Elevation Oncology(US:ELEV) Prnewswire·2024-08-06 11:00Core Insights - Elevation Oncology announced promising initial data from the Phase 1 clinical trial of EO-3021, an antibody drug conjugate targeting Claudin 18.2, showing a 42.8% objective response rate (ORR) in a subset of gastric and gastroesophageal junction (GEJ) cancer patients [1][7] - The drug demonstrated a differentiated safety profile with minimal MMAE-associated toxicities, including no cases of neutropenia or peripheral neuropathy/hypoesthesia [1][4] - The company plans to advance into the dose expansion portion of the trial and expects to initiate combination dosing by the end of 2024 [1][10] Clinical Trial Details - EO-3021 was evaluated in a Phase 1 trial involving 32 patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, with a median age of 65 years and a median of three prior lines of therapy [3] - The trial included a dose escalation stage with doses ranging from 1.0 mg/kg to 2.9 mg/kg administered every three weeks [3] Safety and Efficacy Data - As of June 10, 2024, EO-3021 was generally well-tolerated, with no Grade 4 or 5 treatment-related adverse events reported, and less than 10% of patients discontinued due to adverse events [4] - The most common treatment-emergent adverse events included nausea (56%), decreased appetite (47%), fatigue (41%), and diarrhea (28%) [5] - Among 15 evaluable patients with Claudin 18.2 expression in ≥20% of tumor cells, the ORR was 42.8%, while in patients with <20% expression, the ORR was 0% [7][6] Future Development Plans - Elevation Oncology plans to initiate enrollment in the dose expansion portion of the trial, focusing on two doses: 2.0 mg/kg and 2.5 mg/kg [8] - The primary objective of the study is to evaluate safety, tolerability, and preliminary anti-tumor activity in patients who have progressed on or after standard therapy [9] - The company also intends to explore combination therapies with ramucirumab and dostarlimab in future cohorts [10]