Pembrolizumab in relapsed or refractory Hodgkin lymphoma: Two-year follow-up of KEYNOTE-087.

Abstract

Programmed death 1 inhibitors are recommended for patients with relapsed or refractory classic Hodgkin lymphoma (RRcHL). However, durability of response remains to be determined. We present 2-year follow-up of the phase 2 KEYNOTE-087 (NCT02453594) study of pembrolizumab in 210 patients in 3 cohorts based on HL progression With median follow-up of 27.6 months, objective response rate (ORR) by blinded independent central review was 71.9% (95% CI, 65.3-77.9); complete response rate (CRR), 27.6%; partial response rate, 44.3%. Response rates by cohort were as follows: cohort 1: ORR: 76.8%; CRR: 26.1%; cohort 2: ORR: 66.7%; CRR: 25.9%; cohort 3: ORR: 73.3%; CRR: 31.7%. Median duration of response was 16.5 months (range, 0.0+ to 27.0+; [+, no progressive disease at last assessment]) in all patients; 22.1 months in cohort 1, 11.1 months in cohort 2, and 24.4 months in cohort 3. Median progression-free survival was not reached in all patients with CR, 13.8 months (95% CI, 12.0-22.1) for patients with partial response, 10.9 months (95% CI, 5.6-11.1) for patients with stable disease. Median overall survival was not reached in all patients or in any cohort. Treatment-related adverse events (TRAEs) of any grade occurred in 153 (72.9%) patients; grade 3/4 occurred in 25 (11.9%) patients, most commonly, neutropenia (5 [2.4%]) and diarrhea (3 [1.4%]); none resulted in death. TRAEs led to discontinuation in 14 (6.7%) patients. Results confirmed the effective antitumor activity, durability of response, and manageable safety of pembrolizumab monotherapy in RRcHL, regardless of prior treatment and including chemoresistant cHL.