Date: 2014-12-09
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6-9 in San Francisco, CA
Company: Pfizer (USA - NY)
Product: inotuzumab ozogamicin
Action
mechanism: antibody drug conjugate. Inotuzumab ozogamicin is an antibody drug conjugate (ADC) comprised of a monoclonal antibody targeting CD22,a cell surface antigen expressed on approximately 90 percent of B-cell malignancies, linked to a cytotoxic agent, calicheamicin. CMC-544 is the product of a collaboration between Wyeth and UCB-Celltech.
Disease: acute lymphoblastic leukemia (ALL)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On December 9, 2014, Pfizer announced the presentation of early- and late-stage data from clinical studies across several hematologic malignancies, including a Phase 2 study (N=35) (abstract #2255) of inotuzumab ozogamicin,at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco, December 6-9. Data of the study demonstrate clinical activity in relapsed/refractory (R/R) adult acute lymphoblastic leukemia patients (NCT01564784). The majority of patients (69 percent; 95 percent CI: 50.7-83.2) achieved a complete response (CR) or CR without complete neutrophil count or platelet recovery (CRi). In addition, 75 percent of CR+CRi patients achieved minimal residual disease (MRD) negativity, an indicator of remission. Common grade ?3 AEs included thrombocytopenia (34 percent), neutropenia (20 percent) and febrile neutropenia (20 percent).The randomized, Phase 3 INO-VATE ALL trial is ongoing in a similar patient population, with top-line results expected in 2015. Additionally, an investigator-led Phase 1/2 study (abstract #794) demonstrated that inotuzumab ozogamicin added to low intensity chemotherapy (cyclophosphamide, dexamethasone, methotrexate and cytarabine) had clinical activity in previously untreated older patients (?60 years) with ALL. In the study, 96 percent of evaluable patients (N=26) achieved CR or CR without complete platelet recovery (CRp) at the 13-month follow-up. All patients who achieved CR+CRp also achieved MRD negativity. Grade 3 and/or 4 toxicities included infections (85 percent), prolonged thrombocytopenia (65 percent), hyperglycemia (44 percent), increased bilirubin (22 percent), intracranial hemorrhage (15 percent), increased amino alanine transferase (ALT) (11 percent), hematuria (7 percent), headache (4 percent), cognitive disturbance (4 percent), ascites (4 percent) and diarrhea (4 percent). The study was conducted by The University of Texas MD Anderson Cancer Center.
