share_log

康方生物：自願公告 - AK112 – 303達到PFS優效顯著陽性結果依沃西對比帕博利珠單藥一線治療PD-L1+的NSCLC的三期臨床結果具有統計學顯著意義和重大臨床獲益，HR值顯著優於預期

AKESO: VOLUNTARY ANNOUNCEMENT - AK112-303 REACHED PRIMARY ENDPOINT OF PFS SUPERIORITYIVONESCIMAB DEMONSTRATED A STATISTICALLY SIGNIFICANTAND CLINICALLY MEANINGFUL SUPERIORITYAS FIRST LINE MONOTHERAPY FOR PD-L1+ NSCLCVERSUS PEMBROLIZUMAB, HAZARD RATIO SIGNIFIC

HKEX ·  May 31 06:33

Summary by Futu AI

康方生物科技（開曼）有限公司宣布，其自主研發的雙特異性抗體新藥依達方®（依沃西注射液）在對抗PD-L1表達陽性的非小細胞肺癌（NSCLC）的三期臨床試驗中取得顯著成效。該試驗名為AK112–303（HARMONi-2），結果顯示依沃西在無進展生存期（PFS）上優於帕博利珠單藥一線治療，尤其在PD-L1低表達和高表達患者群體中。此外，依沃西在各個亞組患者中均顯示出強陽性結果，並且安全性良好，無新的安全性信號。398例受試者中，PD-L1 TPS 1–49%佔比為57.8%，PD-L1 TPS≥50%佔比為42.2%，與真實世界患者表達水平分布一致。康方生物將在即將舉行的全球學術會議上公布更多詳細數據。依沃西已於2024年5月24日獲得中國國家藥品監督管理局批准上市，並有多項III期臨床研究正在進行。康方生物主席兼執行董事夏瑜博士於2024年5月31日發布此消息。
康方生物科技（開曼）有限公司宣布，其自主研發的雙特異性抗體新藥依達方®（依沃西注射液）在對抗PD-L1表達陽性的非小細胞肺癌（NSCLC）的三期臨床試驗中取得顯著成效。該試驗名為AK112–303（HARMONi-2），結果顯示依沃西在無進展生存期（PFS）上優於帕博利珠單藥一線治療，尤其在PD-L1低表達和高表達患者群體中。此外，依沃西在各個亞組患者中均顯示出強陽性結果，並且安全性良好，無新的安全性信號。398例受試者中，PD-L1 TPS 1–49%佔比為57.8%，PD-L1 TPS≥50%佔比為42.2%，與真實世界患者表達水平分布一致。康方生物將在即將舉行的全球學術會議上公布更多詳細數據。依沃西已於2024年5月24日獲得中國國家藥品監督管理局批准上市，並有多項III期臨床研究正在進行。康方生物主席兼執行董事夏瑜博士於2024年5月31日發布此消息。
Kangfang Biotechnology (Cayman) Co., Ltd announced that its independently developed new dual-specific antibody Idapong® (Ivosian injection) has achieved significant results in a three-phase clinical trial against PD-L1-positive non-small cell lung cancer (NSCLC). The trial, called AK112—303 (Harmoni-2), showed that ivosy was superior to first-line treatment with PD-L1 on progression-free survival (PFS), especially in the PD-L1 low-expression and high-expression patient populations. IN ADDITION, IVOSI SHOWED STRONG POSITIVE RESULTS IN EACH SUBGROUP OF PATIENTS WITH GOOD SAFETY AND NO NEW SAFETY SIGNALS. Among 398 subjects, PD-L1 TPS 1— 49% accounted for 57.8%, and PD-L1 TPS≥ 50% accounted for 42.2%, consistent with real-world patient expression levels. More detailed data will be announced at the upcoming Global Academic Conference on Kangfang Biology. IVOSI WAS APPROVED BY CHINA'S NATIONAL DRUG ADMINISTRATION ON MAY 24, 2024, AND SEVERAL PHASE III CLINICAL STUDIES ARE UNDERWAY. Dr. Xia Yu, Chairman and Executive Director of Kang Fang Bios, issued this news on May 31, 2024.
Kangfang Biotechnology (Cayman) Co., Ltd announced that its independently developed new dual-specific antibody Idapong® (Ivosian injection) has achieved significant results in a three-phase clinical trial against PD-L1-positive non-small cell lung cancer (NSCLC). The trial, called AK112—303 (Harmoni-2), showed that ivosy was superior to first-line treatment with PD-L1 on progression-free survival (PFS), especially in the PD-L1 low-expression and high-expression patient populations. IN ADDITION, IVOSI SHOWED STRONG POSITIVE RESULTS IN EACH SUBGROUP OF PATIENTS WITH GOOD SAFETY AND NO NEW SAFETY SIGNALS. Among 398 subjects, PD-L1 TPS 1— 49% accounted for 57.8%, and PD-L1 TPS≥ 50% accounted for 42.2%, consistent with real-world patient expression levels. More detailed data will be announced at the upcoming Global Academic Conference on Kangfang Biology. IVOSI WAS APPROVED BY CHINA'S NATIONAL DRUG ADMINISTRATION ON MAY 24, 2024, AND SEVERAL PHASE III CLINICAL STUDIES ARE UNDERWAY. Dr. Xia Yu, Chairman and Executive Director of Kang Fang Bios, issued this news on May 31, 2024.
Helpful
Not Helpful

This announcement is a separate document:

Doc 1     View Translation

The translation is provided by third-party software.


The information provided by Futu AI is automatically generated by third-party artificial intelligence (AI) software based on news content. It is only available to users located outside of China mainland.


The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it.
    Heat List
    US
    SymbolLatest Price% Chg

    No Data

    Hot News
    Updated