BOSTON , Sept. 23, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV ), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that the U.
S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.
"We are delighted to receive Fast Track designation for EO-3021, which marks an encouraging recognition of the unmet medical need in patients with Claudin 18.2-expressing tumors, as well as the potential for EO-3021 to deliver improved therapeutic outcomes," said Joseph Ferra , President and Chief Executive Officer of Elevation Oncology. "This designation is based on nonclinical and initial clinical data from our ongoing Phase 1 clinical trial.
As we announced in August, early results showed a confirmed overall response rate of 42.8% in a Claudin 18.2-enriched subset of gastric and GEJ cancer.
In addition, we observed differentiated tolerability, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy/hypoesthesia. We are grateful for the opportunity to potentially expedite the delivery of EO-3021 and look forward to advancing throug.