In an updated analysis of a single-center phase II trial reported in the Journal of Clinical Oncology, Hagop Kantarjian, MD, and colleagues found that the simultaneous combination of ponatinib and blinatumomab continued to be associated with good outcomes in newly diagnosed patients with Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL).
Hagop Kantarjian, MD
Study Details
In the initial report from the study, 40 patients at The University of Texas MD Anderson Cancer Center received blinatumomab beginning at 9 µg daily via continuous infusion on days 1 to 4 of course 1 and then 28 µg daily via continuous infusion on days 5 to 28 in a 4-week-on, 2-week off schedule for up to five courses. Ponatinib was given at 30 mg/d during induction and was to be continued for at least 5 years. Among the 40 patients, complete molecular response was achieved in 87%, and the 12-month overall survival rate was 95%.
The current extended report includes findings from 60 patients receiving the regimen, with a median follow-up of 24 months.
Key Findings
Among 60 patients with a median 24-month follow-up (range = 9–67+ months), complete molecular response was achieved in 87%, including 67% at the end of course 1. Measurable residual disease–negative status was achieved in 98%, including 45% at the end of course 1.
A total of two patients underwent hematopoietic stem cell transplantation (HSCT). Relapse occurred in seven patients, including systemic disease in two; isolated central nervous system relapse in four; and extramedullary Ph-negative, CRLF2-positive pre-B ALL in one.
Estimated 3-year rates were 91% for overall survival and 77% for event-free survival.
Adverse events led to the discontinuation of blinatumomab in three patients and to the discontinuation of ponatinib in nine patients.
The investigators concluded: “…[T]he simultaneous combination of ponatinib and blinatumomab is a highly effective and relatively safe nonchemotherapy regimen. This regimen also reduces the need for intensive chemotherapy and HSCT in first remission in the majority of patients.”
Dr. Kantarjian, of the Department of Leukemia, The University of Texas MD Anderson Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by Takeda Oncology and Amgen. For full disclosures of the study authors, visit ascopubs.org.
