Sign Up Now!
To sign up for our newsletter or print publications, please enter your contact information below.
First Name *
Last Name *
Email Address (Verify) *
We will request your mailing address on the next page.
We will request your mailing address on the next page.

NEW DRUGS

FDA Approves Margenza for the Treatment of Metastatic HER2-Positive Breast Cancer

JHOP - February 2021 Vol 11, No 1 - FDA Updates, Breast Cancer

On December 16, 2020, the FDA approved margetuximab-cmkb (Margenza; MacroGenics) in combination with chemotherapy for the treatment of adults with metastatic HER2-positive breast cancer who have received ≥2 previous anti-HER2 regimens, of which at least 1 was for metastatic disease. The application for this approval received a fast-track designation.

“As the only HER2-targeted agent to have shown a PFS improvement versus trastuzumab in a head-to-head phase 3 clinical trial, Margenza with chemotherapy represents the newest treatment option for patients who have progressed on available HER2-directed therapies,” said Hope S. Rugo, MD, Director of Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center.

The FDA approved margetuximab based on SOPHIA, a randomized, multicenter, phase 3 clinical trial that included 536 patients with IHC (immunohistochemistry)3-positive or ISH (in situ hybridization)-amplified HER2-positive metastatic breast cancer who had received previous treatment with other anti-HER2 therapies.

Patients were randomized in a 1:1 ratio to margetuximab plus chemotherapy or to trastuzumab plus chemotherapy. Patients were stratified to treatment groups by the choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine), the number of lines of therapy received in the metastatic setting

(≤2 or >2), and the number of metastatic sites (≤2 or >2). The primary end points were progression-free survival (PFS) and overall survival. The secondary end points were objective response rate (ORR) and duration of response (DOR).

The median PFS in the margetuximab arm was 5.8 months (95% confidence interval [CI], 5.5-7) compared with 4.9 months (95% CI, 4.2-5.6) in the control arm (hazard ratio, 0.76; 95% CI, 0.59-0.98; P = .033). The confirmed ORR was 22% (95% CI, 17-27), with a median DOR of 6.1 months (95% CI, 4.1-9.1) in the margetuximab arm versus an ORR of 16% (95% CI, 12-20) in the control arm and a median DOR of 6 months (95% CI, 4.0-6.9).

The most common (>10%) adverse reactions with margetuximab plus chemotherapy were fatigue or asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia or myalgia, cough, decreased appetite, dyspnea, infusion-related reactions, palmar-plantar erythrodysesthesia, and extremity pain. Treatment with margetuximab is associated with the risks for left-ventricular dysfunction and embryo-fetal toxicity.

The recommended dose of margetuximab is 15 mg/kg by intravenous infusion over 120 minutes for the initial dose, then over a minimum of 30 minutes every 3 weeks.

Related Items
Rylaze FDA Approved as Part of a Treatment Regimen for Pediatric Leukemia and Lymphoma
JHOP - August 2021 Vol 11, No 4 published on August 17, 2021 in FDA Updates
FDA Approved Truseltiq for Metastatic Cholangiocarcinoma with the FGFR2 Biomarker
JHOP - August 2021 Vol 11, No 4 published on August 17, 2021 in FDA Updates
FDA Approves Darzalex Faspro plus Pomalyst and Dexamethasone for Multiple Myeloma
Web Exclusives published on August 10, 2021 in FDA Updates
FDA Approves Avapritinib for Advanced Systemic Mastocytosis
Web Exclusives published on August 10, 2021 in FDA Updates
Pembrolizumab plus Lenvatinib Combination Receives Regular Approval for Advanced Endometrial Carcinoma
Web Exclusives published on August 10, 2021 in FDA Updates
Padcev Receives Regular FDA Approval for Locally Advanced or Metastatic Urothelial Cancer
Web Exclusives published on August 10, 2021 in FDA Updates
FDA Alert: Pepaxto (Melphalan Flufenamide) Associated with Increased Risk of Death in Postmarketing Clinical Trial
Web Exclusives published on August 3, 2021 in FDA Updates
Lumakras First FDA-Approved Therapy for Advanced or Metastatic NSCLC with KRAS G12C Mutation
JHOP - June 2021 Vol 11, No 3 published on June 16, 2021 in FDA Updates
Rybrevant First FDA-Approved Therapy for NSCLC with EGFR Exon 20 Insertion Mutations
JHOP - June 2021 Vol 11, No 3 published on June 16, 2021 in FDA Updates
Zynlonta First FDA-Approved CD19-Directed Therapy for Large B-Cell Lymphoma
JHOP - June 2021 Vol 11, No 3 published on June 16, 2021 in FDA Updates
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.