Tycerb in landmark cancer trial
pharmafile | December 15, 2006 | News story | Sales and Marketing |
GlaxoSmithKline's Tycerb has entered a landmark global trial in the treatment of aggressive breast cancer.
This will be the first phase III study to investigate whether adjuvant therapy with Tycerb (lapatinib) will improve disease-free survival in women with early-stage HER2 or ErbB2- positive breast cancer – a particularly virulent form of the disease.
More than 3,000 women from 30 countries will be enrolled in the TEACH (Tycerb(R) Evaluation After Chemotherapy) trial, the first to investigate the use of a dual inhibitor that blocks the action of both ErbB1 and HER2 receptors within the cancer cell.
Both these receptors are associated with rapid cell proliferation and tumour growth.
Tycerb is already showing great promise. Better-than-expected results for its use in advanced breast cancer led to trials being halted, to allow more women to benefit from the treatment.
The drug is now under review by regulatory authorities in the EU and the US, and could have significant benefits over its much-publicised rival, Roche's Herceptin, because it targets both ErbB1 and HER2 receptors.
It is also a small molecule drug, taken in pill form, making it easier to manufacture and more convenient for patients compared to Herceptin, which is administered intravenously.
Dr Paul Goss, director of Breast Cancer Research at the Massachusetts General Hospital Cancer Centre, said: "Women who have HER2-positive breast cancer are at a high risk of the disease returning, which is of great concern to patients and physicians."
Goss, who proposed the TEACH study and will chair the international steering committee, added: "The landmark study will be the first to investigate the use of a dual ErbB1 and HER2 inhibitor as an adjuvant for patients with this form of breast cancer."
By the time women are first diagnosed with breast cancer, between 10-20% are already in the advanced stages of the disease, with either locally advanced tumours or a metastatic tumour spreading the cancer to other organs.
At present, the median survival time for these patients is only two years – but GSK is hoping that Tycerb will further extend patients' life expectancy.
