InnoCare, a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today the company presented the latest clinical data of the Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib at the 16th International Conference on Malignant Lymphoma (ICML). Orelabrutinib showed a significant higher rate of complete response (CR) with the extended time of treatment.

Updated Efficacy and Safety Results of Orelabrutinib in the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Cell lymphoma.

Abstract Number: 131

Orelabrutinib is a novel and highly selective irreversible BTK inhibitor. According to the previous reported data, orelabrutinib had high bioavailability with near 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. The median follow-up time was 25.6 months.

The efficacy results were evaluated by both IRC and investigators, with the ORR of 93.8% with 21.3% CR/CRi, 61.3% PR, and 11.3% PR-L by investigators, and the ORR of 92.5% with 16.3% CR/CRi, 65.0% PR and 11.3% PR-L by IRC. 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. 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 concerns. Similar to the previous reported safety results, most AEs were mild to moderate.

Professor Wei Xu, deputy director of the Department of Hematology, Jiangsu Provincial People's Hospital, said, "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."

The ICML is held online from June 18 to 22, 2021, which is organized every two years. The ICML meeting represented a high level of lymphoma research and treatment, which not only gathered international experts in the field of lymphoma, but also demonstrated the trend of malignant lymphoma treatment.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Guangzhou, Shanghai, New Jersey, and Boston.