JAZZ - Late-stage study of Jazz Pharma's zepzelca + doxorubicin in lung cancer fails to meet primary endpoint

Jazz Pharmaceuticals (JAZZ) along with its partner, PharmaMar announce results from the ATLANTIS Phase 3 study evaluating Zepzelca (lurbinectedin) in combination with doxorubicin versus topotecan or cyclophosphamide/doxorubicin/vincristine ((CAV)) for adult patients with small cell lung cancer ((SCLC)) whose disease progressed following one prior platinum-containing line.Patients received lurbinectedin at 2.0mg/m2 in the combination arm, which is lower than the FDA approved dose of Zepzelca at 3.2mg/m2. The study did not meet the pre-specified criteria of significance for the primary endpoint of overall survival ((OS)) in the intent-to-treat population comparing lurbinectedin in combination with doxorubicin to the control arm, though there was no adverse effect on OS with the experimental arm.Based on the study design, no additional hypotheses were formally tested. Importantly, key secondary and subgroup analyses favored the lurbinectedin combination arm.The secondary endpoints were the difference in OS for patients in the lurbinectedin/doxorubicin arm compared to patients treated with CAV; OS and

For further details see:

Late-stage study of Jazz Pharma's zepzelca + doxorubicin in lung cancer fails to meet primary endpoint