Darzalex combo makes strong Phase 3 showing in multiple myeloma

pharmafile | June 4, 2019 | News story | Manufacturing and Production, Research and Development ASCO 2019, Cancer, Janssen, darzalex, multiple myeloma, pharma 

Janssen joined its contemporaries at the 55th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in the release of new data in the field of new cancer treatments.

At the event, the company lifted the curtain on Phase 3 study findings for Darzalex (daratumumab) plus bortezomib, thalidomide and dexamethasone (VTd) before and after autologous stem cell transplantation (ASCT) in the treatment of newly diagnosed multiple myeloma.

The study, a collaboration between Intergroupe Francophone du Myelome (IFM), the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Research & Development, showed that patients using the combo therapy showed higher response rates and longer progression-free survival (PFS) compared to VTd alone.

In the first part of the two part CASSIOPEIA study, the Darzalex/VTd combo saw a “significantly higher” rate of stringent complete response at 29% compared to 20% with VTd alone, while the combo scored an 18-motnh PFS rate of 93% compared to 85% for VTd alone. 83% achieved a very good partial response or better with the combo compared to 78%, while 39% achieved a complete response or better compared to 26%.

“CASSIOPEIA is the first study to investigate the clinical benefit of daratumumab in combination with a standard of care treatment regimen in patients with newly diagnosed multiple myeloma undergoing autologous stem cell transplant,” said Dr Philippe Moreau, CASSIOPEIA primary investigator and Head of the Hematology Department at the University Hospital of Nantes in France. “There is a need for new treatment options for newly diagnosed patients, potentially including this combination therapy with daratumumab. This study adds to the growing body of evidence for daratumumab in the frontline setting.”

Dr Patrick Laroche, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead at Janssen-Cilag France, also remarked: “We are incredibly excited by these results, which highlight the benefit daratumumab could offer to transplant-eligible newly diagnosed multiple myeloma patients, and we continue to follow patients closely in part two of the study. These data formed the basis for recent regulatory submissions to both the European Medicines Agency and US Food and Drug Administration, seeking to expand the current indication for daratumumab. We are now working closely with health authorities to bring this important combination to patients who need new options, as soon as possible.”

Matt Fellows

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