Naval G. Daver, MD, discusses a phase 1b trial evaluating the efficacy of margolimab and azacitidine combination for patients with acute myeloid leukemia.
Naval G. Daver, MD, associate professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, discusses a phase 1b trial evaluating the efficacy of margolimab and azacitidine (Vidaza) combination for patients with acute myeloid leukemia (AML).
There were 29 patients in the trial and 72% of those patients had poor-risk cytogenetics. Almost half of the patients had a TP53 mutation. The median age was 74, and there was a patient all the way up to 89 years of age, so this is definitely a population that will not routinely be considered for intensive induction therapy, according to Daver.
The overall response rate was 64% in these patients. This included a complete remission (CR) and CR with incomplete hematologic recovery (CRi) of about 56%, as well as some partial responses. Daver believes this is encouraging because azacitidine as a single agent has been studied in multiple phase 2 and 3 trials for AML, and the CR rate has been around 15% to 18% while the CR/CRi rate is around 30% to 35%. This trial had a CR rate of about 40% and CR/CRi of about 55%.
Daver says it was especially interesting that in the 12 patients with TP53-positive AML, although there were small numbers and there needs to be more data to be confident with the findings, there was a CR/Ci rate of 75% and duration of response had not been reached with a median follow-up of about 8 and a half months. Comparatively, the most effective other therapy in the setting right now of azacitidine and venetoclax (Venclexta) has a CR/CRi rate of 45% to 50% and the duration of response is around 4 and a half to 5 months.