Date: 2014-12-09
Type of
information: Presentation of results at a congress
phase: 3
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: Mylotarg® (gemtuzumab ozogamicin)
Action
mechanism:
- antibody drug conjugate. Mylotarg® (gemtuzumab ozogamicin ) is an antibody-drug conjugate (ADC) composed of a recombinant humanized IgG4, kappa antibody conjugated with a cytotoxic antitumor antibiotic, calicheamicin. The antibody portion of Mylotarg binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein found on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells.
Disease: previously untreated patients with acute myeloid leukemia
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On December 9, 2014, Pfizer announced the presentation of data from clinical studies across several hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML). Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate (ADC) Mylotarg® (gemtuzumab ozogamicin) in select adult AML populations. Research was presented at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco, December 6-9.
Oral and poster presentations focused on the efficacy of Mylotarg® in previously untreated patients with acute myeloid leukemia. Two oral presentations included:
• AML-19 (abstract #619): This investigator-led, randomized, Phase 3 study (N=237) found that MYLOTARG significantly improved overall survival (OS) in elderly patients with AML not considered fit for intensive chemotherapy, compared to best supportive care (BSC) (median 4.9 versus 3.6 months; HR: 0.69; 95 percent CI: 0.53-0.90; P=0.005). The most common grade 3 adverse events (AEs) for MYLOTARG versus BSC included infection (35.1 versus 34.3 percent), febrile neutropenia (18 versus 23.7 percent), bleeding (12.6 versus 12.3 percent), fatigue (11.7 versus 21 percent) and cardiac toxicity (6.3 versus 14 percent). The study was conducted by the European Organization for the Research and Treatment of Cancer (EORTC) and Gruppo Italiano Malattie Ematologiche dell\'Adulto (GIMEMA) leukemia groups.
• ALFA-0701 (abstract #376): This investigator-led, randomized, Phase 3 study (N=278) demonstrated a combination of MYLOTARG and a standard-of-care chemotherapy regimen (daunorubicin and cytarabine) significantly improved event-free survival (EFS) and relapse-free survival (RFS) in adult AML patients at three years, compared to induction chemotherapy alone (EFS: 31 percent versus 19 percent; HR=0.66; 95 percent CI: 0.50-0.87; median 9.7 versus 15.6 months; P=0.0026) (RFS: 38 percent versus 25 percent; P=0.006). In terms of safety, MYLOTARG patients were more likely to experience persistent thrombocytopenia (15 percent) as well as two or more serious adverse events (SAEs)(P=0.031). The study was conducted by the Acute Leukemia French Association (ALFA) in collaboration with Pfizer.
Is
general: Yes
