Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has presented the results of multiple clinical trials for two of its pipeline candidates at the 29th European Hematology Association (EHA) Annual Meeting. The candidates are olverembatinib, a Category 1 drug and approved BCR-ABL inhibitor, and the investigational BCL-2 inhibitor lisaftoclax (APG-2575).
- Olverembatinib is indicated for patients with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have previously received severe tyrosine kinase inhibitor (TKI) treatment. The trial showed that 60.8% of CML patients and 21.4% of Ph+ALL patients achieved complete cytogenetic response (CCyR), while 42.4% of CML patients and 17.6% of Ph+ALL patients achieved major molecular response (MMR). The drug demonstrated good safety, with mostly mild or moderate side effects.
- The combination of olverembatinib with chemotherapy or bispecific T cell engager (BITE) blinatumomab as a first-line treatment for Ph+ALL was studied in 31 newly diagnosed patients. After a median follow-up of 16 months, all patients achieved complete remission (CR) after one treatment cycle. In the combination chemotherapy cohort, 16 patients (84.2%) achieved complete molecular response (CMR) within three months, and in the combination BITE cohort, 12 patients (100.0%) achieved CMR. The safety of the combination therapy was found to be acceptable.
- The impact of olverembatinib treatment on health-related quality of life (HRQoL), anxiety, and depression symptoms in TKI-resistant CML patients was evaluated using the EORTC QLQ-C30 questionnaire. The three most severe symptom burdens at baseline were economic difficulties, fatigue, and insomnia. After achieving MMR, patients’ overall health, nausea, vomiting, and diarrhea significantly improved. At baseline, 16% of patients had mild or moderate anxiety symptoms, 32% had mild depression symptoms, and 12% had moderate or severe depression symptoms. The SAS score significantly decreased over time during treatment with olverembatinib. At 36 months of treatment, 95% and 59% of patients were identified as having no symptoms of anxiety or depression based on the SAS and SDS questionnaire evaluations, respectively.
- Lisaftoclax (APG-2575) was combined with a novel treatment regimen for recurrent/refractory (R/R) multiple myeloma (MM) or immunoglobulin light chain amyloidosis (AL) patients. The study treatment regimen included APG-2575 combined with pomalidomide and dexamethasone (groups A and C) or daratumumab, lenalidomide, and dexamethasone (group B). The overall response rate (ORR) of 27 evaluable R/RMM patients in Group A was 70.4%, with 2 cases achieving complete response (CR). Two R/R MM patients in Group B achieved CR. The ORR of 7 evaluable R/R AL patients in Group C was 85.7%, with 2 cases achieving CR. The overall tolerability of the APG-2575 combination therapy was good.- Flcube.com
