The US drug regulator, the Food and Drug Administration (FDA), has suspended testing of an experimental cancer drug by Mersana Therapeutics following the death of a clinical trial participant. The FDA’s decision was confirmed by the pharmaceutical company on Monday (3/13).
The study, still in its early stages, tested XMT-2056, a candidate for Mersana immunotherapy. According to the US company, the serious adverse event occurred with the second volunteer enrolled in phase 1 of the clinical trial, carried out in previously treated patients with recurrent solid tumors or HER2+ metastases. He was at the starting dose level, which would be escalated as treatment progressed.
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The cause of death, classified as a serious adverse event, is under investigation. For now, no patient will be enrolled in the study or receive the drug.
“In line with our firm commitment to patient safety, we have been proactive in our response to this event. With clinical maintenance in place, our efforts for XMT-2056 are now focused on fully analyzing this serious adverse event and considering possible next steps for drug development,” says Mersana Therapeutics President and CEO Anna Protopapas in a statement posted on the company’s website.
Anna reported that Mersana will continue to test other cancer therapies, including UpRi and XMT-1660.
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