Study Compares Tarceva, Gemcitabine to Gemcitabine Alone

OSI Pharmaceuticals, Genentech and Roche have announced that a randomized Phase III clinical study of Tarceva plus gemcitabine chemotherapy in patients with locally advanced or metastatic pancreatic cancer met its primary endpoint by demonstrating a statistically significant 23.5 percent improvement in overall survival when compared to patients receiving gemcitabine plus placebo.

Tarceva (erlotinib) is the first drug shown in a Phase III trial to prolong survival when added to the standard of care (gemcitabine) in the treatment of patients with previously untreated advanced pancreatic cancer.

The study data demonstrated an improvement in overall survival for patients receiving Tarceva plus gemcitabine compared to patients receiving gemcitabine plus placebo. Twenty-four percent of patients receiving Tarceva plus gemcitabine were alive after one year compared to 17 percent of patients receiving gemcitabine plus placebo. Median survival in the Tarceva plus gemcitabine arm was 6.4 months compared to 5.9 months in the gemcitabine plus placebo arm. An exploratory analysis of survival by pre-treatment characteristics also showed that patients with metastatic disease and patients with poor performance status derived a survival benefit. Progression-free survival in the Tarceva plus gemcitabine arm also was significantly improved, although there was virtually no difference in tumor response (9 percent in patients receiving Tarceva plus gemcitabine versus 8 percent in the gemcitabine plus placebo arm).

A preliminary analysis of the safety data did not reveal any unexpected safety signals beyond that seen in previous studies of Tarceva in both monotherapy and combination settings. As expected, rash and diarrhea were the principal Tarceva-related side effects seen in the study. Rash was reported by 72 percent of patients who received Tarceva plus gemcitabine and by 28 percent of patients who received gemcitabine plus placebo. Diarrhea was reported by 51 percent of patients who received Tarceva plus gemcitabine and by 36 percent of patients who received gemcitabine plus placebo.