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Olverembatinib Treatment in Pediatric Patients With Relapsed Philadelphia-Chromosome-Positive Acute Lymphoblastic Leukemia

Treatment outcomes for children with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) remained poor despite the use of intensive chemotherapy, imatinib or dasatinib, and consolidative allogeneic hematopoietic cell transplantation. Oleverembatinib, a third-generation ABL inhibitor, was found to be highly effective and safe in adults with chronic myeloid leukemia and in some adults with relapsed or refractory Ph+ ALL. We reviewed the efficacy and safety profile of olverembatinib treatment in 6 children with relapsed Ph+ ALL and 1 with T-ALL and ABL class fusion, all of whom had previously received dasatinib or intolerance to dasatinib. The median duration of olverembatinib treatment was 70 days (range: 4-340) and the median cumulative dose was 600 mg (range: 80-3810). Complete remission with negative minimal residual level (<0.01%) was achieved in 4 of the 5 evaluable patients, 2 of whom were treated with olvermbatinib as a single agent. Safety profile in 6 evaluable patients was excellent with grade 2 extremity pain occurred in 2 patients and grade 2 myopathy of lower extremity and grade 3 fever in 1 patient each. Olverembatinib appeared to be safe and effective in children with relapsed Ph+ ALL.

 

Comments:

The study you mentioned reviewed the efficacy and safety of olverembatinib treatment in children with relapsed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). This particular type of ALL has historically had poor treatment outcomes despite intensive chemotherapy, imatinib or dasatinib therapy, and allogeneic hematopoietic cell transplantation.

The researchers evaluated olverembatinib, a third-generation ABL inhibitor, in a group of 6 children with relapsed Ph+ ALL and 1 child with T-cell ALL and ABL class fusion. These patients had previously received dasatinib or had developed intolerance to dasatinib. The median duration of olverembatinib treatment was 70 days, ranging from 4 to 340 days, and the median cumulative dose administered was 600 mg, ranging from 80 to 3810 mg.

The results showed promising efficacy and safety outcomes. Among the 5 evaluable patients, 4 achieved complete remission with negative minimal residual disease levels (<0.01%). Notably, 2 of these patients achieved remission while being treated with olverembatinib as a single agent, indicating its potential as a standalone treatment for relapsed Ph+ ALL.

Regarding safety, the study reported an excellent safety profile in the 6 evaluable patients. Two patients experienced grade 2 extremity pain, while one patient each had grade 2 myopathy of the lower extremity and grade 3 fever. Overall, these adverse events were manageable and did not compromise the potential of olverembatinib as a treatment option.

Based on these findings, the study suggests that olverembatinib is a safe and effective treatment for children with relapsed Ph+ ALL, including those who have previously received dasatinib or experienced intolerance to it. These results provide hope for improving treatment outcomes in this challenging patient population. However, it's important to note that further research and larger studies are needed to confirm these findings and establish the long-term safety and efficacy of olverembatinib in pediatric patients with relapsed Ph+ ALL.

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Bcr-Abl