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CheckMate 205

Non-Comparative, Multi-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Classical Hodgkin Lymphoma (cHL) Subjects

Phase 2N = 243NCT02181738

Population
Relapsed or refractory classic Hodgkin lymphoma after failure of autologous stem-cell transplantation.
Design
Multicentre, multicohort, single-arm phase 2 study of nivolumab 3 mg per kilogram every 2 weeks until disease progression or unacceptable toxicity. Cohorts: brentuximab vedotin-naive (A), brentuximab vedotin after autologous transplant (B), brentuximab vedotin before and/or after transplant (C). Primary endpoint: objective response rate per independent radiology review committee. 243 patients were treated in the extended follow-up report.
Primary endpoint
ORR
Arms
  • Nivolumab (experimental): Nivolumab 3 mg per kilogram intravenously every 2 weeks until progression, death, unacceptable toxicity or withdrawal
People
Younes A
Show the numbers
Results reported for CheckMate 205
EndpointAnalysisNivolumabControlEffect
ORRPatients treated after failure of both autologous stem-cell transplantation and brentuximab vedotin (80 patients)primarymedian follow-up 8.9 monthsYounes 201666.3% (54.8–76.4%)—53 of 80 patients had an independent-review objective response. Median number of previous therapies was four. This is the first report of one cohort; later extended follow-up covers all three cohorts.
ORRAll treated patients in the three cohorts (243 patients)long term-updatemedian follow-up 18 monthsArmand 201869% (63–75%)—Objective response rate ranged from 65% to 73% across the three cohorts; per independent radiology review committee.
DORAll treated patients in the three cohorts (243 patients)long term-updatemedian follow-up 18 monthsArmand 2018median 16.6 months (13.2–20.3)——
PFSAll treated patients in the three cohorts (243 patients)long term-updatemedian follow-up 18 monthsArmand 2018median 14.7 months (11.3–18.5)—Single-arm median progression-free survival; not comparable with randomised progression-free survival in other trials.
Results reported for CheckMate 205
EndpointAnalysisNivolumabControlEffect
ORRPatients treated after failure of both autologous stem-cell transplantation and brentuximab vedotin (80 patients)primarymedian follow-up 8.9 monthsYounes 201666.3% (54.8–76.4%)—53 of 80 patients had an independent-review objective response. Median number of previous therapies was four. This is the first report of one cohort; later extended follow-up covers all three cohorts.
ORRAll treated patients in the three cohorts (243 patients)long term-updatemedian follow-up 18 monthsArmand 201869% (63–75%)—Objective response rate ranged from 65% to 73% across the three cohorts; per independent radiology review committee.
DORAll treated patients in the three cohorts (243 patients)long term-updatemedian follow-up 18 monthsArmand 2018median 16.6 months (13.2–20.3)——
PFSAll treated patients in the three cohorts (243 patients)long term-updatemedian follow-up 18 monthsArmand 2018median 14.7 months (11.3–18.5)—Single-arm median progression-free survival; not comparable with randomised progression-free survival in other trials.
Illustrative — modelled from reported values, not trial data. DOR, long term-update.
0%25%50%75%100%010203040Months (modelled)
  • Nivolumab (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsNivolumab
0100.0%
1065.9%
2141.6%
3127.4%
4217.3%
Illustrative — modelled from reported values, not trial data. PFS, long term-update.
0%25%50%75%100%0102030Months (modelled)
  • Nivolumab (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsNivolumab
0100.0%
965.4%
1842.8%
2826.7%
3717.5%
Primary publication: Younes A, Santoro A, Shipp M, Zinzani PL, Timmerman JM, Ansell S, et al. Nivolumab for classical Hodgkin's lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin: a multicentre, multicohort, single-arm phase 2 trial. Lancet Oncol. 2016;17(9):1283-94. PubMedDOI

Appears in

Sources

  1. Younes A, Santoro A, Shipp M, Zinzani PL, Timmerman JM, Ansell S, et al. Nivolumab for classical Hodgkin's lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin: a multicentre, multicohort, single-arm phase 2 trial. Lancet Oncol. 2016;17(9):1283-94.

    PubMedDOI

  2. Armand P, Engert A, Younes A, Fanale M, Santoro A, Zinzani PL, et al. Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial. J Clin Oncol. 2018;36(14):1428-1439.

    PubMedDOI