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Amgen Presents First Clinical Data for AMG 757 at SITC 2020
Data Marks the First Proof of Concept for a BiTE® Molecule in Thoracic Malignancy and Further Demonstrates Potential of BiTE® Immuno-Oncology Platform in
About this update from Amgen Inc.
[{"type":"text","content":"Data Marks the First Proof of Concept for a BiTE® Molecule in Thoracic Malignancy and Further Demonstrates Potential of BiTE® Immuno-Oncology Platform in Solid Tumors\n Data From Four Additional Immuno-Oncology Molecules Will Also be Featured\n\n\nTHOUSAND OAKS, Calif., Nov. 9, 2020 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the first presentation of AMG 757 Phase 1 clinical safety and efficacy data in relapsed or refractory small cell lung cancer (SCLC). AMG 757 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE®) molecule targeting delta-like ligand 3 (DLL3). The DLL3 protein is overexpressed on the cell surface of SCLC tumors and minimally expressed in normal tissues.1 Data will be featured during a live oral presentation on Nov. 12 at the Society for Immunotherapy of Cancer's (SITC) 35th Annual Meeting being held virtually. \n\"These AMG 757 proof of concept data in small cell lung cancer and the recently presented AMG 160 data in prostate cancer provide encouraging evidence of the BiTE platform's clinical activity in solid tumors,\" said David M. Reese, M.D., executive vice president of Research and Development at Amgen. \"AMG 757 is a half-life extended BiTE immuno-oncology molecule targeting DLL3, which is an attractive target due to its differential expression in small cell lung cancer. Small cell lung cancer is a large unmet medical need globally, and yet treatment options have not advanced significantly in decades.\"\nThis interim analysis of the Phase 1 dose escalation study evaluated 40 patients with relapsed/refractory SCLC at a dose of up to 10 mg every two weeks. In this study, AMG 757 demonstrated an acceptable safety profile and showed preliminary evidence of anti-tumor activity. Among 38 patients with evaluable disease, 16% (6) had confirmed partial response, 29% (11) had stable disease, and 3% (1) had unconfirmed partial response. Five of the six responses are on-going with a median follow-up of 8.8 months. The maximum tolerated dose for AMG 757 has not been reached and dosing optimization is ongoing. \nCytokine release syndrome (CRS) was the most common treatment-related adverse event (AE) reported in 43% (17) of patients. All CRS events were grade 1 (30%) or 2 (13%), typically occurred in cycle 1, and did not recur in subsequent cycles. All CRS events were reversible, ma...