The FDA has approved Margenza plus chemo for adult patients with metastatic HER2+ breast cancer who have previously treated with two or more anti-HER2 regimens, and minimum one of which was used for the metastatic disease.
According to Dr. Koenig MD, PhD, president and Chief Executive Officer of MacroGenics, “With the margenza approval, MacroGenics can consider it a remarkable milestone, and more importantly, it provides an advanced treatment option in order to treat patients who are with metastatic breast cancer. We are very thankful for those candidates who have participated in this study, as well as their families, and every individual who has played a key role in order to help MacroGenics reach this remarkable milestone.”
“As we prepare for our 1’st commercial launch and positively look forward to being able to deliver margenza to patients, we want to continue to concentrate on developing as well as commercializing innovative antibody-based therapeutics for treating the cancer with eight product candidates currently in the clinical development,” he also added.
The phase 3 SOPHIA trial carried out, in which the agent plus chemo has shown a statistically significant reduction of around 24% in the risk of disease progression or death in comparison to the trastuzumab (Herceptin) plus chemo (HR, 0.76; 95% CI, 0.59-0.98; P =.033), with a median progression free survival of around 5.8 months versus 4.9 months, respectively. The observed objective response rate for margenza plus chemo was noted around 22% and for the trastuzumab plus chemo was around 16%. The final OS analysis is expected to come in the 2’nd half of 2021.
Side effects occurring in about more than 20% of patients who have received the margenza plus chemotherapy included vomiting (21%), diarrhea (25%), nausea (33%), and fatigue/asthenia (57%).
Notably, the US Prescribing information basically contains a Boxed Warning for the left ventricular dysfunction as well as embryo-fetal toxicity. Moreover, margenza is responsible for causing the IRRs (Infusion-related reactions). These reactions were reported by around 13% of patients treated with the agent; although, maximum cases reported were grade 2 or less in severity. Grade 3 Infusion-related reactions were experienced by around 1.5% of patients.
Margenza (margetuximab-cmkb) specifically is a HER2/neu receptor antagonist used in order to treat adult patients with metastatic HER2+ breast cancer who have received two or more prior anti-HER2 regimens (3rd line treatment), at least one of which was for the metastatic disease.
Margenzacomes in the vial form for intravenous infusion (drip) composition of margetuximab-cmkb 250 mg/10 mL.