GSK Revives Blenrep Blockbuster Hopes With Phase III Data

GSK is reconsidering its approach to the multiple myeloma treatment Blenrep (belantamab mafodotin) following a brief hiatus from the market in late 2022. During a virtual investor event focused on oncology, company executives highlighted the drug's significant potential, pointing to it as a potential major revenue driver.

This optimism is anchored in encouraging results from two Phase III clinical trials, DREAMM-7 and DREAMM-8. These studies demonstrated strong efficacy signals for Blenrep-based treatment regimens in patients with multiple myeloma who had previously received at least one line of therapy.

In the DREAMM-7 trial, Blenrep was compared to Johnson & Johnson’s Darzalex (daratumumab). The results showed a "significant increase" in progression-free survival (PFS) for those receiving Blenrep. Specifically, there was a nearly 60% reduction in the risk of disease progression or death compared to Darzalex. This PFS benefit was statistically significant, with a p-value of less than 0.00001.

The median PFS for patients treated with Blenrep was 36.6 months, whereas it was only 13.4 months for those receiving Darzalex. GSK described this 23-month difference as both statistically significant and clinically meaningful.

Furthermore, Blenrep showed a promising trend toward better overall survival (OS) compared to Darzalex. The DREAMM-7 study will continue monitoring for OS outcomes. Additionally, patients on the Blenrep regimen had a superior depth of response, with more than double the percentage achieving at least a complete response compared to those on Darzalex.

The DREAMM-8 study also provided promising results, comparing a Blenrep-based regimen to a treatment schedule involving Takeda’s Velcade (bortezomib). Patients on Blenrep experienced a "statistically significant and clinically meaningful" nearly 50% reduction in the risk of disease progression or death compared to the Velcade group. At the time of analysis, the median PFS for Velcade was 12.7 months, but it had not yet been reached for Blenrep patients.

Similar to DREAMM-7, the depth of response was greater in the Blenrep group in DREAMM-8, with more than twice the percentage of patients achieving a complete response or better compared to those on Velcade.

These favorable outcomes have led GSK’s Chief Commercial Officer, Luke Miels, to project that Blenrep could achieve peak sales exceeding $3 billion, primarily driven by its use as a second-line treatment for multiple myeloma. Miels suggested that Blenrep has the potential to replace Darzalex as the standard care in this setting.

Blenrep, an antibody-drug conjugate targeting the BCMA protein, was initially approved by the FDA in August 2020 through its accelerated approval pathway. At that time, it was sanctioned as a monotherapy for patients with relapsed or refractory multiple myeloma who had previously been treated with a proteasome inhibitor, an anti-CD38 antibody, and an immunomodulatory agent.

However, in November 2022, GSK withdrew Blenrep from the U.S. market after it failed to meet its primary efficacy endpoint in the confirmatory Phase III DREAMM-3 trial. 

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