# Efficacy and safety of the third-generation tyrosine kinase inhibitor Olverembatinib in relapsed and persistent minimal residual disease positive Philadelphia chromosome-positive acute lymphoblastic leukemia patients

## TL;DR

This study shows that Olverembatinib is effective and safe for treating a specific type of leukemia that does not respond well to older drugs.

## Contribution

The study demonstrates the efficacy of Olverembatinib, a third-generation tyrosine kinase inhibitor, in relapsed and MRD-positive Ph+ ALL patients.

## Key findings

- Olverembatinib achieved a 75% complete remission rate after one treatment cycle in relapsed patients.
- After two cycles, remission and molecular response rates increased to 87.5% in evaluable patients.
- The drug restored molecular remission in 90% of patients previously unresponsive to older treatments.

## Abstract

This study aimed to evaluate the efficacy of Olverembatinib in patients with relapsed and persistent minimal residual disease-positive Philadelphia chromosome-positive acute lymphoblastic leukemia.

We conducted a retrospective analysis of clinical characteristics in 22 patients diagnosed with Ph + ALL at Qilu Hospital of Shandong University and Yantai Yuhuangding Hospital between December 2018 and December 2024.

A cohort of 22 patients with Ph + ALL was enrolled in this study. Among them, 12 (54.5%) patients had relapsed Ph + ALL, while the remaining 10 patients exhibited persistent MRD positivity. In the relapsed subgroup, the CR rate following one treatment cycle reached 75.0% (9/12), with MRD-negative and MMR rates of 75.0% (9/12) and 50.0% (6/12), respectively. Upon completion of two treatment cycles in evaluable patients (n = 8), the CR, MRD-negative, and MMR rates all rose to 87.5, 87.5 and 87.5%, respectively. The patients with forfeited MMR on first or second-generation TKIs, of which the MMR rate was restored to 60.0% (6/10) after one cycle of Olverembatinib treatment, and a pleasant surprise was that their MMR rate soared to 90% (9/10) after two cycles of Olverembatinib treatment. 70% of them subsequently underwent successful hematopoietic stem cell transplantation.

The efficacy and tolerability of Olverembatinib were confirmed in patients with relapsed, MRD-positive, Ph + ALL, offering a novel therapeutic approach for these patients and making prolonged survival possible.