AstraZeneca's new lung cancer drug significantly prolongs survival and arrives at the end of phase 3
May 28, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Today, AstraZeneca and its global biologics research and development department, MedImmune, announced the positive results of the overall survival (OS) of phase 3 clinical trials of PACIFIC. The study evaluated the efficacy of Imfinzi (durvalumab) in patients with stage III non-small cell lung cancer (NSCLC) who were not surgically resected. These patients did not progress after receiving platinum-based chemotherapy and radiation therapy.
Lung cancer is one of the most serious cancer deaths in the world, with NSCLC being the most common type. Stage III NSCLC accounts for about one-third of all NSCLC morbidity, and it is estimated that 2017 affected about 105,000 patients in eight countries (China, France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States). Most patients with stage III NSCLC are diagnosed as unresectable, and the standard treatment for these patients is chemotherapy and radiation, followed by active monitoring. The prognosis of these patients is not optimistic, and the disease is at risk of deterioration at any time.
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, counteracts tumor immune evasion strategies, and releases inhibition of immune responses. In 2017, the drug was approved by the US FDA to treat patients with locally advanced or metastatic bladder cancer. In February of this year, the FDA decided to expand Imfinzi's indications for patients with stage III NSCLC who were unable to undergo surgical resection but who did not progress under current chemoradiotherapy.
PACIFIC is a randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial evaluating the efficacy of Imfinzi in patients with stage III NSCLC who cannot be surgically resected. These patients have not progressed after receiving platinum-based chemotherapy and radiation therapy. . A total of 713 patients were enrolled in the study. The primary endpoints were progression-free survival (PFS) and OS, and secondary endpoints included landmark PFS and OS, overall response rates, and duration of remission.
The data released this time is a mid-term analysis of the plan conducted by the Independent Data Monitoring Committee. The OS of patients receiving Imfinzi was statistically and clinically significantly improved compared to placebo and reached the second of the two primary endpoints of the study. Data from the first primary endpoint, PFS, was released in May last year, demonstrating a median improvement of 11.2 months. In addition, the safety and tolerability characteristics of Imfinzi are consistent with the PFS analysis report. AstraZeneca plans to announce the specific results of the PACIFIC trial at the upcoming medical conference.
Dr. Sean Bohen, Executive Vice President and Chief Medical Officer of AstraZeneca Global Drug Development, said: "The mid-term analysis of PACIFIC clinical trials shows positive overall survival data, which provides more evidence that Imfinzi can bring clinical benefits to patients in the early stage of lung cancer. Evidence of convincing. We look forward to sharing these results with health regulators to support ongoing regulatory interactions and update Imfinzi's label with these important data."
We congratulate Imfinzi on arriving at the second major end point of the study and look forward to seeing specific results on the OS at the medical conference.
Reference materials:
[1] Imfinzi major improves overall survival in the Phase III PACIFIC trial for unresectable Stage III non-small cell lung cancer
[2] Astra Zeneca caps its big win in lung cancer with positive survival data for Imfinzi — and what a relief it is
[3] WuXi PharmaTech - New immunotherapy for lung cancer, Imfinzi, approved by the FDA
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