Bayer and Onyx Report Phase 3 Study Results of NEXAVAR� (sorafenib) as Adjuvant Treatment for Patients with Liver Cancer Who Have Undergone Surgery or Local Ablation

On March 11, 2014 Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced that a Phase 3 trial (NCT00692770) evaluating the investigational use of NEXAVAR (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival (Press release Amgen, MAR 11, 2014, View Source;p=RssLanding&cat=news&id=1907747 [SID:1234500257]). The safety findings were consistent with the known profile of sorafenib. Data from this study will be submitted for presentation at an upcoming scientific congress.

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Experimental breast cancer drug to be trialled in lung cancer patients

An experimental drug olaparib, originally designed to treat breast cancer, is now to be tested in patients with advanced lung cancer (Press release Cancer Research UK, MAR 11, 2014, View Source [SID:1234500252]).
Olaparib, a PARP inhibitor, will be given after chemotherapy to patients with non-small cell lung cancer (NSCLC) to see if it delays the growth of their tumor. Around half of NSCLCs have faults in one of the ways they repair DNA damage. Research has shown that adding a PARP inhibitor makes it even harder for the cancer to repair this damage. Olaparib is also being tested in phase III trials for ovarian and stomach cancers.
The phase II trial will recruit over 100 people with advanced non-small cell lung cancer at 25 hospitals around the UK. It is funded by Cancer Research UK and AstraZeneca through a National Cancer Research Network initiative and is being co-ordinated by Cancer Research UK’s Wales Cancer Trials Unit at Cardiff University and Velindre NHS Trust in Cardiff.

(Press release, New Amsterdam Sciences, MAR 10, 2014, View Source!news/nws17/B15A676B-EE12-429B-8F67-3D4B19755DBE/new-amsterdam-sciences-secures-research-and-funding-support-from-the-national-institute-of-health [SID:1234505522])

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(Report, JHL Biotech, MAR 10, 2014, View Source,%20a%20leading%20online%20provider%20of%20biopharmaceutical%20information(1).pdf [SID:1234503386])

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Successful completion of the Phase I trial of GSK1070916

On March 7, 2014 Cancer Research UK reported that Dr Nigel Blackburn, director of Cancer Research UK’s Drug Development Office, said: "It is fantastic news that this study has been successfully completed in partnership with GlaxoSmithKline. This is the first trial to conclude under Cancer Research UK’s Clinical Development Partnerships (CDP) initiative. This achievement clearly shows the CDP scheme is succeeding in providing an alternative route for companies to advance new anti-cancer drugs that would not otherwise be developed(Press release, Cancer Research Technology, MAR 7, 2014, View Source [SID1234523229])."

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Background Information

The Phase I trial was led by Professor Christopher Twelves at the Leeds and NIHR Experimental Cancer Medicine Centre (ECMC) and the Clinical Research Facility at St James’s Institute of Oncology and by Professor Iain Mcneish at the ECMC at Barts Cancer Institute in London. Cancer Research UK and GSK have agreed that pre-determined success criteria have been met, which in turn means that Cancer Research UK will receive a success payment from GSK. This was the third drug to enter Cancer Research UK’s CDP pipeline and is the first project to be completed.

The clinical trial involved GSK1070916, an inhibitor of Aurora B/C kinases that play a key role in multiple steps of cell division and are over-expressed in a range of cancers. The trial involved 36 adult patients with solid tumours and assessed the drug’s safety profile, dosing and tumour response. The drug was well tolerated and measurement of a surrogate marker of inhibition indicated on-target activity at the established maximum tolerated dose.