The antibody, margetuximab, aced a bridging study among Chinese patients with advanced HER2 breast cancer, with a hazard ratio for progression-free survival of 0.69 favoring the combination of margetuximab plus chemotherapy, suggesting consistent safety and efficacy as seen in the global population. Zai Lab is now plotting a BLA submission by the end of the year — one year after MacroGenics scored its first FDA approval.
MacroGenics flips over an OS dud for Margenza in turnaround from earlier data
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that Lancet Oncology has published results from a Phase 2 study of margetuximab plus pembrolizumab as a chemotherapy-free regimen for patients with advanced HER2-positive gastroesophageal adenocarcinoma (GEA) who have previously been treated with chemotherapy and trastuzumab. Margetuximab is an investigational, Fc-engineered, monoclonal antibody targeting HER2. Pembrolizumab is an anti-PD-1 monoclonal antibody.
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to margetuximab, an investigational, Fc-engineered monoclonal antibody targeting HER2 for the treatment of gastric and gastroesophageal junction cancer.
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that during the recent mid-cycle communication with the U.S. Food and Drug Administration (FDA), the FDA notified the Company that it is no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab. The FDA also stated it continues to anticipate meeting the Prescription Drug User Fee Act (PDUFA) goal date for the application review, which is December 18, 2020.
MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company has submitted a Biologics License Application (BLA) for margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2. The margetuximab BLA is for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results of the pivotal phase 3 SOPHIA study, which were first presented at the 2019 American Society of Clinical Oncology annual meeting, with updated data recently presented at the 2019 San Antonio Breast Cancer Symposium.
MacroGenics presented new, phase 3 breast cancer data from its HER2-targeting antibody margetuximab as it works to finalize its BLA.
A second pre-planned interim overall survival (OS) analysis of a Phase 3 clinical trial, SOPHIA, evaluating MacroGenics' (NASDAQ:MGNX) margetuximab, an HER2-targeting monoclonal antibody, plus chemo compared to Roche's Herceptin (trastuzumab) plus chemo in patients with HER2-positive metastatic breast cancer showed a median increase of 1.8 months (21.6 months vs. 19.8 months).
A second pre-planned interim overall survival (OS) analysis of a Phase 3 clinical trial, SOPHIA, evaluating MacroGenics' (NASDAQ:MGNX) margetuximab, an HER2-targeting monoclonal antibody, plus chemo compared to Roche's Herceptin (trastuzumab) plus chemo in patients with HER2-positive metastatic breast cancer showed a median increase of 1.8 months (21.6 months vs. 19.8 months).
MacroGenics announced positive results from Sophia, the company’s phase 3 clinical study of margetuximab in HER2-positive metastatic breast cancer patients. Margetuximab is an investigational immune-enhancing monoclonal antibody derived from the company’s proprietary Fc Optimization technology platform. The Sophia clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy.