GSK to test Tycerb for head and neck cancer
pharmafile | March 7, 2007 | News story | Sales and Marketing |Â Â breast cancerÂ
GlaxoSmithKline is to trial its potential blockbuster Tycerb for a new indication in head and neck cancer.
Tycerb was only submitted to EU regulators in its first indication for advanced or metastatic HER2 positive breast cancer treatment last year, but it is expected to be approved later this year and analysts predict peak sales of $1.5 billion.
The treatment is claimed to have significant benefits over Roche's Herceptin, targeting both ErbB1 and HER2 receptors within the cancer cell.
In a bid to augment its indications into difficult-to-treat tumour types, GSK has begun an international phase III trial of the drug in squamous cell carcinoma of the head and neck (SCCHN) to evaluate it in post-operative patients.
Research suggests that a quarter to one-third of advanced head and neck cancers treated with surgery and radiation therapy come back following treatment.
"There is a significant group of patients who are at high risk of disease recurrence following surgery, and they need new treatments that can be combined with standard chemoradiation therapy," said Professor Jean Bourhis, head of radiation and oncology at France's Institute Gustave Roussy.
Results from a phase I study in SCCHN suggest that 1500 mg of lapatinib taken once-daily with chemotherapy and radiotherapy is the optimal dose, with 89% of patients having a tumour response to this combination.
The drug blocks the activation of two key receptors, EGFR (ErbB1) and HER2 (ErbB2), both of which are associated with reduced survival in a variety of tumours. Large numbers of HER2 receptors are present in 20-40 per cent of tumors.
"Having already shown promise as a breast cancer treatment, we are very excited to continue investigating lapatinib in SCCHN," said Paolo Paoletti, MD, senior vice president at GSK's Oncology Medicine Development Centre. Around 600,000 people are diagnosed with SCCHN annually, including 100,800 in Europe. Some 40,000 people die from the disease each year.
In December, GSK entered the first phase III study to investigate whether adjuvant therapy with Tycerb could improve disease-free survival in women with early stage HER2 or ErbB2-positive breast cancer.
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