Efficacy and safety of checkpoint blockade for treatment of advanced melanoma (mel) in patients (pts) age 80 and older (80+).

Abstract

10009 Background: Little is known about the use of checkpoint blockade in pts aged 80+. Here we report the efficacy and safety of these agents in this pt population. Methods: We identified mel pts at MSKCC aged 80+ who received at least 1 dose of ipilimumab (ipi), pembrolizumab or nivolumab (anti-PD1) or the combination of ipi+nivo and had a least 1 follow-up visit. 7 pts received anti-PD1 after ipi at MSKCC. Adverse events (AEs) graded using CTCAE v4.0 were collected. Pts who received anti-PD1 were grouped. Pts who received ipi and then anti-PD1 at MSKCC had AEs collected for both drugs but were included in the ipi survival analysis. Results: The rate of AEs was similar across groups, but the rate of grade ≥ 3 events was higher in the ipi+nivo group. There were no treatment-related deaths. 5/74 (6.8%) ipi pts, 0/24 anti-PD1 pts and 3/8 (37.5%) ipi+nivo pts required infliximab for diarrhea. An asymptomatic increase in lipase was seen in 4/8 (50%) ipi+nivo pts and 2/24 (8.3%) of anti-PD1 pts. Fatigue occurred in 4/8 (50%) of ipi+nivo pts and 6/24 (25%) of anti-PD1 pts. In the anti-PD1 group, there was one case each of grade 4 anemia and nausea/vomiting. Median overall survival (OS) was 7.5 months (95% CI: 6.0, 13.7) in the ipi pts, 14.2 months (95% CI: 5.3, not reached (NR)) in the anti-PD1 pts and 23.5 months (95% CI: 1.5, NR) in the ipi+nivo pts. Conclusions: The rate of AEs in pts aged 80+ is comparable to published phase III data in all age groups. PD-1 inhibitors and ipi+nivo prolong survival compared to ipi alone in this age group. Further study of these agents in this age group is needed. Ipi (N = 74) Anti-PD1 (N = 24) Nivo+Ipi (N = 8) Age - yr Mean, range 84, (80-93) 86, (80-94) 82, (80-87) Sex -no. (%) Male 55(74.3) 16(66.7) 2 (25) Female 19(25.7) 8 (33.3) 6 (75) Toxicity Any Grade Grade 3 or 4 Any Grade Grade 3 or 4 Any Grade Grade 3 or 4 All AEs 65(87.8) 22(29.7) 21(87.5) 5(20.8) 7(87.5) 5(62.5) Diarrhea 32(43.2) 13(17.6) 2(8.3) 1(4.2) 5(62.5) 2(25) Transaminitis 41(55.4) 10(13.5) 0(0) 0(0) 6(75) 2(25) Pruritus 0(0) 0(0) 7(29.2) 0(0) 3(37.5) 0(0) Rash 28(37.8) 4(5.4) 8(33.3) 0(0) 5(62.5) 1(12.5) Pneumonitis 0(0) 0(0) 2(8.3) 0(0) 2(25) 0(0) Arthralgia/Myalgia 0(0) 0(0) 4(16.7) 0(0) 1(12.5) 0(0) Hypophysitis 4(5.4) 2(2.7) 0(0) 0(0) 0(0) 0(0)