Whoopee. Tarceva adds three whole weeks to your life as a pancreatic cancer patient. While XYOTAX nearly flunked the STELLAR trials, the Phase I and II combo results look really good. Might save CTIC's bacon. Hope so.
>>ORLANDO, Fla., May 14 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) and OSI Pharmaceuticals (Nasdaq: OSIP - News) today presented additional data from a randomized Phase III clinical trial of Tarceva(TM) (erlotinib) in advanced pancreatic cancer. Tarceva is the first drug to significantly improve survival in a Phase III trial when added to gemcitabine chemotherapy in first-line pancreatic cancer compared to gemcitabine alone. These data were presented today at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO).
"These ongoing trials reinforce our belief in the potential application of Tarceva in a variety of cancers," said Gabe Leung, president of (OSI) Oncology at OSI Pharmaceuticals. "Based on these data OSI recently submitted to the FDA a supplemental New Drug Application for Tarceva in pancreatic cancer and will be working closely with the FDA through the review process."
"The improvement in survival demonstrated by Tarceva in second- and third-line non-small cell lung cancer as monotherapy and in first-line pancreatic cancer in combination with gemcitabine, underscores our commitment to explore the use of Tarceva in multiple cancers, with the hope of bringing new treatment options to patients," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer.
Tarceva plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A Phase III trial of the National Cancer Institute of Canada Clinical Trial Group (NCIC-CTG) (Abstract #1 - Saturday, May 14, 2005 4:00 p.m. EDT)
A Phase III randomized study of Tarceva in combination with gemcitabine met its primary endpoint by demonstrating a statistically significant 23.5 percent improvement in overall survival (or a hazard ratio of 0.81, which can also be referred to as a 19 percent reduction in the risk of death), the study's primary efficacy endpoint, when compared to patients receiving gemcitabine plus placebo. The data were presented by Malcolm Moore, M.D., of Princess Margaret Hospital in Toronto, Ontario.
The international study was a multi-center, double-blind, placebo-controlled Phase III trial evaluating Tarceva in patients with locally advanced or metastatic pancreatic cancer. The study randomized 569 patients to receive either gemcitabine plus concurrent Tarceva or gemcitabine plus placebo.
In addition to the improvement in overall survival, 24 percent of patients receiving Tarceva plus gemcitabine were alive after one year compared to 17 percent of patients receiving gemcitabine plus placebo, a 41 percent increase in one-year survival. Median survival in the Tarceva plus gemcitabine arm was 6.4 months compared to 5.9 months in the gemcitabine plus placebo arm. Progression-free survival in the Tarceva plus gemcitabine arm was also significantly improved by 32 percent (or a hazard ratio of 0.76, which can also be referred to as a 24 percent reduction in the risk of progression). 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.)
There were no significant differences in overall survival for patients whose tumors were shown to be EGFR-positive (hazard ratio = 0.74, n = 86) versus those whose tumors were shown to be EGFR-negative (hazard ratio = 0.82, n = 76).
The analysis of safety data did not reveal any unexpected safety signals beyond those seen in previous studies of Tarceva in both monotherapy and combination settings. An increase in mild-to-moderate (i.e. Grade 1 and 2) adverse events including rash, diarrhea and hematological toxicity were seen in the Tarceva plus gemcitabine arm. Rash was reported for 72 percent of patients who received Tarceva plus gemcitabine and for 29 percent of patients who received gemcitabine plus placebo. Diarrhea was reported by 56 percent of patients who received Tarceva plus gemcitabine and by 41 percent of patients who received gemcitabine plus placebo. Grade 3/4 rash in the Tarceva plus gemcitabine arm was 6 percent compared to 1 percent in the gemcitabine plus placebo arm. Other Grade 3/4 adverse events were similar in both arms, and rates for the events in the Tarceva plus gemcitabine arm were infection (17 percent), fatigue (15 percent), diarrhea (6 percent), dehydration (3 percent) and pneumonitis (2 percent).<<
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Cheers, Tuck |
