Darzalex Should Be a New Standard of Care, Say Study Authors

June 7, 2016
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

J&J’s Darzalex, in combination with two older drugs, was found to significantly extend progression-free survival in patients with relapsed refractory multiple myeloma.

Johnson & Johnson’s Janssen arm announced on June 5, 2016 during the American Society of Clinical Oncology (ASCO) meeting that their drug Darzalex (daratumumab) significantly extended progression-free survival in patients with multiple myeloma when combined with a regimen of bortezomib (trade name Velcade) and dexamethasone. The three-drug combo performed better than treatment with the older, two-drug combination (Velcade and dexamethasone) alone in patients with at least one prior line of therapy.

In a Phase III trial of nearly 500 patients, the three-drug combo (in the study CASTOR) significantly increased the overall response rate from 63% for the standard of care to 83%. Although the median progression-free survival has not yet been met in the new trial, it already met the median progression-free survival point of the current standard of care (7.16 months).

According to an email from Craig Tendler, vice-president, late-stage development and global medical affairs for oncology, hematology and supportive care at Janssen Research & Development, treatment options for patients with relapsed or refractory multiple myeloma include hematopoietic cell transplantation (HCT) or a trial of a new regimen-and Revlimid plus dexamethasone or Velcade plus dexamethasone are two common treatment options for relapsed or refractory multiple myeloma. Despite these options, there is currently no standard of care to treat adult patients with relapsed and refractory multiple myeloma, Tendler points out. “Proteasome inhibitors (PIs) and immunomodulatory drugs have improved outcomes in patients with multiple myeloma. Despite these advances, prognosis for patients with relapsed or refractory multiple myeloma remains poor, particularly for those who have relapsed after PI and immunomodulatory treatment.” Researchers conducting the CASTOR study noted in an ASCO abstract that "the addition of Darzalex to Velcade and dexamethasone should be considered a new standard of care for relapsed or refractory multiple myeloma patients currently receiving Velcade and dexamethasone alone."

Additional data on Darzalex in combination with lenalidomide (Revlimid) and dexamethasone in the same patient population will be featured during the upcoming European Hematology Association meeting in Copenhagen. In May 2016, Genmab announced the Phase III results of the POLLUX trial, showing that Darzalex in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone prolonged progression-free survival.

Darzalex was approved by FDA in November 2015 as a single-agent treatment in multiple myeloma patients who received at least three prior lines of therapy. Competitors to Darzalex could include Empliciti (elotuzumab), Ninlaro (ixazomib), Pomalyst (pomalidomide), Kyprolis (carfilzomib), and Farydak (panobinostat).

According to a recent Wall Street Journal article, there are concerns that multiple oncology drugs and biologics used in combination could have the potential to push drug spending budgets to even further heights. The publication reported that the cost of Darzalex alone costs about $134,550 for the first year of treatment and $76,050 each subsequent year. Although dexamethasone is available as a generic, Takeda’s Velcade is still protected by a patent, likely making it fairly expensive as well. When asked about the price of Darzalex, Tendler says the company “cannot speculate on price for an unapproved indication, including the use of Darzalex in combination.”

Sources: J&J, WSJ, ASCO