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• W3175573707 abstract "Introduction: Orelabrutinib is a novel and highly selective irreversible BTK inhibitor. We previously reported that orelabrutinib had high bioavailability with ∼100% BTK occupancy at 24 hours at 150 mg daily dosing regimen and had demonstrated excellent safety and efficacy profiles in a phase II trial of r/r CLL/SLL. Here we present an updated result following the extended time of treatment. Method: This is an open-label, multicenter, phase II study to evaluate the safety and efficacy following an oral daily administration of orelabrutinib. Responses were assessed per 2008 IWCLL criteria. Results: A total of 80 patients with r/r CLL/SLL were enrolled. Eligible patients received ≥1 prior treatment with median age of 60.0 years. There are 70% of patients for Rai stage 3-4 disease, 22.5% for del(17p) and/or TP53 mutation, 41.3% for unmutated IGHV and 23.8% for del(11q). The median follow-up time was 25.6 months, with 71.3% remaining on study treatment. The efficacy results were evaluated by both IRC and investigators, with the ORR of 92.5 % with 16.3% CR/CRi, 65.0% PR and 11.3% PR-L by IRC, and the ORR of 93.8% with 21.3% CR/CRi, 61.3% PR, and 11.3% PR-L by investigators. These results revealed high concordance rate for overall response assessments between IRC and investigator. Median time for achieving first response was 1.87 months. The median DOR and PFS were not reached. The estimated 18-month DOR was 77.2%, and PFS was 78.7% by IRC. The ORR was 100% in patients with Del(17p) and/or TP53 mutation. The ORR was 94.7% for Del(11q)) and 93.9% for unmutated IGHV. Comparing to the previous CR/CRi rate of 8.8% and 10.0% reported at median follow up of 14.3 months, the updated CR/CRi rate had achieved 21.3% and 16.3% by investigator and IRC assessment, respectively. Orelabrutinib showed a significant higher CR/CRi rate in r/r CLL/SLL comparing to other BTK inhibitors at a similar median follow-up period. Extended follow-up analysis did not reveal new safety nor toxicity concerns. Similar to the previous reported safety results, most AEs were mild to moderate. The most frequent AEs were hematological toxicities, upper respiratory tract infection, pneumonia and hypokalemia. No case of atrial fibrillation nor secondary malignancy was reported, no patient was observed for ≥3 grade hypertension and only one patient had ≥3 grade diarrhea. Major hemorrhage was reported in 2 patients, one with intracranial hemorrhage (65-year old patient with >10 years hypertension) and the other with vitreous hemorrhage which was assessed as unlikely related to the treatment of orelabrutinib. Conclusion: This updated study result further confirms that orelabrutinib is efficacious in treating r/r CLL patients with a significant higher CR rate, durable response and improved safety profiles. Orelabrutinib provides a favorable therapeutic choice for patients with r/r CLL/SLL and a potential best candidate for the combination therapy. EA – previously submitted to regional or national meetings (up to 1000 attendees) The research was funded by: Beijing InnoCare Pharma Tech Co., Ltd Keywords: Chronic Lymphocytic Leukemia (CLL) Conflicts of interests pertinent to the abstract R. Zhao Employment or leadership position: Employment B. Zhang Employment or leadership position: Employment" @default.
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• W3175573707 date "2021-06-01" @default.
• W3175573707 modified "2023-09-24" @default.
• W3175573707 title "UPDATED EFFICACY AND SAFETY RESULTS OF ORELABRUTINIB IN THE TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL CELL LEUKEMIA" @default.
• W3175573707 doi "https://doi.org/10.1002/hon.43_2880" @default.
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