![]() In patients with imatinib-resistant or imatinib-intolerant Ph+ CML, and in patients who had received prior imatinib plus dasatinib and/or nilotinib, bosutinib 500 mg once daily (QD) demonstrated durable efficacy and manageable toxicity after longer follow-up. Īpproval of bosutinib for patients with Ph+ CP, accelerated phase (AP), or blast phase (BP) CML previously treated with ≥1 TKI was based on results from a phase 1/2 study. TKIs radotinib and asciminib are emerging as treatment options. Therapy options in the second-line setting are dasatinib, nilotinib, and bosutinib, or the 3rd-generation BCR-ABL1 TKI ponatinib. However, patients may become resistant or intolerant to first-line TKI treatment. The 2nd-generation TKIs dasatinib, nilotinib, and bosutinib can be used as first-line therapy alternatives to imatinib for chronic phase (CP) CML. Imatinib was the first BCR-ABL1-targeting tyrosine kinase inhibitor (TKI) approved for the treatment of CML. The majority of patients had confirmed MCyR by 1 year and MMR by 1 year, further supporting bosutinib use for Ph+ CP CML patients resistant/intolerant to prior TKIs.Ĭhronic myeloid leukemia (CML) is a myeloproliferative neoplasm characterized by the presence of the Philadelphia chromosome (Ph). ![]() Across all patients, the most common treatment-emergent adverse events were diarrhea (87.7%), nausea (39.9%), and vomiting (32.5%). No patient progressed to AP/BP on treatment. Cumulative complete cytogenetic response (CCyR) and major molecular response (MMR) rates by 1 year were 80.6% and 70.5%, respectively, in Ph+ CP CML patients overall. Primary endpoint of cumulative confirmed major cytogenetic response (MCyR) rate by 1 year was 75.8% in Ph+ CP CML patients after one or two prior TKIs and 62.2% after three prior TKIs. As of ≥1 year after last enrolled patient (median treatment duration 23.7 months), 56.4% of Ph+ CP CML patients remained on bosutinib. In the ongoing phase 4 BYOND study (NCT02228382), 163 CML patients resistant/intolerant to prior TKIs ( n = 156 Ph+ CP CML, n = 4 Ph+ AP CML, n = 3 Ph-negative/ BCR-ABL1+ CML) received bosutinib 500 mg once daily (starting dose). Bosutinib is approved for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML) and for Ph+ CP, accelerated (AP), or blast (BP) phase CML after prior treatment with tyrosine kinase inhibitors (TKIs).
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