ASCO24: GSK’s Blenrep nearly halves risk of disease progression, death in myeloma study

02 Jun 2024
firstwordpharma.com
Clinical ResultPhase 3ASCO
New data unveiled on Sunday showed that GSK’s BCMA-targeted antibody-drug conjugate Blenrep (belantamab mafodotin) cut the risk of disease progression or death by nearly half in patients with relapsed or refractory multiple myeloma (RRMM). The findings from the Phase III DREAMM-8 trial were presented at the American Society of Clinical Oncology (ASCO) annual meeting and follow the company’s surprise announcement in March that the study had hit its primary endpoint.
The trial compared Blenrep to bortezomib, both in combination with Bristol Myers Squibb's Pomalyst (pomalidomide) and dexamethasone in 302 patients with RRMM.
Data unveiled at ASCO showed that for the study’s main goal, after follow-up of around 22 months, median progression-free survival (PFS) was not reached for participants who received Blenrep, while it was 12.7 months for those on the bortezomib regimen. At the end of the first year, PFS was 71% for those given GSK’s therapy compared to 51% for those in the bortezomib group.
Meanwhile, the overall response rate was 77% for those receiving Blenrep, versus 72% for those on the bortezomib regimen, with a complete response or better achieved in 40% and 16% of patients in the two groups, respectively. In addition, among those with disease that responded to treatment, the median duration of response was not yet reached in those given Blenrep and it was 17.5 months in those in the bortezomib treatment arm.
Benefit of community setting
“This combination may have potential to redefine treatment of multiple myeloma at or after first relapse, a setting where patients may benefit from novel therapies,” remarked lead study author Suzanne Trudel. “It is suitable for a broad range of patients and can be given in a community oncology setting without the need for specialised cancer centre support.”
GSK noted that while a positive overall survival (OS) trend was seen in the study – with a hazard ratio of 0.77 – the difference was not statistically significant and further follow-up analyses are planned. In the meantime, Hesham Abdullah, global head of oncology R&D at the drugmaker, said “we continue to share data and discuss our path forward with regulators.”
The findings from DREAMM-8 come shortly after GSK detailed results from the Phase III DREAMM-7 trial, in which Blenrep extended PFS by 59% compared to Johnson & Johnson's Darzalex (daratumumab) as a second-line treatment for patients with RRMM (for related analysis, see Spotlight On: Will GSK’s Blenrep redemption be commercial or cathartic?).
Ocular events reversible, manageable
In DREAMM-7, Grade 3 or higher ocular adverse events (AEs) occurred in 34% of patients receiving Blenrep, while 9% stopped treatment due to these side effects. Meanwhile, in DREAMM-8, Grade 3 or higher ocular AEs - such as blurred vision and dry eye - were seen in 43% of participants given GSK’s therapy, with 9% discontinuing treatment as a result. However, the company noted that the eye-related side effects “were generally reversible [and] manageable with dose modifications.”
Despite the safety concerns, a recent FirstWord survey of US haematologists and oncologists found that nearly 60% said they are “likely” or “very likely” to prescribe Blenrep in transplant-eligible or transplant-ineligible MM patients who have received at least four prior therapies if it returns to the market.
Blenrep was yanked from the US market in 2022 after it failed to show superiority over the combination of Pomalyst and low-dose dexamethasone in the confirmatory Phase III DREAMM-3 study of patients with RRMM. Following the DREAMM-7 and -8 successes, GSK indicated recently that it plans to submit marketing applications as a second-line and later treatment for patients with RRMM in the US, EU, Japan and China in the second half of the year.
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