ABX-EGF in combination with paclitaxel and carboplatin for advanced non-small cell lung cancer (NSCLC)

Abstract

7083 Background: ABX-EGF is a high-affinity, fully human, IgG2 monoclonal antibody directed against epidermal growth factor receptor (EGFr). This is a report of results from part 1 of a 2-part, phase 2 trial to evaluate the efficacy, safety, and pharmacokinetics (PK) of ABX-EGF in combination with paclitaxel and carboplatin for advanced NSCLC. Methods: In this open-label, sequential, dose-escalation design in pts with NSCLC (stage IIIb or IV) and EGFr expression of 2+ or 3+ in >=10% of tumor cells, pts received weekly IV ABX-EGF in combination with standard paclitaxel and carboplatin every 3 weeks for up to 6 cycles; pts with response or stable disease could receive extended ABX-EGF therapy. Responses (RECIST) were evaluated at week 6 with confirmation >=3 weeks later. The PK of ABX-EGF and paclitaxel were evaluated at weeks 0 and 3. Results: Nineteen pts (5 men/14 women; mean [SD] age 52.2 [11.9] years) were enrolled into 3 ABX-EGF cohorts: 1.0 mg/kg (n=6), 2.0 mg/kg (n=7), and 2.5 mg/kg (n=6). One pt (5%) had a confirmed complete response (1.0 mg/kg) and 4 pts (21%) had partial responses (2 at 2.0 mg/kg and 2 at 2.5 mg/kg) by investigator assessment. The most common adverse event (AE) was skin rash (89% overall; 83%, 100%, and 83% in the 1.0, 2.0, and 2.5 mg/kg groups). The incidence of grade 3 skin rash did not appear to increase with dose (17% at 1.0 mg/kg, 29% at 2.0 mg/kg, and 0% at 2.5 mg/kg). Four pts (1 at 1.0 mg/kg and 3 at 2.0 mg/kg) had ABX-EGF dosing interrupted or reduced because of skin toxicities. The PK of ABX-EGF appeared to be dose dependent. PK results for paclitaxel were similar to that reported in the literature. Conclusions: ABX-EGF is well tolerated in combination with paclitaxel and carboplatin for advanced NSCLC. Part 2 of the study continues to accrue patients to further assess clinical activity in this setting. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen, Inc. Amgen Amgen Amgen Amgen