Roche claims Tarceva (erlotinib) improves overall survival of lung cancer patients after chemotherapy

14 Jul 2009

Roche announced on Monday that Tarceva improves overall survival when used immediately after initial chemotherapy in patients with advanced lung cancer.

The Swiss group said in a statement that SATURN, a Phase III study of Tarceva (erlotinib), met a key secondary endpoint of extending overall survival in patients with advanced non-small-cell lung cancer (NSCLC), who received Tarceva immediately after initial chemotherapy.

It added that a statistically significant improvement in overall survival was seen in this pre-planned final analysis of the total patient population.

The latest data follows encouraging results of SATURN presented recently at the American Society of Clinical Oncology (ASCO) meeting in June.

Data presented then on the study's primary endpoint showed that patients who received treatment with Tarceva immediately after initial chemotherapy if their cancer had not progressed, had a 41% improvement in the length of time they lived without their disease getting worse compared to placebo.

Roche said it and OSI, will use the overall survival data to support their March 2009 European and U.S. filings for use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC.

Tarceva, which is co-marketed by U.S. biotech OSI Pharmaceuticals and Roche, is approved for advanced lung cancer after at least one prior therapy has failed.

Roche said treating patients immediately following first-line chemotherapy versus waiting for the cancer to grow or spread before giving additional treatment represents a new approach in advanced NSCLC.

The statement quoted Professor Federico Cappuzzo, Istituto Clinico Humanitas IRCCS, Milan and principal investigator of the SATURN study. "This study has now not only confirmed that immediate treatment with Tarceva after initial chemotherapy delayed the progression of disease, but also importantly helped patients in the study live longer."

Roche Pharmaceuticals' CEO William Burns said: "This is the second set of data from large studies that has shown Tarceva helps patients with advanced lung cancer to live longer.

"These results confirm that Tarceva has an important role to play in improving the lives of patients earlier in the management of this devastating disease."

Tarceva is already a well established treatment in second-line management of advanced NSCLC after the failure of chemotherapy.

In addition, it is approved in the U.S. in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer and in Europe for metastatic pancreatic cancer.

Roche said the new SATURN data will be presented during the World Conference on Lung Cancer to be held between July 31 to August 4 in San Francisco.

Source: APM Health Europe