Highlights From ASH 2015: Data Presented From 3 Phase 2 Trials Evaluating Blinatumomab (Blincyto®) in Adults With Acute Lymphoblastic Leukemia
Although rare, acute lymphoblastic leukemia (ALL) is a rapidly progressing cancer of the blood and bone marrow. No broadly accepted standard treatment regimen currently exists for adults with relapsed or refractory ALL beyond chemotherapy, and the overall median survival for these patients is only 3 to 5 months. In the up to 30% of adults with ALL who are Philadelphia chromosome‒positive (Ph+), the response to standard treatment is typically poor, duration of remission is short, and survival rate is low.
Blinatumomab (Blincyto®) is a first-in-class bispecific T-cell engager, or BiTE, that has been approved by the Food and Drug Administration for patients with relapsed or refractory Philadelphia chromosome‒negative (Ph-) ALL of B-cell lineage. Data from 3 Phase 2 trials were presented at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH) held in Orlando, Florida, that support the safety and efficacy of blinatumomab in adults with ALL.
A Phase 2 single-arm confirmatory, multicenter study―BLAST―was conducted in adults with B-cell precursor ALL and minimal residual disease (MRD). MRD is the presence of leukemia blast cells below the limits of detection using standard assessment. Patients with no detectable MRD have a lower risk of relapse compared with those with persistent or recurrent MRD. Results of this study showed that blinatumomab monotherapy provided clinically meaningful relapse-free survival (RFS) in patients with persistent or recurrent MRD. The median RFS was 18.9 months.
The 2 additional presentations showed the potential use of blinatumomab in a high-risk subpopulation with relapsed or refractory Ph+ B-precursor ALL and in a subset of patients with relapsed or refractory Ph- ALL after allogeneic hematopoietic stem cell transplantation, who typically have poor outcomes with current treatments.
Neurologic toxicities occurred in 50% of patients receiving blinatumomab in clinical trials and were severe in 15% of these patients. About 25% of patients had serious infections, some of which were life-threatening or fatal.
About the Connexion Healthcare Oncology Center of Excellence
Connexion Healthcare is a full-service global provider of strategic medical and scientific communications with decades of experience providing exceptional service to the pharmaceutical industry. We provide services through 2 Centers of Excellence—Oncology and Rare Disease—and possess core expertise in these therapeutic areas and their marketplaces.
Connexion Healthcare’s Oncology Center of Excellence offers executive talent with decades of experience in the pharmaceutical industry. Our medical directors have conducted oncology research at leading institutions and major pharmaceutical companies. Our account leads have years of project execution expertise, and our medical editors are versed in the language of oncology. Our design leads are tops in their fields and ensure that your objectives are met effectively and even surpassed in an industry-eloquent and compliant manner. Our team works with you to conceive a strategy and execute communications through your product’s lifespan – from drug discovery through market launch and beyond. With particular expertise in phase 2 through postlaunch, we will engage with you wherever you are in development and whenever you need us.
For further information regarding the Oncology Center of Excellence at Connexion Healthcare and how we can develop oncology communications to differentiate therapies by their unique attributes, contact:
Larry Lunak, Senior Vice President
Val Sudakin, PhD
Hematology/Oncology Scientific Services