ATLANTIS phase III study evaluating lurbinectedin (Zepzelca) in combination with doxorubicin for patients with small cell lung cancer fails to meet primary outcome

Study comparing this alkylating drug in combination with doxorubicin against physician's choice of topotecan or cyclophosphamide/doxorubicin/vincristine did not meet pre-specified criteria of significance for primary endpoint of overall survival in intent-to-treat population.

SPS commentary:

The FDA approved lurbinectedin under accelerated approval in June 2020 for the treatment of adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. The approval was based on overall response rate and duration of response demonstrated in an open-label, monotherapy clinical study. The companies will provide the ATLANTIS data to FDA to determine the confirmatory data that is needed for full approval.

Biospace Inc.