Johnsons and Johnson’s announced that their clinical trial for a combination therapy can delay the progression of multiple myeloma. The two regimens that they used were utilized for the treatment of blood cancer. The company hopes that this new combo drug will open doors for wider application of their lead drug, Darzalex.
Last November, Darzalex got FDA approval for the treatment of patients who had three prior treatments for myeloma, a cancer infection that fights white blood cells. Darzalex is an infused medicine with a price list of $135,000 for a one year of full treatment. It blocks CD38 a protein which is found in myeloma cells. It was approved after two small clinical trials showed that it can reduce the size of the tumors for almost 29% of the patients.
A large stage trial involving 498 patients participated in the experimental trial for multiple myeloma. The result of the trial was released last Sunday. There were two groups in the treatment; one group received a steroid called dexamethasone and Velcade from Takeda Pharmaceutical Co. while the second group received Darzalex and a combination of the two drugs.
Results also showed that 19% of patients in the Darzalex regimen showed no any further sign of disease as compared with those taking Velcade and dexamethasone. There was an 83% reduction in those taking Darzalex Regimen as compared with the 63% in the two drug combination.
The Darzalex group was not able to meet the median time to disease progression as compared with the 7.2 months of the two-standard drug.
The trial was stopped in March after the results showed statistically significant result from the Darzalex regimen.
The findings were presented at the American Society of Clinical Oncology Annual Meeting in Chicago.
The study’s head researcher, Dr. Antonio Palumbo noted in an interview that the Darzalex regimen has an overall toxicity that is similar from the two standard treatments. Thus, the J &J drug may be considered as a second-line treatment in combination with dexamethasone and Velcade.
The noted side effects of the combo therapy are anemia, diarrhea, and low blood platelets.
Palumbo who has also the Melanoma Unit Chief, at the University of Torino, Italy mentioned that they are expecting another late-stage study of Darzalex which is expected to be out later this month. The team is expecting a similar result from their earlier clinical trials.
In this trial, the patients received Darzalex with Celgene Corp lead brand Revlimid or lenalidomide, plus dexamethasone treatment.
Johnsons and Johnsons Global Head of Hematology, Mark Widgust, shared that the company is hoping that the trial will allow Darzalex in the early treatment of myeloma with the other standard medicines.
According to the National Cancer Institute, there are 26,850 cases of multiple myeloma are diagnosed in the United States. The life expectancy of patients with multiple myeloma is around four years.
Johnson and Johnson are trying to test their lead drug to other cancer conditions to maximize its therapeutic potential. If they are able to prove that the drug can be used in another disease entity, it means having a new area of market potential that would eventually increase their sales. It will also make their drug more competitive than the other brand, since it can be used in other disease conditions.