Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ascentage Pharma HQP1351 bioavailable inhibitor
Olverembatinib · 4 trials · 10 indications
Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.
To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib
To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation
The minimal residual disease negative CR rate of olverembatinib combined with chemotherapy versus investigator's choice of TKI combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
To evaluate the Maximum Plasma Concentration (Cmax) of HQP1351
To evaluate the Area Under the Curve (AUC) of HQP1351
| Arm | Type | Description |
|---|---|---|
| Olverembatinib | EXPERIMENTAL | - |
| Part A, RCT, olverembatinib arm and bosutinib arm | OTHER | Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs |
| Part B, SAT, olverembatinib arm | OTHER | To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously |
| Investigator's choice of TKI | ACTIVE_COMPARATOR | Investigator's choice of TKI in combination with chemotherapy |
| Cohort A | EXPERIMENTAL | - |
| Cohort B | EXPERIMENTAL | - |
| Cohort C | EXPERIMENTAL | - |
| Cohort D | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Olverembatinib | DRUG | Oral administration with meal, QOD, every 28 days for a cycle. |
| Bosutinib | DRUG | Bosutnib QD |
| Investigator's choice of TKI | DRUG | Oral (PO) once daily (QD). |
| Ascentage Pharma HQP1351 bioavailable inhibitor | DRUG | HQP1351 taken by mouth every other day |
| Blinatumomab | DRUG | Administered in all patients as a continuous IV infusion at the dosage of 28μg daily (9μg daily for Cycle 1 Day 1 to Day 7). |
Inclusion Criteria: 1. Histologically and/or cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator. 2. Must have at least one measurable target ...
Olverembatinib is an investigational small molecule being studied in chronic myeloid leukemia (CML), Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and SDH-deficient gastrointestinal stromal tumor (GIST). It is in Phase 3 clinical development and is not yet approved. Trials are enrolling adults and, in the GIST study, patients as young as 12 years.
Olverembatinib is an inhibitor that targets ABL1 and BCR. By inhibiting these targets, it is designed to interfere with the signaling that drives certain leukemias and solid tumors. Its clinical program includes biomarker-selected patient populations, and the trials are controlled and randomized.
Olverembatinib is being developed by Ascentage Pharma Group International, which trades under the ticker AAPG as American Depositary Shares. The company is running the clinical program across multiple countries, including the United States, China, and several European and Asian nations.
Olverembatinib is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The program includes Phase 3 studies in CML in chronic phase, newly diagnosed Ph+ ALL, and SDH-deficient GIST, plus an earlier Phase 1 study in refractory CML and Ph+ ALL.
Olverembatinib is being studied in several trials, including NCT06423911 in CML chronic phase, NCT06051409 (POLARIS-1) in newly diagnosed Ph+ ALL, NCT06640361 in SDH-deficient GIST, and NCT04260022 in refractory CML and Ph+ ALL. All are currently recruiting, with total planned enrollment across the program of about 575 patients.
Yes. Olverembatinib is also known as HQP1351, and it has been referred to as a bioavailable inhibitor and in a 20mg dose form. The Phase 3 CML study and the Phase 1 refractory leukemia study both use the HQP1351 name, so search results for either name refer to the same investigational drug.