>>MELVILLE, N.Y. & SOUTH SAN FRANCISCO, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Sept. 20, 2004--OSI Pharmaceuticals, Inc. (Nasdaq:OSIP - News), Genentech, Inc. (NYSE: DNA - News), and Roche (SWX Zurich) announced today that results from a randomized Phase III clinical study of the investigational drug Tarceva(TM) (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(TM) 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(TM) in both monotherapy and combination settings. As expected, rash and diarrhea were the principal Tarceva(TM) related side effects seen in the study.
Tarceva(TM) 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(TM) 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."
"The positive outcome of this study is great news for pancreatic cancer patients and their families and adds to our growing understanding of the broad potential utility of Tarceva," said Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "The results represent an important demonstration of Tarceva's activity beyond non-small cell lung cancer, and building on the results of our monotherapy studies in lung cancer, will support our ongoing efforts to further optimize the dosing and scheduling of Tarceva for the treatment of both pancreatic cancer and other cancers."
"These data are important in that they open the door to a completely new approach in the treatment of pancreatic cancer, a disease in which currently only 20 percent of patients survive one year after diagnosis," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. "We will work closely with our collaborators to continue to understand these data, as well as determine additional clinical studies to optimize the potential use of Tarceva in this disease setting. The alliance will discuss these data with the FDA and other regulatory agencies to determine the next steps for Tarceva in pancreatic cancer."
In July 2004, OSI completed the submission of a New Drug Application (NDA) with the FDA for Tarceva(TM), as a monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one standard chemotherapy regimen.
About the Study
This was a multi-center, randomized, double-blind, placebo-controlled Phase III study evaluating Tarceva(TM) at 100 mg/day or 150 mg/day in patients with locally advanced or metastatic pancreatic cancer. The study randomized patients to receive either gemcitabine plus concurrent Tarceva(TM) or gemcitabine plus placebo. A total of 569 patients were randomized in the study, 521 patients in the group who received 100 mg/day of Tarceva(TM) or placebo, and 48 patients in the group who received 150 mg/day of Tarceva(TM) or placebo. The study was an international study with sites in the United States, Asia, Canada, Europe, Australia and South America.
About Pancreatic Cancer
According to the World Health Organization more than 216,000 people worldwide are diagnosed each year with pancreatic cancer. The American Cancer Society predicts that in 2004 about 31,860 people in the United States will be found to have pancreatic cancer and about 31,270 will die of the disease. Most pancreatic tumors originate in the exocrine duct cells or in the cells that produce digestive enzymes (acinar cells). Called adenocarcinomas, these tumors account for nearly 95 percent of pancreatic cancers.
About Tarceva(TM)
Tarceva(TM) is designed to block tumor cell growth by inhibiting the tyrosine kinase activity of the HER1/EGFR receptor thereby blocking the HER1/EGFR signaling pathway inside the cell. Tarceva(TM) is currently being evaluated in an extensive clinical development program by a global alliance among OSI Pharmaceuticals, Genentech, and Roche.
In April 2004, the alliance announced that Tarceva(TM) extended survival of patients receiving monotherapy Tarceva(TM) in a large randomized Phase III study in patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one standard chemotherapy regimen. Tarceva(TM) is the first and only targeted therapy to demonstrate an improvement in survival for advanced NSCLC patients. Detailed results of the trial were presented in June at the 40th Annual American Society of Clinical Oncology (ASCO) meeting in New Orleans.
The NDA was granted Pilot 1 Status under the FDA's Pilot 1 Program for Continuous Marketing Applications, a new program designed for investigational products that have been given Fast Track status such as Tarceva(TM), and that have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for a disease or condition. In addition, Roche recently submitted a marketing Authorization Application to the European health authorities for Tarceva(TM) for the monotherapy treatment of advanced NSCLC.<<
snip
Cheers, Tuck |
