Pembrolizumab treatment resulted in high overall response rates (ORRs) among patients with relapsed/refractory classic Hodgkin lymphoma (cHL) regardless of previous therapy, according to a study published in the Journal of Clinical Oncology.1
In March 2017, pembrolizumab received accelerated approval for adult and pediatric patients with refractory cHL or disease that relapsed after 3 or more prior therapies.2 The purpose of this phase 2 trial (ClinicalTrials.gov Identifier: NCT02453594) was to evaluate the response to pembrolizumab among patients with differing prior treatments for relapsed/refractory disease.
The KEYNOTE-087 trial treated 210 patients with 200 mg of pembrolizumab every 3 weeks for a median of 13 cycles. The study consisted of 3 cohorts: patients with relapsed/refractory disease treated previously with autologous stem cell transplantation (ASCT) with brentuximab vedotin (BV), ASCT without BV, and salvage chemotherapy with BV.
The median age at baseline was 35 and the Eastern Cooperative Oncology Group performance status was 0 in 49% and 1 in 51% of patients. The median number of previous lines of therapy was 4 and 83% of patients received prior BV.
The ORR of the entire cohort was 69% (95% CI, 62.3-75.2%).
The ORR was similar between treatment cohorts at 73.9% (95% CI, 61.9-83.7%) in the ASCT and BV arm, 64.2% (95% CI, 52.8-74.6%) in the chemotherapy with BV arm, and 70% (95% CI, 56.8-81.2%) in the ASCT only arm, though progressive disease occurred more frequently in the chemotherapy with BV arm.
The median duration of response was not reached among all cohorts and 75.6% of patients demonstrated a response for at least 6 months.
The median overall survival (OS) was also not reached, though an ad hoc analysis estimated the 9-month OS to be 97.5% and a 9-month progression-free survival of 97.5%.
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Immune-related and/or infusion-related adverse events (AEs) occurred in 28.6% of patients. Treatment-related AEs resulted in treatment discontinuation among 4.3% and interruption among 12.4%.
The authors concluded that “pembrolizumab showed excellent results in both relapsed and refractory patients and was well tolerated at a fixed dose.” A head-to-head phase 3 trial comparing pembrolizumab with BV is ongoing (ClinicalTrials.gov Identifier: NCT02684292).
- Chen R, Zinzani PL, Fanale MA, et al. Phase II study of the efficacy and safety of pembrolizumab for relapsed/refractory classic Hodgkin lymphoma. J Clin Oncol. 2017 Apr 25. doi: 10.1200/JCO.2016.72.1316 [Epub ahead of print]
- Pembrolizumab (KEYTRUDA) for classical Hodgkin lymphoma. US Food and Drug Administration website. https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm546893.htm. Updated March 15, 2017. Accessed April 24, 2017.