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MacroGenics Announces Clinical Results from Cohort A Part 1 of Phase 2/3 MAHOGANY Study of Margetuximab in Combination with Retifanlimab in Gastroesophageal Adenocarcinoma at ESMO 2021
21 of 40 patients (53%) achieved confirmed responses by independent review, exceeding prespecified futility boundary for trial; enrollment proceeding to Part
About this update from Macrogenics, Inc.
[{"type":"text","content":"21 of 40 patients (53%) achieved confirmed responses by independent review, exceeding prespecified futility boundary for trial; enrollment proceeding to Part 2 of Cohort A78% of patients had tumor shrinkage at first scanMedian duration of response was 10.3 months as of data cutoffMargetuximab plus retifanlimab was well tolerated with Grade 3 treatment-related adverse events (TRAEs) in 19% of patients; no Grade 4 TRAEs or treatment-related deathsFindings suggest this chemotherapy-free combination, if validated and approved, may be a potential option for first-line HER2+ patients ROCKVILLE, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced results from Cohort A Part 1 of the Phase 2/3 MAHOGANY clinical trial of margetuximab. MARGENZA® (margetuximab-cmkb) is approved in HER2+ metastatic breast cancer and is being investigated as a potential first-line treatment for patients with HER2+ gastric cancer (GC) or gastroesophageal junction (GEJ) cancer in combination with a checkpoint inhibitor, with or without chemotherapy. The dataset is available in a poster titled “Margetuximab With Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A” (Poster #1379P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021. The efficacy data and safety cutoff dates were July 19, 2021 and August 3, 2021, respectively. In Cohort A Parts 1 and 2, the efficacy and safety of combining margetuximab and retifanlimab (investigational anti-PD-1 monoclonal antibody licensed to Incyte by MacroGenics) is planned to be evaluated in approximately 100 patients whose tumors are HER2+ at the 3+ level by immunohistochemical (IHC) staining, PD-L1+ (combined positive score ≥1%) and non-microsatellite instability-high (non-MSI-H). A pre-specified interim analysis assessing efficacy and safety was conducted on the first 40 non-MSI-H patients enrolled in Part 1. These data support advancement to Part 2 with plans to enroll approximately 60 additional response-evaluable non-MSI-H patients. A total of 43 HER2 3+ and PD-L1+ patients were enrolled in Cohort A Part 1 and r...