PFS was evaluated by blinded independent central review (BICR).
Explore prespecified exploratory subgroups by Fc𝛄 receptor genotype
See Exploratory PFS Analysis by CD16A Genotype
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.2
Explore prespecified exploratory subgroups by Fc𝛄 receptor genotype
See Exploratory OS Analysis by CD16A Genotype
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.
See dosage and administration information
Learn more about the
SOPHIA study
Safety of MARGENZA in combination with chemotherapy1
Adverse Reaction | MARGENZA + chemotherapy (n=264) | Trastuzumab + chemotherapy (n=266) | ||
---|---|---|---|---|
All grades (%) | Grade 3 or 4 (%) | All grades (%) | Grade 3 or 4 (%) | |
Fatigue/Asthenia | 57 | 7 | 47 | 4.5 |
Nausea | 33 | 1.1 | 32 | 0.4 |
Diarrhea | 25 | 2.3 | 25 | 2.3 |
Vomiting | 21 | 0.8 | 14 | 1.5 |
Constipation | 19 | 0.8 | 17 | 0.8 |
Headachea | 19 | 0 | 16 | 0 |
Pyrexia | 19 | 0.4 | 14 | 0.4 |
Alopecia | 18 | 0 | 15 | 0 |
Abdominal painb | 17 | 1.5 | 21 | 1.5 |
Peripheral neuropathyc | 16 | 1.1 | 15 | 2.3 |
Arthralgia/Myalgia | 14 | 0.4 | 12 | 0.8 |
Cough | 14 | 0.4 | 12 | 0 |
Decreased appetite | 14 | 0.4 | 14 | 0.4 |
Dyspnea | 13 | 1.1 | 11 | 2.3 |
Infusion-related reaction | 13 | 1.5 | 3 | 0 |
Palmar-plantar erythrodysesthesia | 13 | 0 | 15 | 3 |
Extremity pain | 11 | 0.8 | 9 | 0 |
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. Rugo HS, Im S, Cardoso F, et al. Phase 3 SOPHIA study of margetuximab + chemotherapy versus trastuzumab + chemotherapy in patients with HER2+ metastatic breast cancer after prior anti-HER2 therapies: Final overall survival analysis. Presented at San Antonio Breast Cancer Symposium on December 9, 2021 (#2484).
Dosage and administration
information
CD16A-158F (FF or FV), n=437 (86%)
CD16A-158FF, n=192 (38%)
CD16A-158FV, n=245 (48%)
CD16A-158VV, n=69 (14%)
Limitation: These are exploratory analyses; therefore, the data require cautious interpretation and could represent chance findings.
a506 of 536 intention-to-treat patients were genotyped (94%)
CI=confidence interval; HR=hazard ratio
1. Rugo HS, Im S, Cardoso F, et al. Efficacy of margetuximab vs trastuzumab in patients with pretreated ERBB2-positive advanced breast cancer: a phase 3 randomized clinical trial – Supplemental online content. JAMA Oncol. Published online January 22, 2021. doi: 10.1001/jamaoncol.2020.7932
CD16A-158F (FF or FV), n=437 (86%)
CD16A-158FF, n=192 (38%)
CD16A-158FV, n=245 (48%)
CD16A-158VV, n=69 (14%)
Limitation: These are exploratory analyses; therefore, the data require cautious interpretation and could represent chance findings.
a506 of 536 intention-to-treat patients were genotyped (94%)
CI=confidence interval; HR=hazard ratio
1. Rugo HS, Im S, Cardoso F, et al. Phase 3 SOPHIA study of margetuximab + chemotherapy versus trastuzumab + chemotherapy in patients with HER2+ metastatic breast cancer after prior anti-HER2 therapies: Final overall survival analysis. Presented at San Antonio Breast Cancer Symposium on December 9, 2021 (#2484).
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%).
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).
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.
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%).
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).
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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