GOOD NEWS FROM NOVARTIS (April 12th 2007)

Glivec has been found to dramatically reduce the risk of cancer returning after surgery for Kit-positive GIST. Click here to download the full text of the NOVARTIS press release.

AN UPDATE ON OTHER CLINICAL TRIALS.

The Royal Marsden has just started a Phase II trial of Astra Zeneca's AZD2171 specifically for GIST which has proved resistant to imatinib and/or sunitinib.  Prof Judson thinks this is a "very interesting VEGF inhibitor".  He says it is probably the most effective of a whole crop of VEGF inhibitors which have been appearing over the last 18 months. VEGF provides the signalling in a tumour which helps it create a blood supply (angiogenisis). By turning it off the tumour becomes starved of blood and stops growing, or dies - at least that is the theory. Ian Judson hopes that because GIST is such a vascular tumour it may prove very effective. The biggest side effect is raised blood pressure and this means that it is not suitable for people with other problems such as heart disease.

Newcastle is starting a trial of plitidepsin (trade name Aplidin from Pharmamar) for solid tumours including GIST. This is more like a traditional chemotherapy.  It is derived from a marine organism and has shown effect in thyroid cancer. Pharmamar has another product - trabectedin (Yondelis) - which is currently seeking licensing for use in soft tissue sarcoma where it offers stability for a much higher percentage of patients with metastastic disease than anything else before it.

The pan-European adjuvant trial EORTC 62024 closed last month after recruiting 411 patients in nine months (the aim was 400 in three years !!). It has received approval to re-open and increase recruitment to 750.  Patients with a complete resection (no marginal disease or mets) are randomised to 400mg imatinib for two years, or to no treatment (which is the standard).  The aim is to answer the question about whether imatinib has value giving long-term NED and survival.

We are awaiting publication of results for the first trials of Novartis’ new drug nilotinib. This is the 'son of imatinib' drug.  There should be some Phase II data coming in the next few months, possibly at ASCO in June.

Compilation of the data from the two big trials which compared 400mg and 800mg of imatinib is now underway and publication is anticipated sometime early next year.  It will follow an update of the S0033 trial (the US version of the 400/800 comparison) which according to Dr George Demetri includes valuable data about cross-over to 800mg.

Two trials are in preparation. The first is the inevitable comparison trial between imatinib and sunitinib on diagnosis with unresectable/metastatic disease.  Both Novartis and Pfizer will be funding this trial which I understand will be international. The second is a European trial of surgery following stability with imatinib for refractory disease. I am not yet sure of what the conditions will be but the aim is to see whether getting people back to NED with imatinib/surgery is valuable for quality of life and for longevity.

Roger Wilson Sarcoma UK

Last updated April 13th 2007


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