Abstract
9023 Background: A phase II, open-label, single-arm study was conducted to assess antitumor activity of tremelimumab (CP- 675,206), a fully human, anticytotoxic T lymphocyte-associated antigen 4 monoclonal antibody, in patients with advanced melanoma. Methods: Patients with measurable surgically incurable stage III or IV melanoma who had progressed, relapsed, or could not tolerate previous treatment received 15 mg/kg tremelimumab administered IV every 12 weeks for up to 4 cycles or until progression of disease or intolerable toxicity. Patients with clinical benefit were eligible for ≤ 4 additional doses. The primary study endpoint was proportion of confirmed objective RECIST responses per independent review, and secondary endpoints included safety, duration of response, and overall survival (OS). Results: Of 251 patients enrolled, 246 patients (241 response-evaluable) received a median of 1 dose (range, 1 to 7). Preliminary RECIST objective response rate was 8.3% (20 PRs, of which 5 are pending independent confirmation). In addition, 13/15 (86.7%) confirmed PRs are ongoing (4.0+ to 11.1+ months). The majority of PRs involved target lesions in lung, lymph nodes, and/or liver. Clinical benefit rate was 22.8% (PRs + SDs ≥ 70 days since first dose). In addition, 7 patients (2.9%) with mixed responses (ie, best overall response of PD but PR in target lesion) remain alive on study with censored OS (9.7+ to 13.5+ months). Median OS was 10.0 months. The majority of drug-related adverse events (AEs) were mild to moderate, and grade 3/4 AEs were primarily diarrhea (n=28, 11.4%), fatigue (n=6, 2.4%), and colitis (n=5, 2.0%). There were 2 (0.8%) treatment-related deaths (1 sudden death and 1 diverticular perforation). Conclusions: This study does not demonstrate a second-line response rate exceeding 10% but the duration of response of this regimen suggests a role for tremelimumab in this population. A full assessment of clinical benefit will await survival data from this study and the ongoing, randomized phase III first-line study. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Pfizer Pfizer Pfizer Pfizer Pfizer Pfizer
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