Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Margetuximab · 3 trials · 4 indications
PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first.
Overall survival is the time from randomization until death from any cause
Incidence of Grade 3 or higher infusion-related reactions for patients receiving 60-minute or 30-minute infusions of margetuximab in Cycle 2 of treatment
Response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria based on Cycle 2, Day 21 computed tomography (CT) scans. Response is categorized as complete response (CR): disappearance of all target lesions, confirmed at ≥ 4 weeks; partial response (PR): ≥ 30% decrease in target lesions from baseline, confirmed at ≥ 4 weeks; progressive disease (PD): ≥ 20% increase over smallest sum observed with an absolute increase of at least 5 mm, or appearance of new lesions; and stable disease (SD): neither PR or PD criteria met. A Simon two-stage design was planned in which an initial cohort of 21 patients was treated. If 2 or more responses (PR or CR) are seen at the first tumor re-evaluation on day 21 of Cycle 2, the study would be expanded to include up to 41 patients (20 additional patients in Cohort 2, the second stage of the study) in order to determine whether further development of the drug is warranted (5 or more responses in 41 evaluable patients).
Note that serious adverse events that are considered study drug related can be reported at any time after Study Day 50 or 28 days after the last infusion.
| Arm | Type | Description |
|---|---|---|
| Margetuximab plus chemotherapy | EXPERIMENTAL | Margetuximab 15 mg/kg every 21 days |
| Trastuzumab plus chemotherapy | ACTIVE_COMPARATOR | Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 21 days |
| Margetuximab Infusion Sub-study | EXPERIMENTAL | Margetuximab 15 mg/kg every 21 days (with or without chemotherapy), studying a shorter duration of infusion beginning in Cycle 2. |
| margetuximab | EXPERIMENTAL | Monotherapy of Anti-HER2 monoclonal antibody |
| Cohort 1: 0.1 mg/kg weekly for 4 weeks | EXPERIMENTAL | Anti-HER2 monoclonal antibody (margetuximab) |
| Cohort 2: 0.3 mg/kg weekly for 4 weeks | EXPERIMENTAL | Anti-HER2 monoclonal antibody (margetuximab) |
| Cohort 3: 1.0 mg/kg weekly for 4 weeks | EXPERIMENTAL | Anti-HER2 monoclonal antibody (margetuximab) |
| Cohort 4: 3.0 mg/kg weekly for 4 weeks | EXPERIMENTAL | Anti-HER2 monoclonal antibody (margetuximab) |
| Cohort 5: 6.0 mg/kg weekly for 4 weeks | EXPERIMENTAL | Anti-HER2 monoclonal antibody (margetuximab) |
| Cohort 6: 10 mg/kg weekly every 3 weeks | EXPERIMENTAL | Anti-HER2 monoclonal antibody (margetuximab) |
| Cohort 7: 15 mg/kg weekly every 3 weeks | EXPERIMENTAL | Anti-HER2 monoclonal antibody (margetuximab) |
| Cohort 8: 18 mg/kg weekly every 3 weeks | EXPERIMENTAL | Anti-HER2 monoclonal antibody (margetuximab) |
| Name | Type | Description |
|---|---|---|
| Margetuximab | BIOLOGICAL | 15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle, |
| Trastuzumab | BIOLOGICAL | 8 mg/kg via IV (intravenous) infusion for the first dose and 6 mg/kg for all subsequent doses via IV infusion on day 1 of each 21 day cycle |
| Physician's choice of chemotherapy. | DRUG | Capecitabine (Xeloda®):1000 mg/m2 BID for 14 days in a 21-day cycle, or Eribulin (Halaven®): 1.4 mg/m2 on days 1 and 8 of a 21-day cycle, or Gemcitabine (Gemzar®): 1000 mg/m2 on days 1 and 8 of a 21-day cycle, or Vinorelbine (Navelbine®): 25-30 mg/m2 on days 1 and 8 of a 21-day cycle |
Inclusion Criteria: * Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative. * Have received at ...
Margetuximab is an investigational monoclonal antibody being developed for the treatment of HER2-positive breast cancer and gastric cancer. It is designed to target HER2-expressing tumors and is being studied in metastatic breast cancer and advanced gastric or gastroesophageal junction cancer.
Margetuximab targets the HER2 receptor, a protein that can promote cancer cell growth. As a monoclonal antibody, it binds to HER2 on tumor cells, potentially interfering with cancer growth signals. It is being evaluated in HER2-positive breast cancer and gastric cancer.
Margetuximab is being developed by MacroGenics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker MGNX. The company has conducted clinical trials of Margetuximab in HER2-positive breast cancer and gastric cancer.
Margetuximab has completed Phase 3 clinical development for HER2-positive metastatic breast cancer. The Phase 3 trial, NCT02492711, compared Margetuximab plus chemotherapy to trastuzumab plus chemotherapy. Margetuximab remains investigational and is not yet FDA approved.
Margetuximab has been studied in several completed trials, including NCT02492711, a Phase 3 trial in HER2-positive metastatic breast cancer with 624 participants, and NCT02689284, a Phase 1 trial combining Margetuximab with pembrolizumab in gastric cancer. Other trials include NCT01148849 and NCT01828021.
Yes, Margetuximab was formerly known as MGAH22 in earlier clinical trials. The Phase 1 study NCT01148849 and Phase 2 study NCT01828021 both used the name MGAH22 to refer to the same investigational monoclonal antibody.