Survival better with Blenrep combo than Darzalex for R/R myeloma

Lower risk of death reported in Phase 3 trial of the two combination therapies

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Two hands, a stethoscope and a handful of pills surround a graph showing positively trending data from a clinical trial.

A combination therapy using Blenrep (belantamab mafodotin) was more effective at extending life in people with relapsed or refractory multiple myeloma than a combo treatment using Darzalex (daratumumab).

That’s according to results from the Phase 3 clinical trial DREAMM-7 (NCT04246047) announced by Blenrep’s developer, GSK.

“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 and global head of oncology research and development at GSK, said in a company press release.

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Global DREAMM-7 trial of combo treatments enrolled nearly 500 patients

The global DREAMM-7 clinical trial enrolled nearly 500 people with relapsed or refractory multiple myeloma. Participants were randomly assigned to receive Blenrep or Darzalex in combination with bortezomib and dexamethasone (BorDex).

Results showed that the risk of death was significantly lower in patients given Blenrep, according to GSK. The company didn’t provide further details, noting that full trial results will be presented at the annual meeting of the American Society of Hematology, set for Dec. 7-10 in San Diego.

“This is a statistically significant and clinically meaningful advancement for patients and potentially transformative for treatment,” Abdullah said. “We look forward to sharing these data with health authorities and presenting the full results at next month’s American Society of Hematology Annual Meeting.”

The Blenrep plus BorDex combination currently is being considered for approval by authorities in the European Union and Japan. GSK also has applied for the combination’s approval in the U.S., Switzerland, the U.K., and Canada.

Blenrep previously was granted conditional approval as a monotherapy (on its own) for heavily treated myeloma patients in the U.S. and Europe. However, following disappointing results from a confirmatory clinical trial, authorities in both markets pulled approval for the monotherapy.

GSK now is developing Blenrep as a combination therapy, to be used with BorDex or with pomalidomide plus dexamethasone (PomDex). The latter is being tested in relapsed/refractory multiple myeloma in a separate Phase 3 study called DREAMM-8 (NCT04484623).

In addition to these trials in people with relapsed or refractory disease (meaning the cancer has been resistant to treatment or returned following an initial response to treatment), GSK also reported plans to launch a trial of Blenrep combination treatments in newly diagnosed multiple myeloma patients who aren’t eligible for a stem cell transplant, which is a common first-line therapy. This study is expected to kick off before the end of this year, the company said.