2021-06-08
復宏漢霖斯魯利單抗注射液兩項最新臨床研究結果在 asco 2021 上首次發佈
2021年6月7日，複宏漢霖（2696.hk）宣佈公司自主開發的斯魯利單抗（hlx10）用於治療轉移性高度微衛星不穩定型或錯配修復缺陷型實體瘤和晚期宮頸癌的兩項ii期臨床試驗數據（hlx10-010-msi201和hlx10-011-cc201）在近期召開的2021美國臨床腫瘤學會（asco）年會上首次發佈。
斯魯利單抗注射液為複宏漢霖自主開發的創新型抗pd-1單抗，現時已獲得中國、美國、歐盟等國家和地區的臨床試驗準予，共計開展10項腫瘤免疫臨床試驗，全面覆蓋肺癌、食管癌、肝細胞癌、胃癌、頭頸癌等高發大瘤種。 2021年3月，斯魯利單抗注射液用於經標準治療失敗的、不可切除或轉移性高度微衛星不穩定型或錯配修復缺陷型（msi-h/dmmr）實體瘤的關鍵性ii期臨床研究達到主要研究終點，顯示出產品在該適應症上良好的療效及安全性。 現時，斯魯利單抗針對msi-h實體瘤適應症的上市註冊申請（nda）已正式獲得國家藥品監督管理局（nmpa）受理，並納入優先審評程式。
以下為斯魯利單抗（hlx10）的數據發表詳情：
hlx10-010-msi201
● 論文題目
efficacy and safety of hlx10, a novel anti-pd-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicenter, phase 2 study.
● 聯合主要研究者
秦叔逵，中國人民解放軍南京八一醫院； 李進，上海東方醫院
● 展示形式
摘要及壁報
● 摘要編號
2566
● 試驗設計
本研究是一項在標準治療失敗的、不可切除或轉移性高度微衛星不穩定型或錯配修復缺陷型實體瘤患者中進行的旨在評估hlx10療效、安全性及耐受性的單臂、開放、多中心、ii期臨床試驗。 納入的患者每兩周靜脈注射3 mg/kg hlx10，最多持續兩年，直到疾病進展，出現不可接受的毒性或患者退出。 該試驗的主要終點為獨立影像評估委員會（irrc）依據recist v1.1標準評估的客觀緩解率（orr）。
● 試驗結果
1）有效性
a）主要終點
本試驗共入組108名患者，其中68名經中心實驗室或研究中心確認msi-h的患者被納入主要療效分析人群。 主要療效分析人群中，經獨立影像評估委員會評估的orr為38.2%（95% ci: 26.7%，50.8%；2例完全緩解）。
b）次要終點
次要療效終點包括研究者評估的客觀緩解率，持續緩解時間（dor），無進展生存期（pfs），總生存期（os）。 中比特dor，pfs及os尚未達到。
2）安全性
結果表明，hlx10具有良好的安全性和耐受性。
● 結論
hlx10在標準治療失敗的msi-h/dmmr實體瘤患者中展現了顯著的抗腫瘤活性和較好的安全性。 作為一種有效的組織不確定類癌症藥物，hlx10有望改善患者的臨床療效。
hlx10-011-cc201
● 論文題目
efficacy and safety evaluation of hlx10 (a recombinant humanised anti-pd-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: a single-arm, open-label, phase 2 study.
● 主要研究者
吳令英，中國醫學科學院腫瘤醫院
● 展示形式
摘要
● 摘要編號
e17510
● 試驗設計
本研究是一項在一線標準化療失敗的晚期宮頸癌患者中評估hlx10聯合白蛋白紫杉醇療效、安全性及耐受性的單臂、開放、多中心、分兩階段的ii期臨床試驗。 納入的患者每三周靜脈輸注hlx10（4.5 mg/kg）和白蛋白紫杉醇（260 mg/m2）。 該試驗的主要終點為獨立影像評估委員會（irrc）依據recist v1.1標準評估的客觀緩解率（orr）。
● 試驗結果
試驗第一階段為安全導入及初步療效探索期，共入組21名患者，其平均綜合陽性分數（cps）為39.33。 經irrc及研究者評估的orr分別為52.4%（95% ci: 29.8%，74.3%）和42.9%（95% ci: 21.8%，66.0%）。 試驗表明，hlx10具有良好的安全性和耐受性。
● 結論
第一階段的試驗結果顯示hlx10聯合白蛋白紫杉醇在一線標準化療失敗的晚期宮頸癌患者中展現了較好的療效和安全性。
henlius has released two clinical studies of anti-pd-1 mab serplulimab for the first time at 2021 asco annual meeting
shanghai, china, june 7th, 2021 –shanghai henlius biotech, inc. (2696.hk) announced that the company released the results of two phase 2 clinical studies (hlx10-010-msi201& hlx10-011-cc201) of serplulimab injection in patients with microsatellite instability-high or mismatch repair-deficient (msi-h/dmmr) solid tumours and advanced cervical cancer (cc) at 2021 american society of clinical oncology (asco) annual meeting for the first time.
serplulimab injection is an innovative anti-pd-1 mab independently developed by henlius. up to now, serplulimab have been approved for clinical trials in china, the united states, the european union, as well as other countries and regions. a total of 10 immuo-oncology therapy clinical studies of serplulimab have been conducted to evaluate its safety and efficacy in a variety of most common tumours that cover lung cancer, esophageal cancer, hepatocellular cancer, gastric cancer, head and neck cancer, etc. in march 2021, the pivotal phase 2 study of serplulimab in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient (msi-h/dmmr) solid tumours who have progressed on or been intolerant to standard therapies met the primary endpoint, demonstrating the good efficacy and safety of serplulimab. as of now, the new drug application (nda) of serplulimab injection for the treatment of msi-h solid tumors has been accepted by the national medical products administration (nmpa) and granted priority review.
details of the two studies are as follows:
hlx10-010-msi201
● title
efficacy and safety of hlx10, a novel anti-pd-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicentre, phase 2 study.
● co-leading pi
shukui qin, md, phd, chinese people's liberation army cancer center of nanjing bayi hospital; jin li, md, phd, shanghai east hospital
● form
abstract and poster
● abstract no.
2566
● study design
this single-arm, open-label, multi-centre, phase 2 study aimed to evaluate the efficacy, safety, and tolerability of hlx10 in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumours who have progressed on or been intolerant to standard therapies. eligible patients were recruited to receive 3 mg/kg hlx10 every two weeks intravenously for up to 2 years until disease progression, unacceptable toxicity, or patient withdrawal. the primary efficacy endpoint was objective response rate (orr) assessed by independent radiological review committee (irrc) per recist v1.1.
● results
1) efficacy
a) primary endpoint
108 patients were enrolled and 68 with msi-h confirmed by central laboratory or study sites were included in the main efficacy analysis population. irrc assessed orr was 38.2% (95% ci: 26.7%, 50.8%; 2 complete response) in the main efficacy analysis population.
b) secondary endpoints
secondary efficacy endpoints included orr assessed by investigators, duration of response (dor), progression-free survival (pfs), and overall survival (os). median dor, pfs and os have not been reached.
2) safety
the results demonstrated that hlx10 was safe and well-tolerated.
● conclusion
hlx10 provides encouraging antitumor activity with a manageable safety profile in patients with msi-h/dmmr solid tumors who have progressed on or been intolerant to standard therapies. as an effective tissue-agnostic treatment, hlx10 possesses the potential to improve patients’ clinical outcomes.
hlx10-011-cc201
● title
efficacy and safety evaluation of hlx10 (a recombinant humanised anti-pd-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: a single-arm, open-label, phase 2 study.
● leading pi
lingying wu, md, phd, cancer hospital chinese academy of medical science
● form
abstract
● abstract no.
e17510
● study design
this is a single-arm, open-label, multi-centre, two-stage phase 2 study, aimed to evaluate the clinical efficacy of hlx10 in combination with albumin-bound paclitaxel for the treatment of advanced cervical cancer patients who have failed to respond to the first-line standard chemotherapy. eligible patients were enrolled and given intravenous infusion of hlx10 (4.5 mg/kg) plus albumin-bound paclitaxel (260 mg/m2) every 3 weeks. the primary efficacy endpoint was objective response rate (orr) assessed by independent radiological review committee (irrc) per recist v1.1.
● results
the stage one of this study was a safety run-in and preliminary efficacy exploration study. 21 patients were enrolled with an average combined positive score (cps) of 39.33. the orr assessed by irrc and investigators were 52.4% (95% ci: 29.8%, 74.3%) and 42.9% (95% ci: 21.8%, 66.0%), respectively. the results demonstrated that hlx10 was safe and well tolerated.
● conclusion
stage one results demonstrated a manageable safety profile and encouraging efficacy of hlx10 plus albumin-bound paclitaxel in advanced cervical cancer patients who have failed to respond to the first-line standard chemotherapy.