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news.NewLink Genetics has announced that the independent data safety monitoring committee (DSMC), following the first of two planned interim data analyses, recommended that the Phase III IMPRESS pancreatic cancer clinical trial with Algenpantucel-L should proceed as planned without modification.
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The DSMC met to review available patient data as part of the planned interim analysis, scheduled to occur following 222 patient events. The DSMC, following its review, recommended that the study should proceed as planned, without modification.
A second interim analysis is planned upon reaching 333 patient events and, if needed, a final analysis is planned at 444 patient events.
NewLink Genetics president and chief medical officer Dr Nicholas N. Vahanian noted in any case, it is reassuring that no unexpected safety issues or other concerns were raised by the independent data safety monitoring committee.
"Now, with the first interim analysis behind us, we look forward to continuing the study and to gathering additional, more mature data in support of our mission to provide improved treatment options for patients with pancreatic cancer," Dr Vahanian added.