Herceptin fails in Phase II cancer trial

Herceptin (trastuzumab), Genentech's successful breast cancer drug has failed to produce similar benefits for lung cancer patients, according to German researchers carrying out an intermediate Phase II trial.

Results, involving more than 100 patients, found that those given the drug alongside traditional chemotherapy did no better than patients treated with chemotherapy alone.

Lead investigator Ulrich Gatzemeier of Kranken-haus Grosshansdorf, Germany, said the findings were disappointing since test-tube experiments had suggested Herceptin might work in lung cancer patients with a specific gene defect. In the event, his team found very few patients with non-small-cell lung cancer (NSCLC), the commonest form of the disease, had the right genetic profile to benefit.

Herceptin, marketed by Genentech and Roche, a monoclonal antibody approved in 1998, is designed to treat cancers in patients whose tumours over-express the growth-promoting HER-2 gene. In breast cancer, it is suitable for around a quarter of patients, generating estimated worldwide revenue of around $850m in 2003, according to industry analysts.

But while over-expression is also common among many lung cancer patients, the German research team found less than 2% had sufficiently high HER-2 for Herceptin to make a difference.

'The main reason for the negative result is the very low level of strongly HER-2 positive patients,' Gatzemeier told the Reuters News Agency.

Gatzemeier, whose research was supported by Roche and published in the Annals of Oncology journal, said it made no sense to look further at Herceptin in combination with chemotherapy, since the tiny percentage of patients who might benefit made clinical trials impractical.

Lung cancer

Lung cancer, the biggest of all cancer killers in North America and Europe, has proved notoriously hard to treat and 90% of patients die within five years. NSCLC accounts for around 75% of all lung cancer cases.