In November 2022, GSK began the process of withdrawing Blenrep’s U.S. marketing authorization after the phase 3 DREAMM-3 trial failed to show an overall survival benefit compared to standard therapy. But GSK has signaled its hope that the B-cell maturation antigen (BCMA) antibody-drug conjugate could have a new lease on life with new data from the phase 3 DREAMM-7 study.
Blenrep shows promise in DREAMM-7 study as combination therapy
The study revealed that combining Blenrep (belantamab mafodotin) with the proteasome inhibitor bortezomib and the steroid dexamethasone (BorDex) improved progression-free survival by 59% compared to a combination of Darzalex (daratumumab) and BorDex. Additionally, progression-free survival was extended to 36.6 months with Blenrep plus BorDex, versus only 13.4 months with the daratumumab regimen. Finally, the DREAMM-3 study found an early but strong and clinically meaningful trend toward improved overall survival favoring the Blenrep combination therapy, with a 43% reduction in the risk of death compared to standard treatment.
In a news release, Hesham Abdullah, senior vice president, global head oncology, R&D, GSK, said the company would share the data with global health authorities.
Multiple myeloma treatment options expanding
The prognosis for multiple myeloma is generally improving but the cancer is often considered incurable. For all stages, the 5-year U.S. relative survival rate for multiple myeloma is roughly 58%.
Treatment for the cancer often involves a combination of therapies including chemotherapy, corticosteroids, stem cell transplantation, and novel agents such as proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies.
Against that backdrop, Big Pharma companies ranging from J&J to Bristol Myers Squibb and GSK have sought to advance the standard of care in recent years. J&J won approval for teclistamab (Tecvayli), a BCMA-targeted bispecific antibody, in October 2022 for heavily pretreated multiple myeloma. Bristol Myers Squibb won approval for Abecma, a BCMA-directed CAR T-cell therapy, in March 2021 for relapsed/refractory multiple myeloma. GSK has felzartamab, a BCMA-targeted antibody-drug conjugate, in phase 3 trials for relapsed/refractory multiple myeloma.
It’s been something of a winding road for Blenrep. In 2019, in August, GSK revealed positive headline data from the pivotal DREAMM-2 study. FDA granted priority review for Blenrep for patients with relapsed or refractory multiple myeloma in January 2020. In August of that year, FDA granted accelerated approval of Blenrep for that indication as a monotherapy for patients who had received at least four earlier therapies. The approval stipulated that prior treatments include an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Filed Under: clinical trials, Drug Discovery, Hematology, Oncology