After Phase III miss, PharmaMar and Jazz may need new monotherapy trial to confirm cancer drug’s benefit

PharmaMar will likely need to conduct a new study of Zepzelca to gain its full approval after the drug failed to show a survival benefit in a potentially confirmatory Phase III trial to treat small cell lung cancer. 

Jazz Pharmaceuticals plc (NASDAQ:JAZZ), which has U.S. rights to Zepzelca lurbinectedin, said Thursday that therapy missed the primary endpoint of overall survival in the Phase III ATLANTIS trial in patients with small cell lung cancer (SCLC). ATLANTIS evaluated the drug in combination with doxorubicin vs. physician’s choice of topotecan or cyclophosphamide/doxorubicin/vincristine (CAV). Zepzelca is a DNA transcription inhibitor targeting Pol II in its active state...