J&J myeloma drug, in combo regimen, delays worsening of the disease

[June 06, 2016]  By Ransdell Pierson

(Reuters) - Johnson & Johnson's therapy for advanced multiple myeloma sharply reduced the risk of disease progression when taken with two standard treatments for the blood cancer, according to research the company hopes will pave the way for wider use of the treatment.

The drug, Darzalex, received U.S. approval in November for use by itself among patients who had received at least three prior treatments for myeloma, a cancer of infection-fighting white blood cells.

Data from a late-stage trial involving 498 patients who had previously undergone one or more myeloma treatments was released on Sunday. In the study, one group received Takeda Pharmaceutical Co's Velcade and the steroid dexamethasone, while the other group received Darzalex in combination with those two drugs.

After more than seven months, 61 percent fewer patients taking the Darzalex combination experienced a worsening of their disease compared with those taking the standard two-drug regimen, meeting the trial's main goal. The median time to progression of disease has not yet been reached for the Darzalex group, compared with 7.2 months for patients taking the two-drug combo.

The study was stopped in March after an independent data monitoring committee found the Darzalex regimen showed a statistically significant benefit.

Some 19 percent of patients in the Darzalex group showed no further sign of disease, versus 9 percent of those taking Velcade and dexamethasone. Significant disease reduction was seen in 83 percent taking the Darzalex regimen, versus 63 percent in the two-drug combination.

The findings were presented at the annual meeting of the American Society of Clinical Oncology, in Chicago.

The infused medicine, which has a list price of $135,000 for the first full year of treatment, blocks the CD38 protein found on myeloma cells. It was approved based on favorable data from two smaller trials, including a study in which tumors shrank in 29 percent of patients.

Dr. Antonio Palumbo, the study's lead researcher, said in an interview that overall toxicity in the Darzalex regimen was similar to that seen with the two standard treatments. That may help the J&J drug become a second-line treatment, in combination with Velcade and dexamethasone, he said.

The most common side effects for both drug combinations included low blood platelets, diarrhea and anemia.

Palumbo, melanoma unit chief at the University of Torino, Italy, said data from another late-stage study of Darzalex is expected later this month and will probably mirror strong results seen in his own study.

In that trial, patients received Darzalex in combination with Celgene Corp's leading Revlimid (lenalidomide) treatment and with dexamethasone.

Mark Wildgust, global head of hematology at J&J, said the company hopes the trial results will allow it to market Darzalex as an earlier treatment, and in combination with standard medicines.

The National Cancer Institute estimates there are 26,850 new cases of multiple myeloma each year in the United States. The average life expectancy is four years.

(Reporting by Ransdell Pierson; Editing by Leslie Adler)

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