Blenrep combos approved in UK as multiple myeloma treatment
Treatment combinations cleared for relapsed, refractory myeloma
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Blenrep (belantamab mafodotin) in combination with other medications for hard-to-treat multiple myeloma.
The MHRA approved Blenrep in combination with Velcade (bortezomib) and dexamethasone for people with myeloma who have received at least one prior line of therapy, and Blenrep plus Pomalyst (pomalidomide) and dexamethasone (PomDex) in patients who’ve had one prior line of treatment including Revlimid (lenalidomide).
According to Blenrep’s developer GSK, this marks the first worldwide approval of Blenrep-based combos to treat myeloma that has relapsed (come back after initially responding to treatment) or is refractory (resistant to treatment). Applications seeking similar approvals of Blenrep combination therapies are under review in more than a dozen countries, including the U.S. and the European Union.
“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,” Hesham Abdullah, MD, senior vice president and global head of oncology research and development at GSK, said in a company press release.
The MHRA’s approval was based on data from two Phase 3 clinical trials, DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623).
Combinations among myeloma treatment options
Data from DREAMM-7 showed that Blenrep plus Velcade and dexamethasone was better than a combination treatment using Darzalex (daratumumab) at reducing the risk of disease progression and improving survival odds for people with myeloma who’d had at least one prior round of therapy. Likewise, DREAMM-8 showed that Blenrep plus Pomalyst and dexamethasone outperformed standard care at reducing the risk of disease progression in patients who’d had at least one prior line of therapy including Revlimid.
Common safety issues seen in patients given Blenrep included low blood cell counts, diarrhea, and COVID-19. Eye-related issues, a known side effect of the therapy, were also seen but were usually manageable, according to GSK. The company noted that fewer than one in 10 patients in the trials stopped taking Blenrep due to side effects.
“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,” said Joseph Mikhael, MD, chief medical officer of the International Myeloma Foundation. “We are pleased to see this advancement in the treatment landscape extended across both academic and community settings where many patients are treated.”
Blenrep is an antibody-drug conjugate. The therapy contains an antibody that targets BCMA, a protein expressed by myeloma cells. The BCMA-targeting antibody is attached to a toxic molecule called auristatin F. Blenrep uses the antibody to deliver this toxic molecule to myeloma cells, killing them.
“As the only BCMA-targeted [antibody-drug conjugate] 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,” Abdullah said.
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