Initial findings from a phase 3 trial demonstrate that Blenrep (belantamab mafodotin) plus Velcade (bortezomib) and dexamethasone significantly reduced the risk for death compared with Darzalex (daratumumab) plus Velcade and dexamethasone in the second-line or later treatment of relapsed or refractory multiple myeloma.
In particular, a press release from GSK, the manufacturer of the antibody-drug conjugate, Blenrep, announced that the phase 3 DREAMM-7 trial met its secondary end point, meaning that the Blenrep combination treatment improved overall survival (OS) in patients with relapsed or refractory multiple myeloma.
“The overall survival results from the DREAMM-7 trial underscore the potential for this Blenrep combination to extend the lives of patients with relapsed/refractory multiple myeloma,” Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D at GSK, said in the release. “This is a statistically significant and clinically meaningful advancement for patients and potentially transformative for treatment.”
Glossary
Overall survival (OS): the time either at diagnosis or at treatment initiation when a patient with cancer is still alive.
Progression-free survival: the time from randomization until progressive disease or all-cause death.
Duration of response: how long treatment keeps cancer from growing or spreading.
Minimal residual disease negativity rate: how many patients who no longer have detectable cancer cells in their bodies after treatment.
Overall response rate: the percentage of patients who experience a significant reduction or complete disappearance of their tumor from treatment.
The DREAMM-7 trial includes 494 patients with relapsed or refractory multiple myeloma who were previously treated with at least one line of therapy and whose disease progressed during or after their most recent therapy, according to the release. Patients were randomly assigned to receive either Blenrep in combination with Velcade and dexamethasone, or Darzalex plus Velcade and dexamethasone.
As noted in the trial’s ClinicalTrials.gov listing, researchers have several areas of interest, one of which is progression-free survival. In addition to OS, other secondary end points included duration of response, minimal residual disease negativity rate, overall response rate and several quality-of-life measures, among others.
Results from this analysis will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting in December 2024.
Blenrep was approved by the Food and Drug Administration in August 2020 for the treatment of patients with relapsed or refractory multiple myeloma who previously received four therapies. This was the first BCMA therapy to be approved worldwide. Of note, BCMA therapies are a type of immunotherapy used to treatment multiple myeloma, which targets the BCMA protein found on most multiple myeloma cells.
There are several trials that are part of the DREAMM clinical development program within GSK that are evaluating the potential of Blenrep in earlier lines of treatment and combined with other novel therapies and standard-of-care therapies, according to the release. For example, the DREAMM-8 trial is comparing Blenrep plus Pomalyst (pomalidomide) and dexamethasone with Velcade. Findings from this trial were presented at the 2024 ASCO Annual Meeting and demonstrated that patients with relapsed/refractory multiple myeloma treated with the Blenrep combination tended to live longer without disease worsening compared with treatment with Velcade.
“Taken together with the results of phase 3 DREAMM-7, which combined [Blenrep] with [Velcade] and dexamethasone, these data highlight the potential of [Blenrep]-containing triplets to address an unmet need for novel regimens to treat patients with myeloma and first relapse,” study investigator Dr. Suzanne Trudel, a clinician scientist at Princess Margaret Cancer Centre, said in the presentation.
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