AstraZeneca's Blockbuster Cancer Drug Imfinzi Flunks As Follow-Up In Type Of Early-Stage Lung Cancer, But Hits Primary Goal In Phase 3 Bladder Cancer Study
AstraZeneca's Blockbuster Cancer Drug Imfinzi Flunks As Follow-Up In Type Of Early-Stage Lung Cancer, But Hits Primary Goal In Phase 3 Bladder Cancer Study
On Tuesday, AstraZeneca Plc (NASDAQ:AZN) released topline data from the ADJUVANT BR.31 Phase 3 trial, sponsored by the Canadian Cancer Trials Group.
阿斯利康公司（NASDAQ:AZN）週二發佈了加拿大癌症試驗協作組織贊助的ADJUVANT BR.31第3階段試驗的最終數據。
The data showed that Imfinzi (durvalumab) did not achieve statistical significance for the primary endpoint of disease-free survival versus placebo in early-stage non-small cell lung cancer (NSCLC) after complete tumor resection in patients whose tumors express PD-L1 on 25% or more tumor cells.
數據顯示Imfinzi（durvalumab）在早期非小細胞肺癌（NSCLC）患者中，在所有腫瘤細胞的PD-L1表達量達到25%或更高水平且已完成所有腫瘤切除手術的患者中，與安慰劑相比，未能實現疾病無進展存活期的主要終點統計學意義。
"We are disappointed in the ADJUVANT BR.31 results," said Susan Galbraith, executive vice president of oncology research and development at AstraZeneca.
阿斯利康公司腫瘤研究和開發執行副總裁Susan Galbraith表示：“我們對ADJUVANT BR.31的結果感到失望。”
The safety profile for Imfinzi was consistent with its known safety profile, and no new safety concerns were reported.
Imfinzi的安全性與已知的安全性相一致，沒有報道新的安全問題。
Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase 3 trial.
Imfinzi是唯一獲批用於未切除的III期非小細胞肺癌患者的免疫療法產品，並且是基於PACIFIC第3階段試驗的治療標準。
Imfinzi is also being investigated as monotherapy and in combinations in several other early-stage lung cancer settings, including in medically inoperable or unresected Stage I-II NSCLC (PACIFIC-4) and unresectable, Stage III NSCLC (PACIFIC-5, 8 and 9).
Imfinzi還正在多個早期肺癌環境中作爲單一療法和聯合療法進行研究，包括在醫學上無法手術或未切除的I-II期NSCLC（PACIFIC-4）和不可切除的III期NSCLC（PACIFIC-5,8和9）中。
In April, the European pharma giant shared data from the ADRIATIC Phase 3 trial. Imfinzi demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival and progression-free survival compared to placebo in limited-stage small-cell lung cancer patients.
今年4月，這家歐洲製藥業巨頭分享了ADRIATIC第3階段試驗的數據。Imfinzi在有限期小細胞肺癌患者中展示了在總體生存率和無進展存活期的雙重主要終點方面與安慰劑相比的統計學顯着和臨床上有意義的改善。
AstraZeneca also shared high-level results from the NIAGARA Phase 3 trial showing Imfinzi in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy for muscle-invasive bladder cancer.
阿斯利康還分享了NIAGARA Phase 3的高水平結果，顯示Imfinzi與化療聯合使用，在肌侵襲性膀胱癌的新輔助化療方面，在事件無進展存活期和總體生存期的主要次要終點方面，比新輔助化療治療顯示出了統計學上顯着和臨床上有意義的改善。
Patients were treated with Imfinzi in combination with neoadjuvant chemotherapy before cystectomy (surgery to remove the bladder), followed by Imfinzi as adjuvant monotherapy.
在膀胱切除術（切除膀胱手術）前，患者接受Imfinzi和新輔助化療的聯合治療，然後採用Imfinzi作爲輔助單一療法。
The addition of Imfinzi did not increase the discontinuation rate due to adverse events and did not compromise patients' ability to complete surgery compared to neoadjuvant chemotherapy alone.
增加Imfinzi並不會由於不良事件而增加停藥率，也不會影響患者完成手術和新輔助化療治療之間的過渡。
Concurrently, Japan approved AstraZeneca's Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy as the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated NSCLC whose tumors have exon 19 deletions or exon 21 mutations.
與鉑金類化療聯合使用，Tagrisso（osimertinib）已被日本批准作爲局部晚期或轉移性表皮生長因子受體突變的NSCLC成人患者的一線治療。這些腫瘤含有外顯子19缺失或外顯子21突變。
Price Action: At the last check on Tuesday, AZN shares were up 0.44% at $79.72.
週二最後一次查詢顯示，AZN股票上漲0.44％，至79.72美元。
Image by Robert Way via Shutterstock
圖像來自Shutterstock的Robert Way
譯文內容由第三人軟體翻譯。