released the results from a series of clinical studies Monday showing that two of its drugs appear to be beneficial to patients fighting the blood cancer multiple myeloma.
Supplemental data from a clinical study of Celgene's Thalomid, a leprosy drug that was recently approved in the U.S. for treating multiple myeloma, showed that it extended the lives of patients with the disease. Patients also went longer before their disease progressed while taking the drug, which was given in combination with the oral steroid dexamethasone.
For a continuing study of 470 patients comparing dexamethasone with or without Thalomid, researchers are still waiting to determine the overall survival time for patients on Thalomid. Those who only took dexamethasone lived 25.2 months.
Also, patients on dexamthasone alone went a median 8.1 months before their disease got worse, but researchers still haven't been able to establish how much time would pass before the disease progressed in patients on Thalomid.
Celgene released data from another study that measured the survival of patients taking Thalomid as a part of a combination with the chemotherapy drug melphalan and the steroidal anti-inflammatory drug prednisone. The trial compared the triplet with just melphalan and prednisone, as well as against stem-cell transplantation.
In that study, overall survival times reached a median of 54 months in the patients receiving Thalomid, vs. 32 months for those on melphalan and prednisone, and 38.6 months for those who had transplantation. According to a review by an independent data-monitoring committee, patient enrollment was halted because of the superiority of the regimen that included Thalomid, Celgene said.
Yet another trial was designed to study the effects of adding Revlimid to melphalan and prednisone in treating elderly patients with newly diagnosed multiple myeloma. The study found that, after a 9.6-month follow-up, patients saw a response to the drug and their disease stopped getting worse after seven cycles of treatment. Four different dose levels were tested in the trial.
Celgene also reported results from a trial of Revlimid in previously treated multiple myeloma patients. According to those results, patients who received Revlimid lived a median 29.6 months, compared with 20.2 months for patients on dexamethasone alone. The median time before the disease worsened was 11.1 months, vs. 4.7 months for patients only on dexamethasone.
Patients were heavily treated for the disease before joining the trial, with many having failed three or more rounds of therapy with other drugs. More than 50% had also undergone stem-cell transplantation.
Both Thalomid and Revlimid are based on thalidomide, which was first used as a sedative and to treat morning sickness in pregnant women. The drug was pulled from the market after being linked to severe birth defects, and it didn't reappear for roughly four decades, until 1998, when Thalomid was approved by the Food and Drug Administration to treat leprosy.
While Revlimid is considered safer than Thalomid, Celgene warns that neither drug should be taken during a pregnancy. Revlimid is already approved to treat transfusion-dependent anemia stemming from certain types of myelodysplastic syndromes, and it's under FDA review for multiple myeloma. A decision is expected from the agency by June 30.
Celgene's shares were up 2 cents to $44 Monday. The stock is just below its 52-week high of $44.74.
The data from the clinical trials were presented at the annual meeting of the American Society of Clinical Oncology in Atlanta.