The FDA granted breakthrough therapy designation to sacituzumab govitecan-hziy for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after platinum-based chemotherapy

The designation is supported by results from the ES-SCLC cohort of the phase 2 TROPiCS-03 trial, which showed antitumor activity and safety for sacituzumab govitecan in both platinum-resistant and platinum-sensitive ES-SCLC patients

Updated data from TROPiCS-03, showed an overall response rate (ORR) of 41.9%, consisting entirely of confirmed partial responses

The disease control rate was 83.7%, and the clinical benefit rate (CBR) was 48.8%, with a median duration of response (DOR) of 4.7 months, and 48.2% of responders maintaining a response at 6 months

Based on the positive data, a phase 3 trial of sacituzumab govitecan in patients with ES-SCLC is planned for further evaluation