WOW, 50% was SECOND LINE treatment. No wander they have ITT survival benefit. When was PLACEBO SECOND LINE options?
<< Patients receiving Tarceva(TM) had a median survival of 6.7 months compared to 4.7 months in patients who received placebo (a 42.5 percent improvement). A hazard ratio of 0.72 and a p-value of 0.001 were determined for comparisons of overall survival (a hazard ratio (HR) of less than one indicates a reduction in the risk of death and a p-value of less than 0.05 indicates statistical significance). In addition, 31 percent of patients receiving Tarceva(TM) in the study were alive at one year versus 22 percent in the placebo arm (a 41 percent improvement). Statistically significant improvements in time to symptom deterioration were observed for key lung cancer symptoms of cough, pain, and dyspnea. The objective response rate in patients treated with Tarceva(TM) was 9 percent versus less than 1 percent in the placebo arm. >>
So, WHY was analysis delayed two times, by at least 6 months? I would like to see KM curve. This was trials with +80% patients accrual outside NA, and (my projection) +50% from third country. Are this median survival data (few months) applicable to today US practice???
ALL in ALL, I am not convicted that Tarceva is better than Iressa.
Miljenko
Press Release Source: OSI Pharmaceuticals, Inc.
Phase III Study of Tarceva in Relapsed Non-Small Cell Lung Cancer Shows Significant Improvement in Survival
Saturday June 5, 9:01 am ET
Only HER1/EGFR-Inhibitor to Show Survival Benefit in Lung Cancer
NEW ORLEANS--(BUSINESS WIRE)--June 5, 2004-- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP - News), Genentech, Inc. (NYSE: DNA - News), and Roche (SWX Zurich) today announced that the pivotal Phase III trial of Tarceva(TM) (erlotinib HCl) in advanced non-small cell lung cancer (NSCLC) demonstrated a 42.5 percent improvement in median survival and a 41 percent improvement in one-year survival rates compared to placebo. The results were featured in an American Society of Clinical Oncology (ASCO) press briefing during the 40th Annual ASCO meeting in New Orleans, La. More detailed presentations of the data will be made to meeting attendees on Monday, June 7th.
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"Tarceva(TM) is the first and only epidermal growth factor receptor (EGFR) inhibitor and the first targeted non-chemotherapy agent to demonstrate an improvement in overall survival and exhibit symptom related benefits in a large randomized study in lung cancer patients," stated Dr. Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "We believe that the association of these benefits with a favorable safety profile will provide an important potential treatment option for lung cancer patients."
"These results represent an important medical advance in the treatment of advanced lung cancer patients," stated Study Chair, Frances A. Shepherd, M.D., FRCPC, Scott Taylor Chair in Lung Cancer Research at the Princess Margaret Hospital, Professor of Medicine at the University of Toronto. "The outcome of the study is particularly noteworthy considering the broad spectrum of advanced lung cancer patients enrolled in the study. The observations concerning symptoms are also particularly meaningful to these patients."
The study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University, Ontario in collaboration with OSI Pharmaceuticals.
Study Results
This trial of Tarceva(TM) met the pre-determined primary study endpoint of improvement in overall survival and demonstrated significant effects in all secondary endpoints including time to symptom deterioration, progression-free survival and response rate. A total of 731 patients were enrolled in BR.21, a randomized, international, double-blind controlled study comparing the use of 150mg/day Tarceva(TM) versus placebo for the treatment of patients with advanced NSCLC following failure of first or second-line chemotherapy. The study randomized patients with a 2:1 ratio in favor of Tarceva(TM) to receive either Tarceva(TM) or placebo.
Patients receiving Tarceva(TM) had a median survival of 6.7 months compared to 4.7 months in patients who received placebo (a 42.5 percent improvement). A hazard ratio of 0.72 and a p-value of 0.001 were determined for comparisons of overall survival (a hazard ratio (HR) of less than one indicates a reduction in the risk of death and a p-value of less than 0.05 indicates statistical significance). In addition, 31 percent of patients receiving Tarceva(TM) in the study were alive at one year versus 22 percent in the placebo arm (a 41 percent improvement). Statistically significant improvements in time to symptom deterioration were observed for key lung cancer symptoms of cough, pain, and dyspnea. The objective response rate in patients treated with Tarceva(TM) was 9 percent versus less than 1 percent in the placebo arm.
Approximately 50 percent of the patients in the study had previously received one prior regimen while the remainder had received two prior regimens. In addition, the study enrolled a relatively large proportion of patients with poor performance status (PS2: 25% and PS3: 9%). Despite these unfavorable pre-treatment characteristics, treatment benefit was documented in the majority of patients.
"This trial is important because a survival treatment benefit was achieved among a broad group of patients who were not selected for factors such as EGFR status, gender, smoking history or type of non-small cell lung cancer," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. "We are grateful to the hundreds of patients and their families around the world who volunteered for this study and contributed to this landmark research."
OSI will work with the U.S. Food and Drug Administration to complete the New Drug Application (NDA) for Tarceva(TM) during the summer of 2004.
Safety
The safety profile observed for Tarceva(TM) in the study was consistent with observations made in prior Tarceva(TM) studies. Seventy-six percent of patients receiving Tarceva(TM) exhibited rash (versus 17 percent in the placebo group) and 55 percent of patients receiving Tarceva(TM) experienced diarrhea (versus 19 percent for placebo). Most of these were mild or moderate. Dose reductions occurred for rash and diarrhea only in the Tarceva(TM) arm, 12 percent and five percent respectively. In this large placebo-controlled study, severe pulmonary events including potential cases of interstitial lung events were rare and generally equally distributed between treatment arms. |
