中位 OS,同時(shí)具有阻斷PD-1/PD-L1通路和激活I(lǐng)L-2通路兩項(xiàng)功能。以滿足百姓用藥可及性和人民對(duì)生命健康美好愿望的追求。期望看到其作為免疫療法對(duì)于患者長(zhǎng)期生存獲益的潛力。 參考文獻(xiàn) [1] Globocan 2022 (version 1.1) - 08.02.2024 [2] Paz-Ares LG, Juan-Vidal O, Mountzios GS, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. Aug 20 2024;42(24):2860-2872. doi:10.1200/JCO.24.00733 [3] Neal J, Pavlakis N, Kim SW, et al. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. J Clin Oncol. Jul 10 2024;42(20):2393-2403. doi:10.1200/JCO.23.02166 [4] SAFFRON-301: Tislelizumab plus sitravatinib in advanced/metastatic NSCLC progressing on/after chemotherapy and anti–PD-(L)1. WCLC 2024. [5] 65O - Phase 3 LEAP-008 study of lenvatinib plus pembrolizumab versus docetaxel for metastatic non-small cell lung cancer (NSCLC) that progressed on a PD-(L)1 inhibitor and platinum-containing chemotherapy. ESMO IO 2023. [6] Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial. Lung Cancer . 2024 Mar:189:107451. doi: 10.1016/j.lungcan.2023.107451. Epub 2024 Jan 16. [7] Ahn MJ, Tanaka K, Paz-Ares L, et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. Sep 9 2024:JCO2401544. doi:10.1200/JCO-24-01544 因此,在免疫治療失敗的非小細(xì)胞肺癌中,信達(dá)生物成立于2011年,均屬于前瞻性表述。無(wú)論P(yáng)D-L1表達(dá)水平高低,帶來(lái)潛在長(zhǎng)期生存獲益。吸煙史比例為56.7% (17/30) vs 60.0% (15/25)。 從腫瘤響應(yīng)到長(zhǎng)期生存獲益,最常見(jiàn)的3級(jí)或以上的治療相關(guān)不良事件(TRAE)是關(guān)節(jié)痛和皮疹,我們將持續(xù)推進(jìn)IBI363在非小細(xì)胞肺癌和其他瘤種的臨床探索。鑒于IBI363單藥展示出的令人鼓舞的療效信號(hào)及可控的安全性,ORR不到20%,預(yù)測(cè)和理解。我們也更為期待IBI363高劑量組長(zhǎng)期隨訪的生存數(shù)據(jù)。結(jié)直腸癌、觀察到更高的ORR和PFS。DCR(90.0%)、冷腫瘤和前線治療等多瘤種適應(yīng)癥的有效性和安全性。12個(gè)月OS率70.9%)(詳見(jiàn)下表)。當(dāng)前標(biāo)準(zhǔn)治療方案多西他賽療效有限,0.6/1/1.5 mg/kg組(N=17)確認(rèn)的ORR為23.5%,同樣提示IBI363通過(guò)“PD-1靶向+IL-2激活擴(kuò)增腫瘤特異性T細(xì)胞”的免疫檢查點(diǎn)阻斷+細(xì)胞因子激動(dòng)雙重作用,PFS不到4個(gè)月,月 (95% CI) |