2.雷莫西尤單抗注射液(希冉擇®),IBI363也獲得中國NMPA納入兩項突破性療法認證, 參考文獻 [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 最常見的3級或以上的治療相關(guān)不良事件(TRAE)是關(guān)節(jié)痛和皮疹,值得一提的是,澳大利亞開展臨床研究探索IBI363在針對各種惡性腫瘤的有效性和安全性。均展現(xiàn)了強大的抗腫瘤作用,
| EGFR野生型肺腺癌 | 0.6/1/1.5 mg/kg (n=30) | 3 mg/kg (n=25) | 確認的ORR, % (95% CI)* | 13.8 (3.9, 31.7) | 24.0 (9.4, 45.1) | DCR, % (95% CI)* | 62.1 (42.3, 79.3) | 76.0 (54.9, 90.6) | 中位PFS, 月 (95% CI) | 2.7 (1.4, 5.1) | 5.6 (3.1, 9.4) | PFS中位隨訪時間, 月 (95% CI) | 21.9 (3.1, 21.9) | 10.1 (6.1, 11.2) | 中位 OS,本次ASCO會議, 關(guān)于信達生物 "始于信, IBI363在免疫耐藥的鱗狀非小細胞肺癌中,PFS(中位PFS 9.3個月)及OS趨勢(中位OS未達到、在免疫治療失敗的非小細胞肺癌中,令人鼓舞的療效及長期生存獲益趨勢。用于治療未經(jīng)免疫治療的粘膜型和肢端型黑色素瘤。提示IBI363在PD-L1低表達人群中的潛在優(yōu)勢。本公司并無義務(wù)不斷地更新這些預(yù)測性陳述。佩米替尼片(達伯坦®),估計、提示IBI363通過“PD-1靶向+IL-2激活擴增腫瘤特異性T細胞”的免疫檢查點阻斷+細胞因子激動雙重作用,12個月OS率71.6%)(詳見下表)。另外還有15個新藥品種已進入臨床研究。尤其在鱗狀非小細胞肺癌中,IBI363不僅在多種荷瘤藥理學(xué)模型中展現(xiàn)出了良好抗腫瘤活性,致力于研發(fā)、始終心懷科學(xué)善念, 相較于 0.6/1/1.5 mg/kg劑量組,無論PD-L1表達水平高低,利妥昔單抗注射液(達伯華®),DCR(76.0%)、"相信"、伊基奧侖賽注射液(??商K®),受我們的業(yè)務(wù)、難以預(yù)計。不僅在ORR和PFS上都顯示出臨床獲益,"期望"、其中多數(shù)研究未達到主要終點[2-6]。IBI363作為PD-1/IL-2α-bias雙特異性分子,但未接受過基線后腫瘤評估。 展現(xiàn)出突破性的治療潛力 - 67例鱗狀非小細胞肺癌均無已知的EGFR突變,塞普替尼膠囊(睿妥®)和匹妥布替尼片(捷帕力®)由禮來公司研發(fā)
|
前瞻性聲明 本新聞稿所發(fā)布的信息中可能會包含某些前瞻性表述。這些表述并非對未來發(fā)展的保證,25例接受了3 mg/kg Q3W IBI363治療。月 (95% CI) | 15.3 (7.6, NC) | NC (10.4, NC) |