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Article source: Medical Rubik's Cube Info
Author: Shi Bei
At present, a variety of BTK small molecule inhibitors have been successfully applied to the treatment of B-cell lymphoma in clinical practice.
On December 12th, Loxo and Merck, a subsidiary of Eli Lilly, announced their oral, highly selective, non-covalent (reversible) BTK C481S inhibitors pirtobrutinib and MK-1026 at the 63rd Annual Meeting of the American Society of Hematology (ASH).
Phase I/II study of Pirtobrutinib in the treatment of CLL/SLL and MCL
Phase I/II study of Pirtobrutinib in the treatment of CLL/SLL and MCLAt the conference, Loxo announced the updated data of the global phase I/II BRUIN clinical trial of pirtobrutinib in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL)
BRUIN is the largest clinical trial conducted so far.
Among the 252 patients with CLL/SLL who had previously received BTKi treatment and whose curative effect was assessable, 171 had a response, including 2 CR, 137 PR, 32 partial remission with persistent lymphocytosis (PR-1), 62 SD, ORR 68%
Patients who received at least one BTKi treatment (median treatment line: 3) have not yet reached the median PFS, and patients who have received at least one BTKi and BCL2 inhibitor (median treatment line: 5 lines) have an estimated median PFS of 18 Month
Among 100 patients with MCL who have received BTKi treatment and whose efficacy can be evaluated, 51 have responded, including 25 CRs and 26 PRs, with an ORR of 51% (95% CI: 41-61)
Among all 618 patients participating in the study, the most common adverse events (regardless of attribution) included fatigue (23%), diarrhea (19%), neutropenia (18%), and contusion (17%)
Phase II study of MK-1026 in the treatment of CLL/SLL
Phase II study of MK-1026 in the treatment of CLL/SLLMerck announced the Phase II dose extension study data of MK-1026 in CLL/SLL patients
A total of 51 CLL/SLL patients received the MK-1026 phase II recommended dose (65 mg, once a day) treatment, 43 (84%) patients had previously received BTKi treatment, and 32 patients (63%) had C481S BTK mutations
In terms of safety, among all treated patients, the incidence of treatment-related TEAEs was 66%, 26.
