Randomized phase II study of SGN-15 (CBR96-doxorubicin immunoconjugate) with docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC)

Abstract

7039 Background: Docetaxel (Doc) remains the only FDA approved second line chemotherapy for NSCLC, but response rates and survival are low. Targeted therapies may hold more promise. NSCLC cells express a variety of tumor antigens, including the Lewis Y (Ley) antigen. SGN-15 is a novel antibody-drug conjugate that targets Ley, and delivers doxorubicin intracellularly. A multi-center randomized phase II study was conducted to evaluate the safety and efficacy of the combination of SGN-15/Doc as second or third line treatment for patients with advanced NSCLC who have progressed after platinum-based chemotherapy. Methods: In this 2:1 randomized study, 62 patients (pts) were randomly assigned to SGN-15 200 –350 mg/m2 + Doc 35 mg/m2 or Doc alone. A course of therapy was defined as 6 weekly doses within an 8 week period with response evaluation every 8 weeks. Primary endpoint was survival with secondary endpoints including response, toxicity and quality of life, Results: Median overall survival was 7.3 months for...