Elevation Oncology's EO-3021 Granted FDA Fast Track for Advanced Gastric Cancer Treatment
Elevation Oncology's EO-3021 Granted FDA Fast Track for Advanced Gastric Cancer Treatment
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.
Elevation Oncology, Inc.（納斯達克股票代碼：ELEV）是一家專注於發現和開發選擇性癌症療法以治療醫療需求嚴重未得到滿足的各種實體瘤患者的創新腫瘤公司。該公司今天宣佈，美國食品藥品監督管理局（FDA）已授予差異化抗體藥物偶聯物（ADC）Fast Track稱號（FTD），用於治療晚期或轉移性胃和胃食管患者表達 Claudin 18.2 的交界處 (GC/GEJ) 癌症已在先前或之後惡化 EO-3021療法。
"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 through monotherapy dose expansion and reporting additional data from our ongoing trial in the first half of 2025, and to initiating the combination portion of our study later this year."
Elevation Oncology總裁兼首席執行官約瑟夫·費拉表示：「我們很高興獲得 EO-3021 的快速通道稱號，這標誌着人們對錶達克勞丁18.2的腫瘤患者未得到滿足的醫療需求以及 EO-3021 改善治療效果的潛力得到了令人鼓舞的認可。」「該稱號基於我們正在進行的1期臨床試驗的非臨床和初步臨床數據。正如我們在8月份宣佈的那樣，早期結果顯示，在富含Claudin 18.2的胃癌和GEJ癌子集中，經證實的總體緩解率爲42.8％。此外，我們觀察到耐受性差異，MMAE 相關毒性微乎其微，包括無中性粒細胞減少或周圍神經病變/感覺減退。我們很高興有機會加快 EO-3021 的交付，並期待在擴大單一療法劑量方面取得進展，並在 2025 年上半年報告我們正在進行的試驗的更多數據，並期待在今年晚些時候啓動我們研究的組合部分。」
Fast Track is a process designed by the FDA to facilitate the development and expedite the review of therapeutic candidates intended to treat serious or life-threatening conditions, for which nonclinical or clinical data demonstrate the potential to address unmet medical needs. Therapeutic candidates that receive FTD may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.
Fast Track 是美國食品和藥物管理局設計的一項流程，旨在促進旨在治療嚴重或危及生命的疾病的候選療法的開發和加快審查，非臨床或臨床數據表明有可能解決未滿足的醫療需求。接受FTD的候選治療藥物可能有資格與FDA進行更頻繁的互動，以討論候選人的發展計劃。如果臨床數據支持，獲得 Fast Track 認證的候選治療藥物也可能有資格獲得優先審查和加速批准。