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 presentation of updated data from its Phase 2 clinical trial of margetuximab plus pembrolizumab for patients with advanced HER2+ gastric carcinoma in a poster session at the 2019 ASCO Gastrointestinal Cancers Symposium in San Francisco, California.
The poster was titled ‘Antitumor Activity of Margetuximab plus Pembrolizumab in Patients with Advanced HER2+ (IHC3+) Gastric Carcinoma.’
This Phase 2 open-label, dose escalation study evaluates the combination of margetuximab, an investigational Fc-optimized anti-HER2 monoclonal antibody, with pembrolizumab, an anti-PD-1 antibody, a regimen that is designed to coordinately engage innate and adaptive immunity for the treatment of patients with gastroesophageal cancer. The trial seeks to characterize the safety, tolerability, maximum tolerated dose, and antitumor activity of this combination. Enrolled patients had relapsed or refractory advanced HER2+ gastric or gastroesophageal junction cancer with disease progression after or resistance to treatment with trastuzumab plus chemotherapy. The 25 patients in the most recently enrolled expansion cohort had HER2+ gastric carcinoma that was 3+ by immunohistochemistry (IHC). Patients in the study were enrolled irrespective of PD-L1 expression status.
Acceptable tolerability was observed in the safety population of 95 patients, 92 of whom were treated at the recommended Phase 2 dose of 15 mg/kg for margetuximab and 200mg for pembrolizumab, both on an every three week schedule of administration. Grade 3 or higher treatment-related adverse events (TRAE) occurred in 17.9% of patients, the most common of which was infusion-related reaction (3.2%).
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.