OSI Pharmaceuticals, Inc., Genentech, Inc., and Roche announced today that results from a randomized Phase III clinical study of the investigational drug Tarceva (erlotinib HCl), in combination with gemcitabine chemotherapy met its primary endpoint of improving survival.
The international study demonstrated a statistically significant 23.5 percent improvement in overall survival for patients with locally advanced or metastatic pancreatic cancer when compared to patients receiving gemcitabine plus placebo. A hazard ratio of 0.81 and a p-value of 0.025 were observed (a hazard ratio of less than one indicates a reduction in the risk of death and a p-value of less than 0.05 indicates statistical significance). Median and one-year survival in the Tarceva plus gemcitabine arm were 6.4 months and 25.6 percent respectively compared to 5.9 months and 19.7 percent in the gemcitabine plus placebo arm. A statistically significant improvement in progression-free survival was also demonstrated, although no difference in tumor response was observed. A preliminary analysis of the safety data did not reveal any unexpected safety signal beyond that seen in prior use of Tarceva in both monotherapy and combination settings. As expected, rash and diarrhea were the principal Tarceva related side effects seen in the study.
Tarceva is a small molecule oral therapy designed to inhibit the tyrosine kinase activity of the HER1/EGFR signaling pathway inside the cell, which may block tumor growth. This study, which was sponsored by OSI, was coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University. Results from the study will be submitted for presentation at an appropriate peer-reviewed oncology meeting in the near future.
"The results of this trial of Tarceva in combination with gemcitabine represent an important advancement in treating patients with pancreatic cancer," stated Malcolm Moore, M.D., Study Chair and Medical Oncologist at Princess Margaret Hospital and Chair of the Gastrointestinal Disease Site, NCIC Clinical Trials Group. "Pancreatic cancer is widely recognized as a difficult disease to treat and new therapeutic regimens are desperately needed. These results also demonstrate that the HER1/EGFR signaling pathway is an important target in pancreatic cancer, and offer hope that further progress can be made."