Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zanidatamab · 7 trials · 23 indications
PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by BICR according to RECIST v1.1) or death from any cause, whichever occurs first.
PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.
The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1) as assessed by blinded independent central review (BICR) or death from any cause
The time from randomization to death due to any cause
Confirmed Objective Response Rate (ORR) for each cohort, based on best overall response, defined as the percentage of patients with a complete response (CR) or partial response (PR) during treatment or follow-up, assessed according to RECIST1.1, by investigator assessment and confirmed by a follow-up scan at ≥ 4 weeks from first response assessment.
Pathologic complete response (pCR) is defined as lacking all signs of cancer in the tissue samples removed in the breast or axilla (armpit) during surgery or biopsy after study treatment
The Independent Central Review (ICR) assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Number of patients who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to zanidatamab or evorpacept (ALX148), including combination of zanidatamab with evorpacept (ALX148)
Number of patients who experienced AEs, serious adverse events (SAEs), or adverse events of special interest (AESIs)
Number of patients who experienced a Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0
Number of patients who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
| Arm | Type | Description |
|---|---|---|
| Zanidatamab plus physician's choice of chemotherapy | EXPERIMENTAL | Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of zanidatamab plus physician's choice of chemotherapy (eribulin, or vinorelbine, or gemcitabine, or capecitabine). |
| Trastuzumab plus physician's choice of chemotherapy | ACTIVE_COMPARATOR | Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of trastuzumab plus physician's choice of chemotherapy (eribulin, or gemcitabine, or vinorelbine, or capecitabine). |
| Zanidatamab with Standard-of-care Therapy Arm | EXPERIMENTAL | Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. |
| Standard-of-care Therapy Arm | ACTIVE_COMPARATOR | Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. |
| Arm A | ACTIVE_COMPARATOR | Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP) |
| Arm B | EXPERIMENTAL | Zanidatamab plus physician's choice of CAPOX or FP |
| Arm C | EXPERIMENTAL | Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP |
| zanidatamab | EXPERIMENTAL | Single arm study where the experimental regimen used for all patients will be zanidatamab, administered intravenously every 3 weeks : * Patients \<70 kg: 1800 mg IV Q3W on Day 1 of each 21-day cycle * Patients ≥70 kg: 2400 mg IV Q3W on Day 1 of each 21-day cycle. |
| Zanidatamab with paclitaxel | ACTIVE_COMPARATOR | Zanidatamab in combination with chemotherapy paclitaxel |
| Zanidatamab with docetaxel and carboplatin | ACTIVE_COMPARATOR | Zanidatamab in combination with chemotherapy docetaxel and carboplatin |
| Trastuzumab and pertuzumab with docetaxel and carboplatin | ACTIVE_COMPARATOR | Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin |
| Zanidatamab treatment arm | EXPERIMENTAL | Eligible participants receiving zanidatamab treatment |
| Zanidatamab plus evorpacept (ALX148) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Zanidatamab | DRUG | Administered by intravenous infusion |
| Trastuzumab | DRUG | Administered by intravenous infusion |
| Eribulin | DRUG | Administered by intravenous infusion |
| Vinorelbine | DRUG | Administered by intravenous infusion |
| Gemcitabine | DRUG | Administered by intravenous infusion |
| Capecitabine | DRUG | Given orally |
| Cisplatin | DRUG | Administered intravenously (IV) |
| Pembrolizumab | DRUG | Administered intravenously (IV) |
| Durvalumab | DRUG | Administered intravenously (IV) |
| Tislelizumab | DRUG | Administered IV |
| Oxaliplatin | DRUG | Administered IV |
| 5-Fluorouracil | DRUG | Administered IV |
| Paclitaxel | DRUG | Administered intravenously (IV) |
| Docetaxel | DRUG | Administered intravenously (IV) |
| Carboplatin | DRUG | Administered intravenously (IV) |
| Pertuzumab | DRUG | Administered intravenously (IV) |
| Evorpacept | DRUG | Administered IV |
Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent. 2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidel...
Zanidatamab is an investigational oncology therapy being studied for HER2-expressing cancers, including gastric neoplasms, HER2-positive breast cancer, metastatic HER2-positive breast cancer, and non-small cell lung cancer. It is currently in Phase 3 clinical development and has not been approved by the FDA.
Zanidatamab targets ERBB2, also known as HER2, and acts as an inhibitor of this receptor. By inhibiting ERBB2, the drug is designed to interfere with signaling pathways that drive tumor growth in HER2-expressing cancers.
Zanidatamab is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple HER2-positive cancer indications.
Zanidatamab is in Phase 3 clinical development for gastric and esophageal cancers and metastatic HER2-positive breast cancer. It has received FDA designations including Breakthrough Therapy, Fast Track, Orphan Drug, and Priority Review, but it remains investigational and is not yet FDA approved.
Zanidatamab is being studied in several trials, including NCT05152147, a Phase 3 study in HER2-positive gastric and esophageal cancers; NCT06435429, a Phase 3 study in metastatic HER2-positive breast cancer; and NCT06695845, a Phase 2 study in HER2-expressing tumors. These trials are actively recruiting or ongoing.
Zanidatamab is a distinct investigational agent that targets ERBB2 (HER2) and is being compared against trastuzumab in a Phase 3 breast cancer trial. No alternative names for Zanidatamab have been disclosed, and it is not the same as other approved HER2 inhibitors.