What is Irelands Access Position for the Many Exciting New Cancer Drugs Announced in the Last 5 Days

Ireland is well placed thanks to its national cancer research organisation – ICORG a non-profit cancer research expert group who have been working for 15 years to put Ireland on the international cancer research map and thankfully have succeeded in securing a role for Ireland in some of the most important new international research currently underway in cancer. This communication will describe five breakthrough treatments that are currently or soon to be available in Ireland through an ICORG clinical trial. Today ICORG has 58 clinical research studies open, many of these at all of Ireland’s cancer treating centres.

Breakthrough 1 of 5
Crizotinib in lung cancer; on Sunday it was announced at the European Cancer Meeting in Vienna that patients being treated with this new drug developed to treat a specific type of lung cancer (ALK positive) respond better with a significant delay in the progression of their disease. This has had a positive knock on effect on the survival of the patients in the trial, 8 of whom are from Ireland. Crizotinib controlled the disease for 5 months longer than chemotherapy with the majority of treated patients living longer than 20 months. ICORG has a new study currently open with crizotinib and available to patients all over Ireland through a national ICORG referral mechanism. ICORG were acknowledged as important contributors to this study (co-authors with many other top international cancer centres). Prof. Ken O’Byrne, the lead clinician for the study in Ireland, is the ICORG co-author. ICORG partnered with Pfizer for this research.

Breakthrough 2 &3 of 5
Dabrafenib combined with trametinib in melanoma, on Saturday at the same meeting it was announced that the combination of these two new drugs significantly improved survival in melanoma patients with advanced disease, 40% of the patients participating in the preliminary study which combined these two drugs for the first time are still doing well 12 months after joining the study with fewer side effects than would be expected with traditional treatments. ICORG collaborated on a sister study in 2011 which showed dabrafenib alone to be active in melanoma, this study was reported earlier this year, 6 Irish patients bravely participated in that study. This week the follow-up research looking at these two drugs combined in a broader group of melanoma patients will open in ICORG centres all over the country (this includes all of the main hospitals where cancer doctors who are members of ICORG work). Dr Derek Power will lead this research for. ICORG partnered with GSK for this research.

The other melanoma research story from Vienna of interest to Ireland concerns the other new melanoma drug-Ipilimumab, the researchers who completed the first study announced on Saturday that at the 4 year follow up point 19% of patients treated with Ipilimumab were still doing well, which compares favourably with the 10% that would have been expected to reach that point with the treatments used before Ipilimumab. 5 patients in Ireland participated in this study. ICORG partnered with BMS for this research. Later in 2012 ICORG will be opening a study which investigates Ipilimumab in early stage melanoma in collaboration with one of the top US academic clinical research not for profit groups called ECOG-ACRIN and have secured at least 50 places for patients from all parts of Ireland on that study.

Breakthrough 4 of 5
Regorafenib in colon cancer; last Thursday the FDA in the US announced the approval of regorafenib for the treatment of advanced colon cancer, this news came after Bayer submitted research showing the drug to be an active and important addition to the treatments used for this disease. Yesterday in Vienna the Belgian doctor who led this research Eric van Cutsem, MD updated the results of this study announcing that 24% of the patients with advanced colon cancer were alive 1 year after starting treatment with regorafenib compared with 17% of those who did not receive the drug. The current regulatory approval timelines would suggest that regorafenib will take another 6-18 months before it is licensed and available commercially in Europe. In August ICORG opened a study in all of its centres which makes regorafenib available for some advanced colon cancer patients. This study is a collaboration with researchers from the University of North Carolina, which will make the drug available to at least 50 patients in Ireland over the next two years. The first Irish patient started on the study in September. Dr Seamus O’Reilly is the ICORG investigator co-leading this initiative for ICORG.

Breakthrough 5 of 5
Pazopanib in renal cancer; yesterday it was announced that one of the largest ever research efforts in renal cancer involving more than 1100 patients showed two of the leading drugs to be similarly effective in treating advanced disease i.e. renal cancer which has spread to secondary sites. Pazopanib was shown to be an effective treatment for renal cancer but also had a better side effect profile as reported directly by the patients who took part in the research. ICORG contributed to this research effort with Dr Ray McDermott, the current ICORG chair leading the study in Ireland. In all 17 patients in Ireland joined this study. ICORG partnered with GSK for this research. ICORG currently has a second study designed by Dr McDermott open for participation at many hospitals in Ireland and the noted cancer hospital in Stockholm – Karolinska Institute also joining this Irish study. This new study has 20 patients enrolled and again is active in most hospitals in the country and will be available for the next 12-18 months. A second aim of this study is to try and identify biological markers i.e. proteins in blood and tissue which may in the future help predict which patients will benefit most from this treatment. This laboratory work is being carried out by some of Irelands leading cancer research scientists who are also members of ICORG. Dr McDermott is leading these studies for ICORG.

For further information, please contact ICORG on (01) 6677211

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