Phase 2 trial of erlotinib with or without PF-3512676 (CPG 7909, a Toll-like receptor 9 agonist) in patients with advanced recurrent EGFR-positive non-small cell lung cancer

Abstract

This phase 2 study assessed PF-3512676 plus erlotinib in patients with epidermal growth factor receptor-positive advanced non-small cell lung cancer after prior chemotherapy failure. Patients were randomized 1:1 to PF-3512676 (0.20 mg/kg injected subcutaneously once weekly) plus erlotinib (150 mg daily) or erlotinib alone. The primary objective was to estimate progression-free survival (PFS). Patients received PF-3512676 plus erlotinib (n = 18) or erlotinib alone (n = 21). The study was halted because an unplanned interim analysis indicated that large improvement in PFS with addition of PF-3512676 would be unlikely. In the PF-3512676-plus-erlotinib and erlotinib-alone arms, median PFS was 1.6 and 1.7 mo (hazard ratio, 1.00; 95% confidence interval, 0.5–2.0; P = 0.9335), respectively. Salient grade ≥ 3 adverse events in PF-3512676-plus-erlotinib and erlotinib-alone arms were diarrhea (5/0), dyspnea (5/6), fatigue (4/1), other flu-like symptoms (2/0), anemia (2/1), and lymphocytopenia (based on laboratory values, 1/4). Adding PF-3512676 to erlotinib did not show potential for increased progression-free survival over erlotinib alone in patients with advanced recurrent epidermal growth factor receptor-positive non-small cell lung cancer.

Keywords: :

• carcinoma
• EGFR
• epidermal growth factor
• erlotinib
• non-small cell lung cancer
• PF-3512676
• receptor
• Toll-like receptor 9

Disclosure of Potential Conflicts of Interest

SJM is employed by Pfizer Inc.; RJB and CBM are Pfizer Inc. employees and stockholders; JJN is the Chief Medical Officer of and holds stock in Gradalis, Inc.; AC has received speakers bureau honoraria from Eli Lilly and Genentech; LER has been a consultant/advisor and received speakers bureau honoraria from Genentech and OSI and has received research grants/support from Pfizer and Genentech; PDE has received research grants/support from Pfizer and Genentech. All remaining authors have declared no conflicts of interest.

Acknowledgments

This study (NCT00321815) was sponsored by Pfizer Inc. Medical editorial support was provided by Tamara Fink, PhD, of Accuverus Inc., a division of ProEd Communications, Inc.^® and was funded by Pfizer Inc.