Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HBI-8000 · 2 trials · 2 indications
Tumor assessment was performed every 8 weeks until disease progression. Objective response rate was defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR) according to International Workshop Response Criteria (IWC) 2014 criteria and assessed by an Independent Overall Efficacy Review Committee (IOERC). CR: Target nodes/nodal masses must regress to \<1.5 cm in longest transverse diameter of a lesion (LDi), no extralymphatic sites of disease, nonmeasured lesion is absent, disappearance of spleen or liver enlargement, no new lesions, no bone marrow (BM) involvement. PR: ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites, nonmeasured lesions is absent/normal, regressed, but no increase, spleen must have regressed by \>50% in length beyond normal, no new lesions.
| Arm | Type | Description |
|---|---|---|
| HBI-8000 | EXPERIMENTAL | Four 10 mg tablets or less twice weekly orally approximately 30 minutes after any regular meal. The treatment will be continuous, with 3-4 days between dosing. Treatment will continue until disease progression in the absence of unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| HBI-8000 | DRUG | Orally twice weekly |
Inclusion Criteria: 1. Histological or cytological diagnosis of the following peripheral T-cell lymphoma (PTCL) subtypes as defined by the WHO classification (2008) may be included: 1. PTCL, NOS 2. Angioimmunoblastic T-cell lymphoma (AITL) 3. Anaplastic large-cell lymphoma (ALCL), ALK+ ...
HBI-8000 is an investigational small molecule being studied for the treatment of adult T-cell lymphoma (ATL) and peripheral T-cell lymphoma (PTCL). It is administered orally and is currently in Phase 2 clinical development for these oncology indications.
HBI-8000 is being developed by IQVIA Holdings, Inc., a company traded on the New York Stock Exchange under the ticker symbol IQV. The drug is an oral small molecule in Phase 2 clinical trials for the treatment of lymphomas.
HBI-8000 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for the treatment of adult T-cell lymphoma and peripheral T-cell lymphoma.
HBI-8000 has been studied in two completed Phase 2 clinical trials. One trial, NCT02953652, evaluated the drug in 55 patients with relapsed or refractory peripheral T-cell lymphoma in Japan and South Korea. Another trial, NCT02955589, studied it in 23 patients with adult T-cell lymphoma in Japan.
No alternative names for HBI-8000 have been disclosed. The drug is identified by its code name HBI-8000 in clinical trials and is being developed as a standalone investigational agent for the treatment of certain types of lymphoma.