Biotech Values

[DewDiligence]

Tarceva monotherapy trial begins in first-line NSCLC:

[Although first-line monotherapy is probably not as large a potential market as “deferred” first-line treatment following a few cycles of chemo, the first-line monotherapy market is not exactly chopped liver.]

http://tinyurl.com/4nfko

>>
LONDON November 29 (Reuters) - Scientists launched a trial on Monday to test whether a new drug works as an initial treatment against the most common form of lung cancer.

The drug Tarceva, which was developed by Roche Holding AG, Genentech Inc and OSI Pharmaceuticals Inc, was recently approved in the United States.

Scientists at the charity Cancer Research UK and University College London (UCL) plan to test the drug on 664 patients with advanced non-small cell lung cancer that is not suitable for traditional treatment.

"Conventional chemotherapy is of limited use against advanced lung cancer," said chief investigator Dr Siow Ming Lee. "Tumor cells quickly become resistant to treatment, while chemotherapy doesn't properly distinguish between cancerous cells and healthy ones and has too many side effects for many very ill lung cancer patients to cope with."

Tarceva is one of a new generation of so-called 'smart' cancer drugs. The once-daily pill blocks the action of a molecule called an epidermal growth factor receptor (EGFR) which relays instructions to cells to grow and divide.

As well as monitoring the progress of patients, the scientists will analyze their tumors and the type and amount of EGFR in their bodies to see whether it determines response to the drug.

"Carrying out large-scale trials like this will play a crucial role in evaluating the new smart cancer drugs and getting the most effective ones into the clinic as soon as possible," Lee added in a statement.

Lung cancer is the most common tumor worldwide, with 900,000 new cases each year in men and 330,000 in women, according to the International Agency for Research on Cancer (IARC).

Non-small cell lung cancer accounts for about 75 percent of all lung cancer cases. Patients are often not diagnosed until the disease is in an advanced stage.

The trial will be conducted in about 100 centers in Britain. Patients will be randomly selected to receive Tarceva or a dummy pill and radiotherapy if needed. The scientists hope to complete the trial in about a year.

"If it works it might be a standard treatment," said Lee.
<<