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SGN-35 pivotal phase 2

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Phase 2N = 102NCT00848926

Population
Relapsed or refractory CD30-positive Hodgkin lymphoma after autologous stem-cell transplantation; 102 patients treated.
Design
Multinational, open-label, single-arm phase 2 study of brentuximab vedotin 1.8 mg per kilogram intravenously every 3 weeks (maximum 16 cycles) after autologous stem-cell transplantation. CD30 positivity confirmed by central pathology review. Primary endpoint: overall objective response rate by an independent radiology review facility.
Primary endpoint
ORR
Arms
  • Brentuximab vedotin (experimental, n = 102): Brentuximab vedotin 1.8 mg per kilogram intravenously every 3 weeks, maximum 16 cycles
People
Younes A
Show the numbers
Results reported for SGN-35 pivotal phase 2
EndpointAnalysisBrentuximab vedotinControlEffect
ORRAll 102 treated patientsprimaryYounes 201275%—Per independent radiology review facility. No confidence interval is given in the abstract.
CR rateAll 102 treated patientsprimaryYounes 201234%——
PFSAll 102 treated patientsprimaryYounes 2012median 5.6 months—Single-arm median progression-free survival; the abstract gives no confidence interval. The median duration of response for patients in complete remission was 20.5 months.
Results reported for SGN-35 pivotal phase 2
EndpointAnalysisBrentuximab vedotinControlEffect
ORRAll 102 treated patientsprimaryYounes 201275%—Per independent radiology review facility. No confidence interval is given in the abstract.
CR rateAll 102 treated patientsprimaryYounes 201234%——
PFSAll 102 treated patientsprimaryYounes 2012median 5.6 months—Single-arm median progression-free survival; the abstract gives no confidence interval. The median duration of response for patients in complete remission was 20.5 months.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Brentuximab vedotin (experimental)

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

Data table (modelled values)
MonthsBrentuximab vedotin
0100.0%
461.0%
742.0%
1125.6%
1417.7%
Primary publication: Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, et al. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012;30(18):2183-9. PubMedDOI

Appears in

Sources

  1. Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, et al. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012;30(18):2183-9.

    PubMedDOI