POTP to Conduct Unscheduled Interim Analysis in NSCLC Trial
[Normally, when things are going well, you don’t rock the boat; hence, this PR has a whiff of bearishness to it. But clearly the market doesn’t see it that way because the shares were up 33% today. POTP’s shares were hammered in March when a Talabostat trial in pancreatic cancer failed.]
>> Point Therapeutics Announces Interim Analysis to be Performed on Its Phase 3 Talabostat with Alimta Study
Tuesday May 15, 10:02 am ET
BOSTON--(BUSINESS WIRE)-- Point Therapeutics, Inc. (NASDAQ: POTP ) today announced that the Company's Board of Directors approved an unscheduled interim analysis on the Phase 3 non-small cell lung cancer (NSCLC) study of talabostat in combination with pemetrexed (Alimta®: Eli Lilly). The study was designed to enroll 400 NSCLC patients who have already failed either one or two prior drug regimens. To date, approximately 360 patients have enrolled in the study. The interim analysis will examine approximately 150 events that have already been recorded in this study, with events being defined as either disease progression or death. The Company expects results from the interim analysis by the end of this month.
"This analysis will produce the first clinical information on the effects of talabostat in a controlled, randomized trial," said Don Kiepert, President and CEO. "We felt that it was important to have controlled data at this time in order to properly assist us in our on going strategic and business initiatives."
Talabostat's NSCLC program consists of two randomized, placebo-controlled, double-blind Phase 3 studies in the second-line and third-line setting. One of the Phase 3 studies is evaluating talabostat and pemetrexed versus placebo and pemetrexed. In the interim analysis, median progression-free survival (PFS) and overall survival data and the statistical analyses of these data for the talabostat treatment arm will be compared with the control arm by an independent data monitoring committee. The Company expects to report on the committee's recommendation to continue the trial or stop the trial either due to reaching statistical significance (p less than 0.005) or futility. The Company may also perform an unscheduled interim analysis on its Phase 3 study evaluating talabostat in combination with docetaxal (Taxotere® : sanofi-aventis), although a final decision has not been made.
Originally the pemetrexed study was powered at 80% to detect an approximate hazard ratio of 1.4 (p=0.05) in PFS over the placebo arm with a positive trend in overall survival upon final analysis. The addition of the interim analysis has only slightly modified the final statistical plans. The trial remains powered at 80% to demonstrate an approximate hazard ratio of 1.4 in PFS with an adjusted statistical level of p=0.048.
About Point Therapeutics, Inc.:
Point is a Boston-based biopharmaceutical company which is currently studying its lead product candidate, talabostat, in two Phase 3 double blind placebo-controlled trials in metastatic non-small cell lung cancer. Point is also currently studying talabostat in a Phase 2 trial in combination with gemcitabine in Stage IV pancreatic cancer. In addition, Point has studied talabostat in several Phase 2 trials, including as a single-agent in metastatic melanoma, in combination with cisplatin in metastatic melanoma and in combination with rituximab in advanced chronic lymphocytic leukemia. <<
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