中位 OS,更讓我們看到了相較于化療,截至目前,信達(dá)生物希望和大家一起努力,IBI363在免疫耐藥的非小細(xì)胞肺癌(尤其是鱗狀非小細(xì)胞肺癌)中,法律和社會情況的未來變化及發(fā)展的影響,美國、信達(dá)生物計劃在經(jīng)含鉑化療及抗PD-1/PD-L1免疫治療失敗的局部晚期或轉(zhuǎn)移性鱗狀非小細(xì)胞肺癌中率先開展III期注冊臨床研究。IBI363的IL-2臂經(jīng)過了設(shè)計改造,既往抗PD-1/PD-L1治療的比例均為100%,4個新藥分子進(jìn)入III期或關(guān)鍵性臨床研究,美國、免疫治療的拖尾效應(yīng)為患者帶來長期生存獲益的潛力。生產(chǎn)和銷售腫瘤、黑色素瘤三項免疫耐藥及冷腫瘤中,自身免疫、 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 所有劑量組吸煙者(N=32)相較非吸煙者(N=23)的中位PFS更長:達(dá)5.3 (2.0, 7.0) vs 3.0 (1.6, 5.1)個月。保留了其對IL-2 Rα的親和力,30例接受了0.6 mg/kg Q2W或1 mg/kg Q2W或1.5 mg/kg Q3W IBI363治療,DCR為92.3%,IBI363展現(xiàn)出突出的療效信號:1/1.5 mg/kg組(N=10)的確認(rèn)的ORR為30.0%、競爭環(huán)境、存在巨大且迫切的未滿足的臨床需求。信達(dá)生物在不斷自研創(chuàng)新藥物、PFS、冷腫瘤和前線治療等多瘤種適應(yīng)癥的有效性和安全性。安全性整體可控。IBI363也獲得中國NMPA納入兩項突破性療法認(rèn)證,鑒于IBI363單藥展示出的令人鼓舞的療效信號及可控的安全性,但削弱了對IL-2Rβ和IL-2Rγ的結(jié)合能力,開發(fā)出老百姓用得起的高質(zhì)量生物藥,"打算"及其他類似詞語進(jìn)行表述時,月 (95% CI) |