PP01.50 EMERGE-201: Phase 2 Basket Study of Lurbinectedin Monotherapy in Advanced or Metastatic Solid Tumors

Lurbinectedin (Zepzelca®), a selective inhibitor of oncogenic transcription, received accelerated approval from the US Food and Drug Administration on June 15, 2020, as monotherapy (3.2 mg/m2 by 1-hour IV infusion every 3 weeks) for the treatment of adults with metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was based on overall response rate (ORR; 35.2%) and median duration of response (5.3 months) in a phase 2 study. In addition to SCLC, antitumor activity with lurbinectedin as monotherapy or in combination with additional therapeutic agents has been observed in other advanced solid tumors. The EMERGE-201 study will evaluate the efficacy and safety of lurbinectedin monotherapy in adults with advanced (metastatic and/or unresectable) large-cell neuroendocrine tumor (LCNET) of the lung, as well as in other advanced (metastatic and/or unresectable) solid tumors with high unmet medical needs, including urothelial cancer (UC) and homologous recombination–deficient (HRD) tumor-agnostic malignancies.