遠大醫藥(00512.HK)聯營OncoSec與Merck就TAVO™聯合KEYTRUDA®治療晚期轉移性黑色素瘤臨牀III期研究達成合作協定
格隆匯7月8日丨遠大醫藥(00512.HK)公吿，集團在腫瘤免疫領域及DNA技術研發平台OncoSec MedicalIncorporated (NASDAQ: ONCS) ("OncoSec"，為集團的一間聯營公司)宣佈已與Merck(在美國和加拿大以外的地區稱默沙東) (NYSE: MRK)達成了一項臨牀研究合作協定("合作協定")，開展白介素-12(IL-12)的質粒 DNA 藥物 TAVO™與抗 PD-1 藥物 KEYTRUDA® (pembrolizumab)聯用治療晚期轉移性黑色素瘤的全球臨牀 III 期研究(「KEYNOTE-C87 研究」)，針對難以免疫檢查點治療方案治療的晚期轉移性黑色素瘤患者，該項研究將會評估 TAVO™聯合 KEYTRUDA®治療方案與標準治療方案在患者總生存期方面的影響。
TAVO™為 OncoSec 的全球創新核心產品，通過基於編碼 IL-12 的 DNA 在腫瘤及其微環境中持續表達 IL-12，以引發身體的免疫反應，使免疫系統能夠靶向攻擊腫瘤細胞，從而達到抑制腫瘤細胞增長的目的。其治療耐藥轉移性黑色素瘤療法已於 2017 年獲得美國食品藥品管理局(FDA)授予的孤兒藥資格。目前，TAVO™已獲得進入 FDA 的快速批准通道資格，隨着其在與 KEYTRUDA®或 OPDIVO®(nivolumab)臨牀上聯用的研究進展，TAVO™有望成為治療轉移性黑色素瘤的潛在全球首創藥物。根據合作協定的條款，KEYNOTE-C87 研究計劃在美國、加拿大、歐盟和澳洲開展，計畫招募約 400 名患有 III 期或 IV 期不可切除的轉移性黑色素瘤且難以免疫檢查點治療方案治療的患者。此研究旨在支援 FDA 對於TAVO™的加速批准，同時也是支援 TAVO™全面許可上市的關鍵研究。
集團將持續佈局抗腫瘤領域，以患者需求為核心，以科技創新為驅動，加大對放射性藥物和免疫抗腫瘤全球創新產品的投入，並聯合美國的 OncoSec、澳洲的Sirtex Medical Pty Limited 和 Telix Pharmaceuticals Limited (ASX: TLX)三家全球領先的抗腫瘤醫藥公司，針對尚未滿足的臨牀需求，持續開發不同癌種的全球創新產品，豐富和完善產品管線及產業佈局，打造國際領先的放射性藥物和免疫抗腫瘤平台，整合診斷和治療，並採用"全球化運營佈局，雙循環經營發展"策略，形成國內國際雙循環聯動發展並相互促進的新格局，充分發揮集團在國內的產業優勢和研發實力，快速將國際創新產品落地，為全球腫瘤患者提供更先進更多樣的治療方案。
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