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.
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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).
Reference
- 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.
