InnoCare Pharma (HKEX: 09969), a leading biotech company, announced today that leading PIs presented latest data of BTK inhibitor orelabrutinib at the 63rd American Society of Hematology (ASH) Annual Meeting on December 11-14, 2021, which is hold online and offline in Atlanta, Georgia.
The study in patients with relapsed or refractory (r/r) Waldenstrom's Macroglobulinemia, led by Professor Daobin Zhou, is selected as oral presentation, and the study in patients with r/r Chronic Lymphocytic Leukemia/Small Cell Leukemia, led by Professor Jianyong Li, and the study with orelabrutinib in the treatment of Primary Immune Thrombocytopenia, led by Professor Ming Hou, are selected as posters.
Oral Presentation:
Efficacy and Safety of Orelabrutinib in Relapsed/Refractory Waldenstrom's Macroglobulinemia Patients
Abstract Number: 46
This study is aimed to evaluate the efficacy and safety of orelabrutinib for the treatment of R/R WM patients. The primary endpoint was major response rate (MRR) as assessed by IRC. Key secondary endpoints were MRR as assessed by investigator, overall response rate (ORR), duration of major response (DOMR), progression-free survival (PFS), OS, etc.
With a median duration of treatment of 13.67 months, MRR was 78.7% as assessed by investigator. ORR was 87.2%. The estimated 12-month DOMR was 91.3%. The estimated 12-month PFS and OS were 89.3% and 93.6%, respectively. The median PFS and median OS have not been reached.
The most commonly reported adverse events (AE) were thrombocytopenia, neutropenia, leukopenia, upper respiratory infection. There was no reported grade ≥3 atrial fibrillation and/or atrial flutter, or grade ≥3 diarrhea.
Professor Daobin Zhou commented that "Orelabrutinib has demonstrated substantial efficacy in treating r/r WM patients under short-term follow-up period. It has shown favorable safety and tolerability profile. It has the potential to be a promising treatment option for r/r WM patients."
Poster Presentation 1:
Orelabrutinib Monotherapy in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Updated Long Term Results of Phase II Study
Abstract Number: 2638
A total of 80 patients with R/R CLL/SLL were enrolled. The median follow-up time was 33.1 months, with 67.5% remaining on study treatment.
The overall response rate (ORR) was 93.8 % with 26.3% CR/CRi as assessed by investigator. Median time for achieving first response was 1.84 months. The median duration of response (DOR) and progression-free survival (PFS) were not reached. The estimated 30-month DOR and PFS were 67.2% and 69.7% respectively by investigator assessed.
Orelabrutinib showed a significant higher CR/CRi rate in R/R CLL/SLL in comparison with other BTK inhibitors at a similar median follow-up period.
Extended follow-up demonstrated that there were no emerging safety concerns. Similar to the previous reported safety results, most AEs were mild to moderate.
Professor Wei Xu commented that "This updated study result further confirms that orelabrutinib is efficacious in treating R/R CLL patients with significant higher CR rate than other BTK inhibitors, durable response and improved safety profiles. Orelabrutinib provides a favorable therapeutic choice for patients with R/R CLL/SLL and has great potential to be the best candidate for the combination therapy."
Poster Presentation 2:
Orelabrutinib, a Selective Bruton's Tyrosine Kinase (BTK) Inhibitor in the Treatment of Primary Immune Thrombocytopenia (ITP)
Abstract Number: 3172
Primary immune thrombocytopenia (ITP) is the most common autoimmune hemorrhagic disorder characterized by decreased platelet count, increased risk of bleeding, and poor quality of life. Only about 70% patients response to first-line treatments, some patients are still refractory or relapsed after combined therapies, therefore it is necessary to explore new therapeutic targets. Bruton's tyrosine kinase (BTK) is a non-receptor tyrosine kinase of Tec family, which is widely expressed in hematopoietic cells including B cells, monocytes/macrophages, and others. Inhibition of BTK ...
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