Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma

Ajay K. Gopal, Robert Chen, Scott E. Smith, Stephen Maxted Ansell, Joseph D. Rosenblatt, Kerry J. Savage, Joseph M. Connors, Andreas Engert, Emily K. Larsen, Xuedong Chi, Eric L. Sievers, Anas Younes

Research output: Contribution to journalArticle

129 Citations (Scopus)

Abstract

We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N = 102) after a median observation period of approximately 3 years.Median overall survival and progression-free survival were estimated at 40.5months and 9.3months, respectively. Improved outcomes were observed in patients who achieved a complete remission (CR) on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73% (95% confidence interval [CI]: 57%, 88%) and 58%(95% CI: 41%, 76%), respectively, in this group (medians not reached).Of the 34 patients who obtained CR, 16 (47%) remain progression-free after a median of 53.3 months (range, 29.0 to 56.2 months) of observation; 12 patients remain progression-free without a consolidative allogeneic stem cell transplant. Younger age, good performance status, and lower disease burden at baseline were characteristic of patients who achieved a CR and were favorable prognostic factors for overall survival. These results suggest that a significant proportion of patients who respond to brentuximab vedotin can achieve prolonged disease control.

Original languageEnglish (US)
Pages (from-to)1236-1243
Number of pages8
JournalBlood
Volume125
Issue number8
DOIs
StatePublished - Feb 19 2015

Fingerprint

Hodgkin Disease
Refractory materials
Transplants
Stem cells
Disease control
Survival
Disease-Free Survival
Stem Cells
Observation
Confidence Intervals
Antibodies
Pharmaceutical Preparations
cAC10-vcMMAE
Survival Rate

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

Cite this

Gopal, A. K., Chen, R., Smith, S. E., Ansell, S. M., Rosenblatt, J. D., Savage, K. J., ... Younes, A. (2015). Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood, 125(8), 1236-1243. https://doi.org/10.1182/blood-2014-08-595801

Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. / Gopal, Ajay K.; Chen, Robert; Smith, Scott E.; Ansell, Stephen Maxted; Rosenblatt, Joseph D.; Savage, Kerry J.; Connors, Joseph M.; Engert, Andreas; Larsen, Emily K.; Chi, Xuedong; Sievers, Eric L.; Younes, Anas.

In: Blood, Vol. 125, No. 8, 19.02.2015, p. 1236-1243.

Research output: Contribution to journalArticle

Gopal, AK, Chen, R, Smith, SE, Ansell, SM, Rosenblatt, JD, Savage, KJ, Connors, JM, Engert, A, Larsen, EK, Chi, X, Sievers, EL & Younes, A 2015, 'Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma', Blood, vol. 125, no. 8, pp. 1236-1243. https://doi.org/10.1182/blood-2014-08-595801
Gopal, Ajay K. ; Chen, Robert ; Smith, Scott E. ; Ansell, Stephen Maxted ; Rosenblatt, Joseph D. ; Savage, Kerry J. ; Connors, Joseph M. ; Engert, Andreas ; Larsen, Emily K. ; Chi, Xuedong ; Sievers, Eric L. ; Younes, Anas. / Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. In: Blood. 2015 ; Vol. 125, No. 8. pp. 1236-1243.
@article{da3179b749204fe99508cbd3427c8849,
title = "Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma",
abstract = "We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N = 102) after a median observation period of approximately 3 years.Median overall survival and progression-free survival were estimated at 40.5months and 9.3months, respectively. Improved outcomes were observed in patients who achieved a complete remission (CR) on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73{\%} (95{\%} confidence interval [CI]: 57{\%}, 88{\%}) and 58{\%}(95{\%} CI: 41{\%}, 76{\%}), respectively, in this group (medians not reached).Of the 34 patients who obtained CR, 16 (47{\%}) remain progression-free after a median of 53.3 months (range, 29.0 to 56.2 months) of observation; 12 patients remain progression-free without a consolidative allogeneic stem cell transplant. Younger age, good performance status, and lower disease burden at baseline were characteristic of patients who achieved a CR and were favorable prognostic factors for overall survival. These results suggest that a significant proportion of patients who respond to brentuximab vedotin can achieve prolonged disease control.",
author = "Gopal, {Ajay K.} and Robert Chen and Smith, {Scott E.} and Ansell, {Stephen Maxted} and Rosenblatt, {Joseph D.} and Savage, {Kerry J.} and Connors, {Joseph M.} and Andreas Engert and Larsen, {Emily K.} and Xuedong Chi and Sievers, {Eric L.} and Anas Younes",
year = "2015",
month = "2",
day = "19",
doi = "10.1182/blood-2014-08-595801",
language = "English (US)",
volume = "125",
pages = "1236--1243",
journal = "Blood",
issn = "0006-4971",
publisher = "American Society of Hematology",
number = "8",

}

TY - JOUR

T1 - Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma

AU - Gopal, Ajay K.

AU - Chen, Robert

AU - Smith, Scott E.

AU - Ansell, Stephen Maxted

AU - Rosenblatt, Joseph D.

AU - Savage, Kerry J.

AU - Connors, Joseph M.

AU - Engert, Andreas

AU - Larsen, Emily K.

AU - Chi, Xuedong

AU - Sievers, Eric L.

AU - Younes, Anas

PY - 2015/2/19

Y1 - 2015/2/19

N2 - We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N = 102) after a median observation period of approximately 3 years.Median overall survival and progression-free survival were estimated at 40.5months and 9.3months, respectively. Improved outcomes were observed in patients who achieved a complete remission (CR) on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73% (95% confidence interval [CI]: 57%, 88%) and 58%(95% CI: 41%, 76%), respectively, in this group (medians not reached).Of the 34 patients who obtained CR, 16 (47%) remain progression-free after a median of 53.3 months (range, 29.0 to 56.2 months) of observation; 12 patients remain progression-free without a consolidative allogeneic stem cell transplant. Younger age, good performance status, and lower disease burden at baseline were characteristic of patients who achieved a CR and were favorable prognostic factors for overall survival. These results suggest that a significant proportion of patients who respond to brentuximab vedotin can achieve prolonged disease control.

AB - We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N = 102) after a median observation period of approximately 3 years.Median overall survival and progression-free survival were estimated at 40.5months and 9.3months, respectively. Improved outcomes were observed in patients who achieved a complete remission (CR) on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73% (95% confidence interval [CI]: 57%, 88%) and 58%(95% CI: 41%, 76%), respectively, in this group (medians not reached).Of the 34 patients who obtained CR, 16 (47%) remain progression-free after a median of 53.3 months (range, 29.0 to 56.2 months) of observation; 12 patients remain progression-free without a consolidative allogeneic stem cell transplant. Younger age, good performance status, and lower disease burden at baseline were characteristic of patients who achieved a CR and were favorable prognostic factors for overall survival. These results suggest that a significant proportion of patients who respond to brentuximab vedotin can achieve prolonged disease control.

UR - http://www.scopus.com/inward/record.url?scp=84923319448&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84923319448&partnerID=8YFLogxK

U2 - 10.1182/blood-2014-08-595801

DO - 10.1182/blood-2014-08-595801

M3 - Article

VL - 125

SP - 1236

EP - 1243

JO - Blood

JF - Blood

SN - 0006-4971

IS - 8

ER -