achievements, many patients will experience relapsed/refractory MM (RRMM).
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While there are many treatment options available to patients who suffer from sequential RRMM such as monoclonal antibody therapy and cell therapies, there is a need for more therapeutic options due to diminishing prognoses with each line of therapy used in RRMM.
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By GlobalDataResearch in RRMM has driven more investment in the field of B-cell maturation antigen (BCMA)-targeted therapies.
BCMA is highly expressed on the myeloma cell surface, and its concentration in serum has a negative association with prognosis.
GSK’s Blenrep (belantamab mafodotin) is a BMCA-targeting antibody-drug conjugate that was previously trialled in the DREAMM-3 study, which enrolled 325 patients.
DREAMM-3 assessed Blenrep for third-line therapy against the standard of care, pomalidomide-dexamethasone regimen.
The trial showed that Blenrep had a numerical improvement to progression-free survival (PFS) against pomalidomide-dexamethasone (11.2 months versus 7.0 months), but failed in demonstrating significance (hazard ratio 1.03; p=0.56).
The consequences of this trial have been far-reaching, as the US Food and Drug Administration requested Blenrep’s withdrawal from the US market and the EU Committee for Medicinal Products for Human Use voted against renewing its marketing authorisation.
Although the withdrawal and shelving of Blenrep seemed all but inevitable, positive results from DREAMM-7 have allowed GSK to reconsider its position.
The DREAMM-7 Phase III study randomised 494 patients to receive Blenrep or Johnson & Johnson’s Darzalex (daratumumab) in addition to a second-line combination therapy of Takeda’s Velcade (bortezomib) and dexamethasone.
An announcement by GSK on 27 November detailed some of the interim results of DREAMM-7, specifically that Blenrep significantly improved PFS (P<0.0005) and showed clinically meaningful improvement in overall survival.
Currently, drug entry into the early lines of treatment in the RRMM market is challenging due to Darzalex’s dominance and familiarity with prescribers.
A real-world evidence analysis of Darzalex’s efficiency in combination with Bristol Myers Squibb’s Revlimid (lenalidomide) and dexamethasone regimen showed a PFS benefit of 14.1 months compared to Revlimid and dexamethasone alone (P<0.001) in RRMM patients who had received one to three lines of therapy, but not in heavily pretreated patients (three or more prior lines of therapy).
GlobalData’s patient-based forecast predicts global Darzalex sales to reach $4.15bn while Blenrep will reach sales of $681m in the US, UK, EU, Japan, and China by 2027.
The current difficulty facing Blenrep is prescriber hesitance due to the announcement of its market withdrawal last year.
Furthermore, data in the DREAMM-2 study revealed that grade 3-4 keratopathy was present in 27% of patients (n=95) receiving a 2.5mg/kg dose and was also present in 21% of patients (n=99) receiving a 3.4mg/kg dose.
Other common grade 3-4 events include thrombocytopenia and neutropenia, which can exacerbate symptoms and increase morbidity in patients at risk of infections.
While Blenrep will not encapsulate a significant portion of the market share, its utility as another option for patients potentially relapsing from Darzalex or Revlimid gives it some potential to become an effective therapeutic option for a difficult-to-treat malignancy.
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