New BTK inhibitors bring dawn to the treatment of hematological tumors

Source: Medical Network

Recently, the reporter learned from the 62nd Annual Meeting of the American Society of Hematology (ASH) that Bruton's tyrosine kinase (BTK) inhibitor abutinib is used in the treatment of relapsed/refractory mantle cell lymphoma (MCL) and relapsed Two clinical studies of refractory chronic lymphocytic leukemia (CLL)/small cell leukemia (SLL) have shown good overall remission rate and safety.

In a study of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL), a total of 80 patients were enrolled in the clinical trial, and most of the patients were in the advanced stage of the disease. The follow-up time was 14.3 months. The independent review committee (IRC) assessed that the overall response rate (ORR) was 91.3%, of which the complete response rate (CR) was 10.0%, the partial response rate was 63.8%, and the partial response rate with lymphocytosis was 17.5%.

"It can be said that abutinib has a high complete remission rate, a lasting remission rate and safety improvement in the treatment of R/R CLL/SLL patients. As a highly selective with good pharmacokinetic and pharmacodynamic properties The BTK inhibitor, obritinib provides patients with better treatment options, and is expected to become an excellent choice for combination therapy." Professor Xu Wei, deputy director of the Department of Hematology, Jiangsu Provincial People’s Hospital, said that most adverse events were mild to mild to Moderate, time-extended follow-up analysis found no new safety issues.

Another multicenter, open, phase II clinical study is the long-term safety and effectiveness of abutinib monotherapy in Chinese patients with relapsed/refractory mantle cell lymphoma (R/R MCL). A total of 106 patients were enrolled in the study, with a median follow-up time of 16.4 months, and most patients were in the advanced stage of the disease. According to the Lugano standard (2014) evaluation, the overall remission rate was 87.9%, and 93.9% of patients achieved disease control.

"The study found that obatinib showed sustained efficacy in the treatment of R/R MCL patients, and there was no treatment-related atrial fibrillation/atrial flutter, bleeding or diarrhea of grade 3 or above, which supports obritinib Become a better choice for BTK inhibitor therapy." Song Yuqin, deputy director of the Department of Lymphatic Oncology, Peking University Cancer Hospital, said that adverse events mainly include thrombocytopenia, neutropenia, leukopenia and hypertension.

In addition, the reporter also learned that there are 5 ongoing studies of abutinib, covering a total of 266 patients. The preliminary safety results show that compared with other BTK inhibitors, there are adverse events related to BTK off-target for abutinib. (Such as atrial fibrillation/atrial flutter, diarrhea, etc.) are less likely.

It is reported that Obutinib is a Class 1 innovative drug independently developed by Nuocheng Jianhua. It is mainly used for the treatment of lymphoma and autoimmune diseases, and is supported by the national major new drug creation project.