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              FDA 批準羅氏腫瘤免疫療法 Tecentriq 用于治療小細胞肺癌
              2019-03-21 10:55:42 來源:丁香園 瀏覽:3487

              PMLiVE 于 3 月 19 日報道,羅氏憑借其癌癥免疫療法 Tecentriq 繼續蠶食巨大的肺癌市場,現在 FDA 批準這款藥物一線用于廣泛期小細胞肺癌(ES-SCLC)治療。具體地講,這次是美國 FDA 批準 Tecentriq(atezolizumab)聯合化療用于 ES-SCLC,這使得該 PD-L1 抑制劑成為首個獲批用于廣泛期小細胞肺癌一線治療的免疫療法,填補了這類患者 20 年來無新療法的一個空白。

              SCLC 比非小細胞肺癌(NSCLC)的發病率低,但其侵襲性更強,腫瘤生長速度更快,并更早地擴散到身體其他部位。這種腫瘤對化療和放療相當敏感,但復發率高,中位生存期低,廣泛期 SCLC 的生存期通常為一年或更短,確診時腫瘤往往已經擴散到肺和鄰近淋巴結之外。三分之二的患者在確診時病情已經發生惡化,通常只有 5% 或更少的患者五年后仍然活著。

              此次 FDA 的批準基于 IMpower133 試驗的結果,試驗表明,與單獨化療相比,在化療中添加 Tecentriq 可以顯著延長患者的壽命,平均生存時間為 12.3 個月對 10.3 個月。Tecentriq 還可以將病情惡化或死亡時間延長至 5.2 個月(無進展生存期),而單獨化療為 4.3 個月。羅氏去年公布了這項試驗的關鍵結果。

              Tecentriq 將 ES-SCLC 添加到其適應癥中,可以使羅氏有機會在不與其他檢查點抑制劑競爭的情況下開拓肺癌市場的另一塊市場,尤其是默沙東的 PD-1 抑制劑 Keytruda(派姆單抗),這款藥物在 NSCLC 中占據主導地位。

              然而,默沙東并沒有落后太遠,因為該公司目前正進行其 PD-1 抑制劑的一項 3 期試驗(keynotes -604),該試驗旨在將派姆單抗與化療作為一線治療方案用于 ES-SCLC,另外,百時美施貴寶在一項 2 期試驗中也在測試其 PD-1 抑制劑 Opdivo(納武單抗)用于這一適應癥。

              與此同時,阿斯利康在 CASPIAN 研究中,也在測試其 PD-L1 抑制劑 Imfinzi(durvalumab)作為單一療法一線用于 ES-SCLC,以及與其正在研發的 CTLA4 抑制劑 tremelimumab 聯合用于該適應癥。不過,隨著羅氏這款旗艦免疫腫瘤療法新新適應癥的獲批,這將擴大其在肺癌領域的地位。

              最近,Tecentriq 與化療及羅氏腫瘤老藥阿瓦斯汀(貝伐單抗)的聯合療法被歐盟批準二線用于治療非鱗狀非小細胞肺癌,但 Tecentriq 與禮來培美曲塞作為非鱗狀非小細胞肺癌一線治療的聯合療法在一項試驗中遭遇失敗,其未能改善患者的生存期。

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