The randomized phase III clinical study of Tarceva (erlotinib) plus gemcitabine chemotherapy in patients with locally advanced or metastatic pancreatic cancer, met its primary endpoint by demonstrating a statistically significant 23.5% improvement in overall survival when compared to patients receiving gemcitabine plus placebo.
Tarceva 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.
Furthermore, 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.
“These Tarceva results represent an important medical advance in the treatment of patients with pancreatic cancer and we hope will open the door to a completely new approach to treating the disease,” said Dr Malcolm Moore, study chair and medical oncologist at Princess Margaret Hospital in Toronto, Canada and chair of the gastrointestinal disease site, NCIC Clinical Trials Group.
With these new results, Tarceva has now shown a survival benefit in two difficult-to-treat cancers, namely pancreatic and lung cancer.