Data From Lung Cancer Trial Show Clear Survival Benefit
Lung Cancer Drug
Cancer drug developer Antisoma plc today announces final data from its phase II trial of AS1404 in non-small cell lung cancer. These show a very substantial survival benefit.
Patients who received AS1404 on top of standard chemotherapy had a median survival of 14.0 months, compared with 8.8 months in patients treated with chemotherapy alone. This 5.2-month difference is one of the largest ever seen in a randomised controlled trial combining a novel agent with first-line chemotherapy for lung cancer. Across the duration of the trial, patients treated with AS1404 had a 27% lower risk of dying than those receiving chemotherapy alone. Safety data from the trial were also encouraging. The addition of AS1404 to chemotherapy was well tolerated. These findings extend those announced in June and strongly support Antisoma's plans for a phase III trial in lung cancer.
The lung cancer study is one of three phase II trials of AS1404. Positive PSA response data were recently announced from a trial in prostate cancer and encouraging early data have been presented from an ovarian cancer study. Antisoma is currently in talks with a number of companies with a view to licensing AS1404.
Dr Mark McKeage of the University of Auckland, New Zealand, one of the Principal Investigators in the AS1404 lung cancer study, said: "It is great to see this large survival benefit with AS1404 in lung cancer patients. This makes me feel very optimistic as we proceed into phase III testing"
Commenting, Glyn Edwards, CEO of Antisoma, said: "Survival is the gold standard by which cancer drugs are judged and this news is therefore very exciting."
Certain matters discussed in this statement are forward looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements. These risks and uncertainties may be associated with product discovery and development, including statements regarding the company's clinical development programmes, the expected timing of clinical trials and regulatory filings. Such statements are based on management's current expectations, but actual results may differ materially.
Details of the lung cancer study
The AS1404 phase II trial in lung cancer was a randomised controlled trial which enrolled patients receiving first-line chemotherapy treatment for stage IIIb or IV non-small cell lung cancer. Patients were randomly assigned to receive either AS1404 plus standard chemotherapy (carboplatin and paclitaxel) or standard chemotherapy alone. Seventy patients were evaluable for efficacy, 34 of whom received AS1404 plus chemotherapy while 36 received chemotherapy alone. The trial was conducted at hospitals in France, Germany, Australia and New Zealand.
AS1404 (DMXAA) is a small-molecule vascular disrupting agent which targets the blood vessels that nourish tumours . The drug was discovered by Professors Bruce Baguley and William Denny and their teams at the Auckland Cancer Society Research Centre, University of Auckland, New Zealand. It was in-licensed by Antisoma from Cancer Research Ventures Limited (now Cancer Research Technology), the development and commercialisation company of the Cancer Research Campaign (now Cancer Research UK), in August 2001. CRUK had supported two phase I studies in the UK and New Zealand.
Based in London, UK, Antisoma is a biopharmaceutical company that develops novel products for the treatment of cancer. Antisoma fills its development pipeline by acquiring promising new product candidates from internationally recognised academic or cancer research institutions. Its core activity is the preclinical and clinical development of these drug candidates. Please visit www.antisoma.com for further information.