PFS was evaluated by blinded independent central review (BICR).
ORR and DOR were evaluated by BICR.
The final OS analysis of the SOPHIA study was performed after 385 OS events occurred in the intent-to-treat (ITT) population. The final OS analysis for the ITT population did not demonstrate a statistically significant advantage for MARGENZA plus chemotherapy compared to trastuzumab plus chemotherapy (HR=0.95; 95% CI: 0.77-1.17; P=0.62).2
The efficacy and safety of MARGENZA plus chemotherapy compared to trastuzumab plus chemotherapy was evaluated in SOPHIA, a randomized, multicenter, open-label trial of 536 metastatic HER2-positive breast cancer patients* who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
*IHC 3+ or ISH-amplified HER2+.
aThe median number of prior lines of therapy in the locally advanced/metastatic setting was 2 (range: 1-4). All study patients had previously received trastuzumab, all but 1 patient had previously received pertuzumab, and 91% had previously received ado-trastuzumab emtansine; 47% had visceral disease, 57% had bone metastases, 13% had brain metastases, and 60% were hormone receptor positive.
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Safety of MARGENZA in combination with chemotherapy1
aIncludes headache and migraine.
bIncludes abdominal pain, abdominal discomfort, lower abdominal pain, and upper abdominal pain.
cIncludes peripheral neuropathy, peripheral sensory neuropathy, peripheral motor neuropathy, and neuropathy.
Serious adverse reactions occurred in 16% of patients who received MARGENZA.
Permanent discontinuation due to an adverse reaction occurred in 3% of patients who received MARGENZA.
1. MARGENZA Prescribing Information. MacroGenics, Inc.; 2020.
2. Data on File. MacroGenics, Inc.; 2021.
Dosage and administration
WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY
The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia (57%), nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%), headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%), peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%), decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%), palmar-plantar erythrodysesthesia (13%), and extremity pain (11%).
MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
Please see full Prescribing Information, including Boxed Warning.
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