Ipilimumab in the common daily practice: Feasibility, safety, and efficacy in heavily pretreated metastatic melanoma patients

Abstract

e20002 Background: Effective anti-tumor responses are being observed in metastatic melanoma (MM) patients (pts) with the anti-CTLA-4 antibody Ipilimumab (Ipi) in clinical trials; however no data support the feasibility and clinical effectiveness of Ipi use in the daily practice. We report a single Institution experience utilizing Ipi within a compassionate program for MM pts. Methods: 27 stage III (2) or IV (25) pts (14 males, 13 females), median age 55 (23–77) years, ECOG performance status 0- 1, with MM (23 cutaneous, 3 uveal, 1 mucosal) progressing to 3 median (1–5) systemic therapies for metastatic disease received Ipi. Eight pts had evidence (6) or history (2) of brain metastases and 11 elevated (>1x upper limit of normal [ULN]) LDH. In the induction phase (IF) pts received Ipi (10 mg/kg i.v.) q3 weeks (wks) x 4 cycles; after a 12 wks rest treatment was repeated q12 wks in the maintenance phase (MF). Tumor assessment (TA) per modified World Health Organization criteria was performed at baseline, week (wk) 12 (±2) and wk 24, then every 12 wks. Adverse Events (AE) and immune related AE (irAE) were collected according to Common Terminology Criteria for Adverse Events version 3.0. Results: All pts received at least one Ipi dose, and 18/27 completed the IF. Of the remaining 9 pts, 4 are completing the IF and 5 were withdrawn for AE severity (3 pts) or disease progression (2 pts). Eight pts entered the MF. TA at wk 12 showed partial response (PR) in 1/18 or stable disease (SD) in 5/18 pts. TA at wk 24 showed PR and SD in 3/8 and 5/8 pts, respectively, with an ongoing clinical benefit (SD + PR + CR) of 34% (8/23 pts); these pts are still on treatment. Slow, steady declines in tumor volume and appearance of new lesions with subsequent shrinking of total tumor burden has been observed. One patient had Grade 3 AE (myocardial infarction) and 2 pts had Grade 3 irAE (diarrhoea). Excluding pts who are in IF, to date median overall survival is 27 wks (19–39). Conclusions: Ipi treatment is feasible, safe and clinically effective also in the common daily practice and in heavily pretreated, progressing, MM pts. A sizable proportion of these pts experiences durable clinical benefit. No significant financial relationships to disclose.