FDA lifts clinical hold on Mersana’s STING agonist, PhI starting dose lowered after patient death

The FDA has lift­ed the full clin­i­cal hold on Mer­sana Ther­a­peu­tics’ STING-tar­get­ed an­ti­body-drug con­ju­gate on the back of the com­pa­ny mak­ing Phase I study dos­ing al­ter­ations af­ter a pa­tient death.

The FDA placed the hold on the tri­al in HER2-pos­i­tive re­cur­rent or metasta­t­ic sol­id tu­mors back in March. The de­ci­sion came af­ter Mer­sana told the agency it would vol­un­tar­i­ly sus­pend the tri­al be­cause of a pa­tient death that was deemed re­lat­ed to the ADC as­set XMT-2056. The death oc­curred in the sec­ond pa­tient en­rolled at the ini­tial dose lev­el in the study; no pa­tients have been treat­ed or en­rolled since.

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