Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-Poziotinib, HM781-36B
Poziotinib · 1 trial · 1 indication
ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) among participants in the Evaluable Population assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR was based on investigator assessed BOR. Per RECIST v1.1 for target lesions, CR was disappearance of all target tumor lesions (TLs) and all target lymph nodes (LNs) with short axis \<10mm. PR was ≥30% decrease in sum of diameters (SOD) from Baseline, and not progressive disease (PD) (≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm).
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Poziotinib 24 mg | EXPERIMENTAL | Participants received poziotinib 24 milligrams (mg), administered as three 8 mg tablets, orally, once daily (QD) on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable adverse events (AEs) or for up to a maximum of 24 months, whichever occurs first. |
| Cohort 2: Poziotinib 16 mg | EXPERIMENTAL | Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Poziotinib | DRUG | 8 mg oral tablets, administered QD. |
Inclusion Criteria: 1. Histopathologically confirmed primary breast cancer with metastatic lesions. 2. Confirmed HER2 overexpression or gene-amplified tumor 3. At least two prior HER2-directed therapy regimens for breast cancer, including trastuzumab and trastuzumab emtansine 4. Measurable disease ...
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Poziotinib is an investigational small molecule being studied for the treatment of breast cancer, specifically HER2-positive metastatic breast cancer. It is in Phase 2 clinical development and has been evaluated in a completed trial of 67 participants with this condition. It is not described as an approved therapy.
Poziotinib targets ERBB2 (HER2), EGFR, ERBB4, and ERBB3. It is classified as an inhibitor of these receptor tyrosine kinases. By inhibiting these targets, it is designed to interfere with signaling pathways that drive tumor growth in cancers such as HER2-positive breast cancer.
Poziotinib is being developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company is responsible for the clinical development of the drug in oncology, including the completed Phase 2 study in HER2-positive metastatic breast cancer.
Poziotinib is in Phase 2 clinical development. It has completed one Phase 2 trial in HER2-positive metastatic breast cancer. There are currently no active trials listed for this drug. It is an investigational agent and has not been approved by the FDA for any indication.
Poziotinib has been studied in a completed Phase 2 trial, NCT02659514, titled "Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer." The trial enrolled 67 participants in the United States and included adults 18 years and older of all sexes.
Yes, [14C]-Poziotinib is an alternative name for Poziotinib. The carbon-14 labeled form is used in research settings, but both refer to the same active drug substance. Poziotinib is the primary name used in clinical development by Assertio Holdings, Inc.