EU committee recommends Blenrep combos for approval in RRMM
The recommendation is based on results from two Phase 3 trials
A committee of the European Medicines Agency has recommended approving GSK’s Blenrep (belantamab mafodotin) in combination with other therapeutic agents to treat relapsed or refractory multiple myeloma (RRMM).
The recommendation from the Committee for Medicinal Products for Human Use (CHMP) covers Blenrep in combination with Velcade (bortezomib) plus dexamethasone (BorDex), or Pomalyst (pomalidomide) plus dexamethasone (PomDex) in patients who’ve received at least one previous line of treatment.
”Today’s positive CHMP opinion is an important milestone toward bringing the benefits of Blenrep combinations to patients with multiple myeloma in Europe,” Hesham Abdullah, GSK’s senior vice president and global head of oncology research and development said in company press release.
The European Commission (EC), the regulatory body of the European Union, typically follows CHMP recommendations, but they aren’t binding. The recommendation for Blenrep is based on results from two Phase 3 trials. The company expects a final EC decision by the third quarter of this year. If accepted, it would let people who’ve tried at least one other myeloma therapy use BorDex plus Blenrep. The PomDex combination would carry the caveat that at least one prior therapy must have been lenalidomide (sold as Revlimid and generics).
What is Blenrep?
Myeloma is a rare cancer that begins in plasma cells, a type of white blood cell. Plasma cells, which typically produce antibodies to fend off diseases, grow out of control when they become cancerous. This growth occurs in bone marrow, the spongy interior of some bones where blood cells develop.
When masses occur at multiple bone marrow sites, the disease is referred to as multiple myeloma. RRMM includes cases that recur after a period of remission or don’t respond to treatment. There is an urgent need for therapies that people with RRMM can receive outside of academic centers, according to GSK.
Blenrep is an into-the-vein infusion and includes two components — an antibody and a drug. The antibody allows the therapy to bind to BCMA, a protein on the surface of plasma cells. This facilitates the delivery of a toxic chemical called auristatin F into the target cells, while minimizing its exposure of healthy cells.
”Blenrep is well positioned to address the unmet needs of these patients, while also providing the benefit of in-office administration in both academic and community treatment settings without complex pre-administration regimens or hospitalization,” Abdullah said.
EU and U.S. regulators previously granted conditional approval to Blenrep as a standalone therapy. After a Phase 3 trial (NCT04162210), DREAMM-3, failed to show that it outperformed standard of care therapies, CHMP recommended not renewing the conditional approval. This led GSK to withdraw Blenrep from the market. The company also removed it from U.S. markets following a request by the U.S. Food and Drug Administration (FDA).
Results of Phase 3 trials
Now, two further Phase 3 trials, DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623), are testing Blenrep with BorDex and PomDex, respectively, both studies involving three weeks of infusions. So far, results have indicated the combinations slowed RRMM disease progression.
DREAMM-7 includes 494 adults with RRMM who’d received at least one other therapy. All the participants received BorDex, with half also receiving Blenrep and a comparative group receiving Darzalex (daratumumab).
The Blenrep group went a median of 36.6 months without disease progression or death, compared with 13.4 months in the other group. The Blenrep combination also reduced risk of death by 43%.
DREAMM-8 likewise tested two combinations with PomDex, one with Blenrep and one with bortezomib (sold as Velcade and generics). All 302 participants received at least one previous line of therapy, including lenalidomide.
After a median follow-up of 21.8 months, the median progression-free survival had not yet been reached in the Blenrep group, indicating most participants hadn’t had progression. The other group went a median of 12.7 months without cancer progression or death.
As in DREAMM-7, the Blenrep group tended to have a lower chance of death, but this wasn’t statistically significant. The researchers plan to continue following up in DREAMM-8 to better understand the effects of Blenrep plus PomDex.
Based on the DREAMM-7 and DREAMM-8 results, U.K. regulators approved the Blenrep combinations, as did regulators in Japan. The FDA also agreed to review Blenrep plus BorDex and Blenrep plus PomDex.
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