Max S. Topp, MD
Data from 2 early-stage trials of bispecific T-cell engager (BiTE) antibody constructs in relapsed/refractory hematologic malignancies demonstrated antitumor activity and early evidence of tolerability, investigators reported at the 2018 ASH Annual Meeting.
Infections were observed in 12 of 42 patients; 3 were grade 2, 7 were grade 3. Pneumonia (7%) and central line infections (7%) were the most common serious infections. One patient developed adenovirus infection and another developed aspergillus/influenza that led to death, neither of which were deemed to be related to the study drug. Two other patients died due to progressive disease. In December 2018, the FDA granted a fast track designation to AMG 420 based on the results from this dose escalation study. The fast track process is designed to facilitate the development and expedite the review of drugs that fill an unmet medical need for treatment of serious conditions.
AMG 330: Anti-CD33 BiTE
AMG 330 was evaluated in a multicenter phase I dose escalation study of 40 adults with relapsed/refractory AML with >5% blasts in their bone marrow. CD33 is expressed in about 99% of patients with AML, explained lead investigator Farhad Ravandi, MD, from MD Anderson Cancer Center in Houston.
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