Celgene Corporation Announces Post-Hoc Subgroup Analysis of Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase Ii Trial of GED-0301
May 19 15
Celgene Corporation announced that a post-hoc subgroup analysis of a double-blind, placebo-controlled, randomized, multicenter phase II trial of GED-0301 (mongersen) in patients with active Crohn's disease was presented at Digestive Disease Week (DDW) in Washington, D.C. The primary findings of the phase II trial, which enrolled 166 adult patients with active Crohn’s disease, defined as Crohn’s Disease Activity Index (CDAI) scores >220 to =400, were published in the March 19, 2015 issue of The New England Journal of Medicine. Patients in the trial were treated for two weeks with either placebo or one of three doses of GED-0301 (10 mg, 40 mg or 160 mg tablets, once daily) and then followed for an additional 10 weeks. The presentation at DDW retrospectively examined certain subgroups of patients in the trial. In the subgroup analysis, patients were grouped by disease duration (<5 years vs. =5 years), baseline CDAI score (<260 vs. =260) and baseline levels of the C-reactive protein (CRP) inflammatory marker (<3 mg/L vs. =3 mg/L). Patients in these subgroups were then analyzed for clinical remission (a CDAI score <150) and clinical response (CDAI score reduction =100 points from baseline) at weeks 2 and 4. Clinical remission rates for patients treated with GED-0301 160 mg were similar regardless of disease duration or baseline CDAI or CRP levels and were higher than those for patients on placebo (remission rates ranged from 62.5% to 75% for GED-0301 160 mg vs. 5% to 24% for placebo). These findings provide a rationale for continued evaluation of the 160 mg dose in the phase III program. For patients with a disease duration of at least five years (mean of 15.4 years), 62.5% (15/24) of those treated with GED-0301 160 mg were in clinical remission at week 2, compared with 15.4% (4/26) of those treated with placebo. Similar results were observed at week 4 (66.7% [16/24] vs. 15.4% [4/26], respectively). Clinical response rate was 70.8% (17/24) with GED-0301 160 mg, compared with 19.2% (5/26) with placebo, at week 2 and 79.2 % (19/24) versus 26.9% (7/26), respectively, at week 4. For patients with baseline CDAI of at least 260 (median of 303), 62.5% (10/16) of those treated with GED-0301 160 mg were in clinical remission at week 2, compared with 13.6% (3/22) for placebo and 75.0% (12/16) versus 4.5% (1/22), respectively, at week 4. Clinical response rate was 87.5% (14/16) with GED-0301 160 mg versus 22.7 % (5/22) for placebo at week 2 and 87.5 % (14/16) versus 22.7 % (5/22), respectively, at week 4. Similar results were observed for patients with baseline CRP of at least 3 mg/L (about 60% of patients in the trial). At week 2, 71.4% (20/28) of patients in the GED-0301 160 mg group achieved clinical remission compared with 24.0% (6/25) in the placebo group. At week 4, similar results were observed (75.0% [21/28] vs. 12.0% [3/25]). In the GED-0301 160 mg group, 60.7% (17/28) and 64.3 % The rates of patients with at least one adverse event (AE) were 49%, 62% and 49% for the GED-0301 10 mg, 40 mg and 160 mg doses, respectively, and 67% for placebo. The most commonly reported AEs in the GED-0301 treatment groups were abdominal pain (10-12%), Crohn’s disease worsening (10-15%), urinary tract infection (5-15%) and CRP increase (5-9%). The rates of serious AEs in the GED-0301 groups were 7%, 2% and 2% for 10 mg, 40 mg and 160 mg dose, respectively, compared with 2% for placebo.
Celgene Corporation Seeks Acquisitions
May 7 15
Celgene Corporation (NasdaqGS:CELG) is seeking acquisitions. Jackie Fouse, President, Global Hematology and Oncology, said, "We have also got what I like to call a little M&A pipeline within a pipeline, so to speak, because we have options to acquire many of our partner companies." Fouse added, "I think the possibility for us to do what we probably characterize as bolt-on acquisitions is still there."
Celgene Corporation Announces Results from A Pre-Specified Secondary Endpoint Analysis of MDS-005
May 1 15
Celgene Corporation announced results from a pre-specified secondary endpoint analysis of MDS-005, a multicenter, randomized, placebo controlled phase III study of REVLMID (lenalidomide) compared with placebo in patients with non-del-5q myelodysplastic syndromes (MDS). The analysis was presented during the 13th International Symposium on Myelodysplastic Syndromes. Results from MDS-005 were originally presented at the 2014 American Society of Hematology annual meeting and reported that significantly more patients treated with lenalidomide achieved red-blood-cell-transfusion independence (RBC-TI) of at least 56 days compared with placebo (26.9%, [43/160 patients] vs. 2.5%, [2/79 patients]. In the United States, REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand. REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. In addition, REVLIMID is approved in the United States for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. U.S. Regulatory Information for REVLIMID REVLIMID (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM) REVLIMID is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1 "risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities REVLIMID is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib REVLIMID is not indicated and not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.