For Immediate Release New treatment option for lung cancer Friday 26 June 2009 Introduction In a major step towards personalised medicine for lung cancer, a new oral drug treatment has been shown to be highly effective in treating lung cancer patients whose tumours carry a genetic change called EML4ALK. In a clinical trial conducted at the Peter MacCallum Cancer Centre, and at a handful of other centres around the world, PF02341066, a new oral drug treatment caused the shrinking of the majority of tumours in lung cancer patients whose tumours tested positive for EML4ALK. Description of the Science Only two years ago scientists discovered that an important subset of lung cancer patients have tumours containing a genetic change called EML4ALK. This genetic change, which is only present in tumour cells and not in normal cells, arises as a result of a gene rearrangement on chromosome 2 which causes the fusion of part of a gene called EML4 (Echinoderm Microtubule associated protein Like protein 4) with the active portion of a gene called ALK (Anaplastic Lymphoma Kinase). Abnormal activation of ALK then drives the growth and proliferation of tumour cells that have EML4ALK. Although the change only affects approximately 4% of all lung cancers it appears to be more frequent in young patients, patients who have never smoked, and those with a tumour type called adenocarcinoma. PF02341066, originally developed by the pharmaceutical company Pfizer originally as an inhibitor of another cancer target called mesenchymal epithelial transition growth factor (c-met) was found to be a very potent inhibitor of ALK. It is the first of a new class of drugs that acts to inhibit the activity of ALK in cancer cells to be tested in clinical trials. The Clinical Trial In a world first clinical trial investigators at Peter MacCallum Cancer Centre and at centres in the United States and South Korea tested the effects of PF02340166 in a phase I clinical trial. Dr Ben Solomon, the head of the lung medical oncology service, was the Principal Investigator at the Australian centre involved in the trial. Preliminary results were recently presented at the American Society for Clinical Oncology (ASCO) in Orlando, Florida. Of particular note, outcome data was released for the first 19 patients with EML4ALK positive non small cell lung cancer treated at the recommended dose of 250 mg twice daily. Key findings were: - The drug was well tolerated with mild nausea and vomiting being the only major side-effect. - Responses sometimes dramatic were observed: 10/19 (53%) had Partial responses (greater than 30% tumour regression by RECIST (Response Evaluation Criteria in Solid Tumours) criteria) and 5/19 had stable disease - Duration of response has lasted from 8+ weeks to 40+ weeks. Dr Ben Solomon, the Australian Principal Investigator for this clinical trial is cautiously optimistic about the findings of the trial: “The very impressive activity of PF02341066 in lung cancers with the ALK gene rearrangement is a significant step forward in targeted therapy for patients with lung cancer. What is particularly exciting is that a genetic change identified only 2 years ago can already be effectively targeted. These encouraging results highlight the importance of lung cancer patients, particularly if they have never smoked having their tumours tested for EML4ALK and other potentially treatable genetic changes.” Peter Mac patient, Paul a 43 year old lifelong never smoker from country Victoria, was diagnosed with lung cancer in 2006. His tumours had grown despite previous chemotherapy and had spread from his lungs to other sites including his liver and bones. Paul’s oncologist arranged for a biopsy to be performed and referred him to Peter Mac for EML4ALK testing. Paul’s tumour was found to have the genetic change and he enrolled on the PF02341066 clinical trial. Since going on to the trial, Paul’s tumour has shown a dramatic shrinkage which is apparent on both CT and PET scans and Paul states that this is the best he has felt since his diagnosis with lung cancer. About Lung cancer: Each year in Australia just over 9,000 people will be diagnosed with lung cancer and about 7,400 people will die of the disease making lung cancer the deadliest cancer in Australia and worldwide. Over 85% of lung cancers are classified as non small cell lung cancer. The majority of cases of non small cell lung cancer are associated with smoking, but at least 15% of cases occour in non-smokers. Summary- PF02341066 shows significant activity in lung cancer patients with EML4ALK - The trial continues at Peter Mac and a phase III clinical trial is planned for later this year - Lung cancer patients (particularly non-smokers or light smokers with adenocarcinoma) should be tested for EML4ALK. For more information about the clinical trial and about testing for EML4ALK patients can contact Dr. Ben Solomon at ALK@petermac.org What: When: Where: New treatment option for lung cancer Friday 26 June, 9:30 am Department of Haematology and Medical Oncology, Seminar Room, Level 5, Peter MacCallum Cancer Centre Interview and photo opportunities available with doctors and a patient who is currently enrolled in this trial.