FDA lifts hold on Mersana cancer trial

Sept. 17, 2018

Mersana Therapeutics announced that the U.S. FDA has lifted a partial clinical hold on its phase I trial of its cancer treatment, XMT-1522.

A partial hold was imposed in July after a patient enrolled in the trial died. Under the hold, no new patients were enrolled in the trial — which is testing the drug in individuals with breast, gastric and non-small cell lung cancers -- but the trial continued on for patients who were already participating.

The Massachusetts-based clinical-stage biopharmaceutical company said they reached alignment with the FDA on changes to the protocol, including increased monitoring as well as the exclusion of patients with advanced hepatic impairment.

“We are excited to resume enrollment on the XMT-1522 trial and to work with investigators to explore the full potential of both promising drug candidates in the solid tumor setting,” said Anna Protopapas, Chief Executive Officer of Mersana.

Read the press release