Millennium reports progress in lung cancer study

The primary objective of the phase II trial is to determine the efficacy of the investigational agent in terms of tumor response rate in patients with advanced bronchioloalveolar carcinoma (BAC) who have progressed after treatment with up to two previous rounds of chemotherapy, one of which must be AstraZeneca’s Iressa or OSI Pharmaceuticals’ Tarceva.

Approximately 30,000 patients in the US have BAC. These patients represent approximately 20% of all non-small cell lung cancer (NSCLC) patients and typically respond poorly to chemotherapy treatments used for treating other forms of NSCLC. Data suggest that the incidence of BAC is increasing, notably in younger, non-smoking women. Despite reports of prolonged survival, BAC remains incurable, with the vast majority of patients dying of respiratory failure or pneumonia within five years of diagnosis.

“While some patients with BAC are able to respond to therapies currently on the market, there is a subset of patients who try and fail on several rounds of chemotherapy, which can be a devastating process,” said Dr Howard West, the lead researcher on the trial, affiliated with the Swedish Cancer Institute. “This trial provides us with an additional opportunity to treat these patients while investigating the overall response rate for patients treated with this therapy.”

The trial will enroll up to 150 male and female patients at 40 centers in the US, and 10 sites in Europe and Canada. Patients will receive the investigational drug by injection twice per week for two weeks followed by a week of rest. These three-week treatment cycles will be repeated as long as the patients’ doctor determines that the injections may continue.