GSK’s Blenrep Scores World-First Approval in UK for Multiple Myeloma

GlaxoSmithKline plc (GSK plc) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Blenrep for use in the United Kingdom. The drug treats adults with multiple myeloma in combination with bortezomib and dexamethasone (BVd) for patients who have received at least one previous therapy, and in combination with pomalidomide and dexamethasone (BPd) for those previously treated with lenalidomide. This marks the first global regulatory approval of Blenrep for use in these treatment combinations.

Phase III Trials Show Significant PFS and OS Benefits Supporting MHRA Approval of Blenrep

The MHRA’s authorisation of Blenrep combinations is supported by efficacy data from the pivotal DREAMM-7 and DREAMM-8 phase III trials in patients with relapsed or refractory multiple myeloma. Both studies demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) for Blenrep-based regimens compared to standard treatments. Additionally, DREAMM-7 showed a significant overall survival (OS) benefit. The safety and tolerability profiles of the Blenrep combinations generally matched those of the individual agents used in the trials.

In DREAMM-7, the Blenrep combination achieved a median PFS of 36.6 months, nearly tripling that of the daratumumab-based comparator arm, which reported 13.4 months. The study also met a key secondary endpoint, showing a statistically significant 42% reduction in the risk of death, with a hazard ratio of 0.58. At a median follow-up of 39.4 months, the Blenrep arm achieved a three-year OS rate of 74%, compared to 60% in the daratumumab arm.

In the DREAMM-8 trial, the Blenrep combination also showed a notable PFS benefit. At a median follow-up of 21.8 months, the Blenrep arm had not yet reached the median PFS, while the bortezomib-based comparator arm showed a median PFS of 12.7 months. These results further support the clinical value of Blenrep combinations in improving outcomes for patients with relapsed or refractory multiple myeloma.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said, “Today’s approval of Blenrep combinations in the UK is a transformative milestone for patients with multiple myeloma, a cancer marked by remission and relapse. As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse.”

Only 55% of UK Multiple Myeloma Patients Survive 5 Years

Most patients with multiple myeloma eventually experience disease relapse, and in the United Kingdom, only 55% of patients survive five years after diagnosis. Blenrep offers a novel therapeutic option as the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) currently approved for use in multiple myeloma, delivering a distinct mechanism of action for patients at or following relapse.

Healthcare providers can administer Blenrep-based combinations across a wide range of patient populations and oncology care settings. The treatment does not require complex pre-administration protocols or hospitalisation, offering greater flexibility and convenience for both patients and healthcare providers.

Joseph Mikhael, MD, Chief Medical Officer, International Myeloma Foundation and Professor, Translational Genomics Research Institute, City of Hope Cancer Center, said, “As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival. We are pleased to see this advancement in the treatment landscape extended across both academic and community settings where many patients are treated.”

In addition to Blenrep, several other therapies are available for the treatment of relapsed or refractory multiple myeloma. These include proteasome inhibitors such as bortezomib and carfilzomib, immunomodulatory drugs like lenalidomide and pomalidomide, and monoclonal antibodies targeting CD38, such as daratumumab and isatuximab. More recently, advanced immunotherapies like CAR-T cell therapies targeting BCMA, including idecabtagene vicleucel and ciltacabtagene autoleucel, have shown promising results in heavily pre-treated patients. These therapies expand treatment options, but many require complex administration procedures or face limitations in access and availability.

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Denisse Sandoval