Celgene has announced the presentation of final results from two company-sponsored studies of Amrubicin in relapsed small cell lung cancer (SCLC) at the 13th World Conference on Lung Cancer in San Francisco, Calif.
Amrubicin is an anthracyline-like molecule with potent topoisomerase II inhibition and represents the first solid tumor-focused compound to complete phase II studies for Celgene.
The first study compared Amrubicin to topotecan, a common and approved treatment for SCLC, in patients with extensive-disease SCLC who were sensitive to first-line platinum-based chemotherapy.
The study demonstrated that the overall response rate (ORR) was significantly higher in patients treated with Amrubicin (44.0%) compared to patients treated with topotecan (11.5%) (p=0.005), meeting the primary endpoint of the study (to demonstrate an Amrubicin ORR of = 25%). In addition, the complete response rate was 12% for the Amrubicin arm compared to 4% for the topotecan arm. Of note, for patients aged 65 years or older, the ORR for patients receiving Amrubicin was 46% compared to 7% for patients receiving topotecan.