ASCO 2016. Abstract 7555. Pembrolizumab for relapsed/refractory classical Hodgkin lymphoma (R/R cHL): phase 2 KEYNOTE-087 study.
Robert W. Chen et al.
Results: At time of data cutoff (Feb 1, 2016), 60 pts were evaluable for cohorts 1 and 2. Median (range) age was 36 (19-64) years in cohort 1 and 33 (20-71) in cohort 2. 67% received ≥ 4 prior lines of therapy, and by design 100% failed prior BV. ORR among 30 pts in cohort 1 is 70% (95% CI, 51-85). 6 pts (20%) achieved CR (residual mass permitted if PET negative), 15 (50%) PR, and 6 (20%) stable disease as best response. ORR among 30 pts in cohort 2 is 80% (95% CI, 61-92). 8 pts (27%) achieved CR, 16 (53%) PR, and 4 (13%) stable disease as best response. With a median of 6 treatment cycles, most common treatment-related AEs in the combined cohorts are pyrexia (13%), diarrhea (8%), fatigue, back pain, platelet count decrease, dry skin, and cough (7% each).
Conclusions: PD-1 blockade with pembrolizumab shows early responses in heavily pretreated cHL pts. Of note, pembrolizumab shows an unprecedented high ORR (80%) in pts who were not candidates for ASCT and failed previous BV therapy. Clinical trial information: NCT02453594
CARE Faculty Perspective: In April, the FDA granted breakthrough designation therapy to pembrolizumab as a treatment for patients with relapsed/refractory classical cHL, based on the early findings from the KEYNOTE-13 study as well as the unpublished findings from the KEYNOTE-87 trial. ASCO Reported on the results from the latter, showing that pembrolizumab has early, durable, responses. We look forward to this agent being approved in Canada.