Roche, Genentech and OSI Pharmaceuticals today announced positive results from a phase III study of investigational drug Tarceva (erlotinib) in locally advanced or metastatic pancreatic cancer patients.
The study met its primary endpoint of improving overall survival.
This study demonstrated a statistically significant 23.5 percent improvement in overall survival for patients with locally advanced or metastatic pancreatic cancer receiving Tarceva plus gemcitabine, when compared to patients receiving gemcitabine alone (a hazard ratio of 0.81 and a p-value of 0.025 were observed). A statistically significant improvement in progression-free survival was also demonstrated although no differences in tumor response were observed.
Pancreatic cancer is the fourth leading cause of all cancer deaths; in Europe each year, 60,000 people are diagnosed with pancreatic cancer, and current treatment options are limited.
“The survival benefit delivered in this study is particularly exciting, as these results come on top of the good data in lung cancer. This means new hope for pancreatic patients who currently have a poor prognosis and further encourages us that Tarceva may have significant potential in a number of cancers,” said William M. Burns, head of Roche’s Pharmaceuticals Division.
“This study reaffirms Tarceva’s position as the fifth product in our oncology portfolio with a proven survival benefit alongside Herceptin, MabThera, Xeloda and Avastin, underlining Roche’s leadership in oncology,” he said.
“The results of this trial of Tarceva in combination with gemcitabine represent an important advancement in treating patients with pancreatic cancer,” stated Dr. Malcolm Moore, 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 signalling pathway is an important target in pancreatic cancer, and offer hope that further progress can be made.”
In a recent study, Tarceva was shown to significantly improve survival in nonsmall cell lung cancer (NSCLC), the most common type of cancer worldwide.
A Marketing Authorization Application for Tarceva monotherapy treatment of advanced nonsmall cell lung cancer was recently made to the European health authorities and to the U.S. Food and Drug Administration (FDA).
Early stage trials of Tarceva are also being conducted in other solid tumors, such as ovarian, colorectal, head and neck, renal cell carcinoma, glioma and gastrointestinal cancers.
The multi-center, randomized, double-blind, placebo-controlled Phase III international study was conducted by the National Cancer Institute of Canada, Clinical Trials Group at Queens University (NCIC CTG) in collaboration with OSI Pharmaceuticals.
The study evaluated Tarceva at 100mg/day or 150mg/day in patients with locally advanced or metastatic pancreatic cancer. Patients received either gemcitabine with Tarceva or gemcitabine plus placebo.
A total of 569 patients were randomized into the study, with 521 patients receiving 100mg/day Tarceva or placebo and 48 patients receiving 150mg/day Tarceva or placebo.
The study was an international study with sites in the U.S., Asia, Canada, Europe, Australia and South America.
This international study demonstrated a statistically significant 23.5 percent improvement in overall survival for patients with locally advanced or metastatic pancreatic cancer when compared with overall survival in 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).
A statistically significant improvement in progression-free survival was also demonstrated although no differences in tumor response were observed.
A preliminary analysis of the safety data did not reveal any unexpected safety signal beyond that seen in prior experience of Tarceva use in both monotherapy and combination settings.
Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in many cancers.
HER1, also known as EGFR, is a key component of the HER signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth.
Metabolized Sugar, Fat
Previous studies have shown that Tarceva is the first agent to show a survival benefit in patients with relapsed nonsmall cell lung cancer, resulting in Roche’s recent submission of a Marketing Authorization Application to the European health authorities for Tarceva for the monotherapy treatment of advanced nonsmall cell lung cancer. A similar application for Tarceva has also been made to the U.S. Food and Drug Administration.
The pancreas is a large organ lying behind the stomach that is essential in the metabolism of sugar and fat. Cancer of the pancreas strikes about five out of every 100,000 people and is one of the deadliest forms of cancer.
Approximately 60,000 new cases of pancreatic cancer are diagnosed per year in Europe and 30,000 new cases in the U.S. The prognosis is poor for pancreatic cancer patients, with most studies showing five-year survival of less than 5 percent.
Those at the highest risk are in their 60s to 80s. Most pancreatic tumors originate in the cells of the pancreas that produce digestive enzymes (acinar cells). These adenocarcinomas account for almost 95 percent of pancreatic tumors.
Within the last five years the Roche Group, including its partners Genentech in the U.S. and Chugai in Japan, has become the world’s leading provider of anticancer treatments, supportive care products and diagnostics.