(FOLFOX + ADI-PEG 20) 北極星 : Memorial Sloan-Kettering Cancer Center 肝癌臨床試驗 現生機

北極星發表肝癌臨床試驗結果 中央社 2016/11/29（中央社記者韓婷婷台北29日電）北極星藥業-KY獲選由ASCO主辦，於明年1月舉行的肝及腸胃道腫瘤研討會，發表ADI-PEG 20聯合FOLFOX（目前中國核准肝癌一線用藥）治療肝癌的臨床試驗結果。北極星藥業-KY執行長吳伯文表示，這次的試驗結果顯示，病患腫瘤反應率達2成以上、疾病控制率達7成以上，較標準一線療法蕾沙瓦好數倍，未來有機會取代目前肝癌一線標準療法。吳伯文說，去年失敗的肝癌臨床試驗是因為當初是申請二線用藥，病人在接受目前全球唯一核准的一線肝癌用藥蕾沙瓦失敗後進入北極星臨床試驗，但因為蕾沙瓦會使腫瘤突變產生ASS，和ADI-PEG 20的治療模式相衝突，所以當初失敗。這次ADI-PEG 20是聯合中國核准的肝癌一線用藥-FOLFOX 進行試驗，試驗結果發現效果不錯。全球有超過六成的肝癌病患在中國，此次試驗結果將有助於北極星未來開發肝癌在中國大陸市場。北極星所開發的ADI-PEG 20是一個廣效性的創新生物藥。由於作用機制不同於其他癌症用藥療效佳而且副作用輕微，本身也適合與其他癌症用藥聯合使用。自2013年起，北極星在歐美頂尖的癌症醫院啟動一系列聯合用藥的臨床試驗，在多種癌症上看到療效較標準一線用藥可以大幅提升。日前ADI-PEG 20與免疫療法聯合結果、胰臟癌聯合用藥、肺間皮癌聯合用藥，均獲多個國際腫瘤學會發表成果，此次ADI-PEG 20聯合FOLFOX治療肝癌也看到明顯療效，試驗數據再次顯示ADI-PEG 20在不同癌症治療的效果。吳伯文說，本次將發表的試驗結果是在全球最大癌症研究機構-紐約紀念斯隆-凱特琳癌症中心進行的ADI-PEG 20聯合FOLFOX用藥治療肝癌，結果顯示病患腫瘤反應率較一線用藥雷沙瓦好數倍。肝癌的病患一般帶有肝硬化的現象，因此治療後可以將肝癌病患腫瘤縮小，是相當不容易的結果。另外，由於此次試驗的病人均是接受過一線用藥雷沙瓦治療後的病人，因此，此次試驗間接證實了以聯合用藥方式可以解決雷沙瓦造成病患腫瘤細胞產生突變的問題，ADI-PEG 20聯合用藥的方式呈現不錯的成效。

Polaris Group Announces Treatment of First Patient in Phase 1 Study of ADI-PEG 20 plus FOLFOX in Advanced Gastrointestinal Malignancies    Feb 03, 2015, 13:15 ET from Polaris Group  SAN DIEGO, Feb. 3, 2015 /PRNewswire/ -- Polaris Group announced today that the first patient has been dosed in its Phase 1 trial of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) for the treatment of advanced gastrointestinal malignancies.  In addition to a global Phase 3 study in hepatocellular carcinoma (HCC) featuring ADI-PEG 20 as a monotherapy, Polaris Group is currently conducting clinical trials on ADI-PEG 20 in combination with cisplatin in melanoma and ovarian cancer, in combination with sorafenib in HCC, in combination with doxorubicin in HER2 negative breast cancer, in combination with nab-paclitaxel and gemcitabine in pancreatic cancer and in combination with cisplatin and pemetrexed in malignant pleural mesothelioma and non-small cell lung carcinoma. "FOLFOX is used in the treatment of many gastrointestinal cancers, and the combination of ADI-PEG 20 to this well-established regimen is based on numerous lines of preclinical data," said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris. "We are pleased to start another trial of ADI-PEG 20 in combination with multi-agent current first line therapy, and hope that the addition of ADI-PEG 20, which has a different mechanism of action than these standard chemotherapies, will result in both safety and added efficacy."