How effective is bosutinib/bosutinib?

Bosutinib/Bosutinib, as a new type of tyrosine kinase inhibitor, is mainly used to treat chronic myelogenous leukemia (CML). Especially for patients who have poor response to other treatment options, its therapeutic effect has attracted widespread attention and research. Studies have shown that bosutinib can effectively reduce the proportion of white blood cells with Philadelphia chromosome, which makes it an important treatment option for patients with Philadelphia chromosome-positive (Ph+) CML.

In a major clinical study,bosutinib was evaluated in 570 patients with Ph+ CML who had previously received at least one tyrosine kinase inhibitor (TKI). Of these patients, 52 were considered to have unmet medical needs, primarily due to disease resistance or inability to use other TKIs due to severe side effects. Among these 52 patients, 36 were patients with chronic phase CML, and 16 were patients with accelerated phase or blast crisis CML. The primary efficacy endpoint of the study is the patient's "major cytogenetic response" (CCyR) after 6 months of treatment with bosutinib, which is a reduction in the proportion of white blood cells with the Philadelphia chromosome to less than 35%.

The study results showed that 18 of 36 patients with chronic phase CML achieved major cytogenetic responses. Of the 16 patients with advanced CML, 7 also showed significant responses based on other criteria. This result not only proves the effectiveness of bosutinib in patients with CML at different stages, but also provides new hope for those patients who have responded poorly to existing treatment options.

Further studies following patients treated with bosutinib showed that the drug's long-term effects remained significant during at least10 years of follow-up. These data demonstrate that bosutinib is able to stably provide antileukemic effects despite varying patient initiation settings, underscoring its important role in the treatment of chronic myelogenous leukemia.

Another study involving163 patients with chronic or advanced Ph+ CML further supported the effectiveness of bosutinib. The subjects of this study were all patients who had previously failed to treat at least one TKI or were unable to tolerate these drugs. The results showed that among 156 patients with chronic Ph+ CML, 72% had a major cytogenetic response, and among 7 patients with advanced disease, 75% achieved a hematological response after one year of treatment. This result once again confirms the superiority of bosutinib in the treatment of complex cases.

In addition, bosutinib was compared with conventional imatinib. in pairIn a study of 536 newly diagnosed CML patients, bosutinib was observed to be significantly more effective than imatinib. The incidence of major molecular response (MMR) was 47% in patients treated with bosutinib and only 37% in patients treated with imatinib. This difference further reinforces the advantage of bosutinib in treatment-naïve patients, suggesting that it may be more effective in controlling disease progression.

Reference materials:https://www.ema.europa.eu/en/medicines/human/EPAR/bosulif