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J&J’s Darzalex shows ‘significant’ survival benefit in newly diagnosed multiple myeloma

Darzalex treatment regimen reduced risk of death by 32% after nearly five years follow-up

Johnson & Johnson’s CD38 monoclonal antibody (mAb) Darzalex has achieved ‘significant’ overall survival (OS) data in newly diagnosed multiple myeloma, the company revealed at the European Hematology Association 2021 virtual congress (EHA).

The data comes from the phase 3 MAIA trial, which evaluated Darzalex (daratumumab) plus Bristol Myers Squibb’s Revlimid (lenalidomide) and dexamethasone compared with Revlimid and dexamethasone alone in newly diagnosed multiple myeloma patients who were ineligible for stem cell transplant.

A prespecified interim analysis for OS found that the Darzalex treatment regimen reduced the risk of death by 32% compared with Revlimid plus dexamethasone alone, after a median follow-up of nearly five years.

The median OS had not been reached in either arm at the interim analysis, with median progression-free survival (PFS) also not reached after nearly five years.

The PFS benefit observed with Darzalex plus Revlimid and dexamethasone was also maintained, with a 47% reduction in the risk of disease progression or death.

"These latest findings from the MAIA study demonstrate the impact of this Darzalex combination regimen on long-term survival in the frontline setting, further establishing the importance of Darzalex as a backbone therapy in the treatment of multiple myeloma," said Craig Tendler, vice president, late development and global medical affairs, oncology, Janssen Research & Development.

"These results provide hope and confidence for newly diagnosed patients with multiple myeloma seeking effective treatment regimens that improve long-term outcomes and reflect our commitment to continuing to explore the full potential of Darzalex in multiple myeloma,” he added.

Longer-term follow-up analysis from the MAIA trial also found an estimated five-year OS rate of 66% with the Darzalex regimen versus 53% for Revlimid plus dexamethasone.

Meanwhile, the estimated five-year PFS rate was 53% for the Darzalex combo versus 29% for the Revlimid/dexamethasone treatment regimen.

The new data bolsters Darzalex’s position in the multiple myeloma, where it faces competition from Sanofi’s cancer treatment Sarclisa (isatuximab-irfc).

Like Darzalex, Sarclisa is designed to target the CD38 protein found on the surface of myeloma cells, inducing programmed tumour cell death – also known as apoptosis.

Sarclisa is currently approved in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of relapsed or refractory multiple myeloma who have received at least two prior therapies.

However, Sanofi is currently evaluating Sarclisa in combination with Velcade (bortezomib), Revlimid and dexamethasone in newly diagnosed multiple myeloma patients who are not eligible for transplant.

Topline results from this trial – labelled IMROZ – are expected later this year, meaning Sarclisa could potentially go on to compete with Darzalex in the first-line setting.

Article by
Lucy Parsons

15th June 2021

From: Research

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