Celgene (CELG) Announces Various Cancer Data at ASH 2018
Celgene CorporationCELG has presented data from several cancer studies at the annual meeting of American Society of Hematology (ASH), which was held in San Diego, CA.
Share price of the company has decreased 30.8% year to date compared with the industry ‘s decline of 14.6%.
The company, along with its partner Acceleron Pharma Inc. XLRN , announced results from a phase III study (BELIEVE) evaluating their pipeline candidate luspatercept for the treatment of adults with beta-thalassemia-associated anemia who require regular red blood cell (RBC) transfusions.
The study’s primary endpoint was the treatment’s erythroid response, defined as a greater than or equal to 33% reduction in RBC transfusion burden during weeks 13-24 compared to the baseline 12-week interval prior to randomization. The study met the primary endpoint, demonstrating that luspatercept may help patients reduce their dependence on red blood cell transfusions.
The two companies also announced data from phase III MEDALIST study evaluating the efficacy and safety of luspatercept to treat patients with ring sideroblast (RS+) myelodysplastic syndromes (MDS)-associated anemia who require RBC transfusions and who had failed, were intolerant to or ineligible for erythropoietin therapy. The study data demonstrated that treatment with luspatercept led to statistically significant increased red blood cell transfusion independence in the above-mentioned patients compared to placebo.
The study demonstrates the potential of luspatercept to provide a meaningful treatment option for lower-risk RS+ MDS patients who suffer from severe anemia, resulting in red blood cell transfusion dependence. The companies are planning regulatory application submissions of luspatercept in the United States and Europe in the first half of 2019.
The company also announced results of the phase III AUGMENT study, which showed that Revlimid (lenalidomide) in combination with Roche’s RHHBY Rituxan led to superior progression-free survival (PFS) in patients with relapsed/refractory indolent lymphoma compared to patients who received rituximab plus placebo (R-placebo). The median PFS was 39.4 months for patients treated with Revlimid+Rituxan and 14.1 months for those treated with R-placebo.
The company will file an application for the approval of Revlimid for the treatment of relapsed/refractory indolent non-Hodgkin’s lymphomas, as a combination therapy, in the first quarter of 2019.
Celgene and its partner bluebird bio, Inc. BLUE announced initial data from the ongoing phase I study of bb21217 (CRB-402), an investigational next-generation anti-BCMA CAR T cell therapy, being studied in patients with relapsed/refractory multiple myeloma.
Of the 12 heavily pre-treated patients who received bb21217, 83% (n=10) achieved an objective clinical response. The early safety results depicted manageable findings and were consistent with known toxicities of CAR T therapies. The ongoing phase 1 CRB-402 study is assessing a higher dose of bb21217. bb21217 is bluebird bio’s lead investigational anti-BCMA CAR T therapies, being developed in collaboration with Celgene.
Celgene announced encouraging initial data from the dose-escalation part of an ongoing phase I/II study of lisocabtagene maraleucel (JCAR017), in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), including those with cytogenetic features of high-risk disease, who were previously treated with ibrutinib.
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