Abstract
2534 Background: After chemotherapy failure, treatment options for advanced cervical cancer are limited. EGFR is expressed by 80–100% of cervical cancers, suggesting that inhibiting EGFR signaling may be beneficial. Matuzumab is a humanized IgG1 monoclonal anti-EGFR antibody with single-agent clinical activity. This study assessed the response rate to matuzumab in subjects with cervical cancer progressing after treatment with platinum-based chemotherapy. Methods: Subjects received matuzumab (800 mg) weekly for 6 months in 4-week cycles. Antitumor activity (RECIST criteria) was assessed by CT/MRI at screening and every 8 weeks. PK sampling was performed at days 1, 3, 5, 8, 15, 22, and 29, and at end of treatment. EGFR saturation and percentage of pEGFR and pMAPK were determined in biopsies (skin, tumor, vaginal tissue) at screening and after the 1st cycle. Safety and tolerability were monitored after each infusion and with weekly haematological assays and monthly laboratory assessments. Results: All subjects had prior chemotherapy; 39/41 prior radiotherapy. Tumors were 29 squamous cell, 11 adenocarcinomas, and 1 undifferentiated carcinoma, stages IVB (n=7), IIIB (n=8), IIIA (n=1), IIA-B (n=12) and IB (n=10) (3 missing). Median age was 44 (range 26–73) years. Subjects received a median of 8 matuzumab infusions (range 1–57). Among 38 evaluated subjects, best responses in the preliminary analysis were 2 PR and 9 SD (independent assessment pending). Matuzumab-related grade (gr) 3 adverse events included elevated γ-GT (1), hepatotoxicity (1), diarrhea (1), fainting and thrombocytopenia (1), anorexia and lethargy (1), abdominal pain (1), and skin peeling/dryness (1). One subject with gr 4 abdominal pain and blood amylase with gr 3 pancreatitis discontinued treatment. PK and biological marker evaluations will be presented. Conclusions: Based on preliminary observations, the level of activity in this phase II study merits further investigation of matuzumab after platinum-based chemotherapy in subjects with advanced cervical cancer. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Merck Merck, Merck KGaA Merck, Merck KGaA Merck, Merck KGaA
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