Journal of Oncology / 2019 / Article / Tab 2

Review Article

Immune Checkpoint Inhibition in Classical Hodgkin Lymphoma: From Early Achievements towards New Perspectives

Table 2

Clinical trials of immune checkpoint inhibitors in cHL.

StudyYearDrug, doseDesignPhaseClinical settingNo. of patientsORR, %CR, %PFS

Ansell et al. (Checkmate 039) [7] 2015Nivolumab, 3 mg/kg iv every 2 weeks until complete response, tumor
progression, or excessive toxic effects
PIR/R23871786% at 24 weeks

Armand et al. Checkmate 205 updated results (ASH 2018) [58]2018Nivolumab, 3 mg/kg iv every 2 weeks until disease progression,
death, unacceptable toxicity, withdrawal of consent, or
study end.∗
Patients in cohort C discontinue nivolumab after 1 year in persistent CR and could resume treatment if they relapsed within 2 years of the last dose
P
Composed of 3 cohorts
IIR/R2436916Median PFS 15 months
Cohort A
(no exposition to BV)
636529Median PFS 17 months
Cohort B (treatment with BV after auto-HSCT)806813Median PFS 12 months
Cohort C (treatment with BV before and/or after auto-HSCT failure)1007312Median PFS 15 months

Maruyama et al. [60]2017Nivolumab, 3 mg/kg iv on Day 1 each 14-day cycle.PIIR/R1781.323.560% at 6 months

Armand et al. (Keynote 013) [61]2016Pembrolizumab iv
at a dose of 10 mg/kg every 2 weeks
PIR/R31651669% at 24 weeks, 46% at 52 weeks

Zinzani et al. Keynote 087 updated results (ASH 2018) [63]2018Pembrolizumab, 200 mg iv every 3 weeks
without premedication for a maximum of 24 months or until documented
confirmed disease progression, intolerable toxicity, or investigator
decision
P
Composed of 3 cohorts
IIR/R21071.927.6Median PFS 13.7 months
Cohort 1 (progression after auto-HSCT and BV)6976.826.1Median PFS 16.4 months
Cohort 2 (progression after salvage chemotherapy and BV, but ineligible for auto-HSCT because of chemoresistant disease)8166.725.9Median PFS 11.1 months
Cohort 3 (progression after auto-HSCT, without BV)6073.331.7Median PFS 19.4 months

Shi et al. (ORIENT-1) [68]2019Sintilimab, 200mg iv once every 3 weeks, until disease progression, death, unacceptable toxicity or withdrawal of consent, for a maximum of 24 monthsPIIR/R9280,43477.6% at 6 months

Herbaux et al. [71]2017Nivolumab, 3 mg/kg iv once every
2 weeks without premedication until disease progression or unacceptable
toxicity as assessed by investigators
R-R/R after allo-HSCT20954258.2% at 12 months

Haverkos et al. [72]2017Nivolumab 3mg/kg iv every 2 weeks (n=28) or Pembrolizumab 200mg iv every 3 weeks (n=2)R-R/R after allo-HSCT307950Median PFS 591 days

BV = brentuximab vedotin, CR= complete response, HSCT= hematopoietic stem cell transplantation, IV = intravenously, NA = Not Available, ORR= overall response rate, P= prospective, PFS= progression free survival, R= retrospective, R/R= relapsed or refractory disease.
∗Amendment in July 2014: patients continued treatment beyond progression if protocol-predefined criteria were met (i.e. stable performance status and deriving perceived clinical benefit). Patients treated beyond initial progression were required to discontinue in the event of further progression (>10% further increase in tumor burden).

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