Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma

Barbara Pro, Ranjana Advani, Pauline Brice, Nancy L. Bartlett, Joseph D Rosenblatt, Tim Illidge, Jeffrey Matous, Radhakrishnan Ramchandren, Michelle Fanale, Joseph M. Connors, Keenan Fenton, Dirk Huebner, Juan M. Pinelli, Dana A. Kennedy, Andrei Shustov

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

This pivotal phase 2 study evaluated the safety and efficacy of brentuximab vedotin in patients with relapsed or refractory (R/R) systemic anaplastic large cell lymphoma (ALCL). After a median observation period of approximately 6 years from first treatment, we examined the durability of remission, progression-free survival (PFS), overall survival (OS), and safety outcomes of patients treated on this trial. Among all enrolled patients (n558), no progressions were observed beyond 40months, and median OS was not reached. Patients with a complete response (CR), as assessed by the investigator (38 of 58, 66%), continued to demonstrate improved outcomes with neither median OS nor PFS reached. Of the 38 CR patients, 16 received a consolidative stem cell transplant (SCT) with median PFS not reached. Among patients who were on-study and in remission at study closure, 16 patients had not received any new treatment after single-Agent brentuximab vedotin other than consolidative SCT. Among this subset of 16 patients, 8 received SCT, and the remaining 8 patients(14% of all enrolledpatients)remained in sustained remissionwithoutconsolidative SCT or any new anticancer therapy. Thirty-Three patients experienced peripheral neuropathy, among whom, the majority (30 of 33, 91%) had experienced resolution or improvement at their last assessment. These final results, which demonstrated a high rate of peripheral neuropathy resolution, and durable remissions in a subset of patients with relapsed or refractory systemic ALCL, provide evidence that single-Agent brentuximab vedotin may be a potentially curative treatment option.

Original languageEnglish (US)
Pages (from-to)2709-2717
Number of pages9
JournalBlood
Volume130
Issue number25
DOIs
StatePublished - Dec 21 2017

Fingerprint

Anaplastic Large-Cell Lymphoma
Transplants
Stem cells
Refractory materials
Stem Cells
Disease-Free Survival
Peripheral Nervous System Diseases
Durability
Survival
cAC10-vcMMAE
Therapeutics
Patient Safety
Research Personnel
Observation

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. / Pro, Barbara; Advani, Ranjana; Brice, Pauline; Bartlett, Nancy L.; Rosenblatt, Joseph D; Illidge, Tim; Matous, Jeffrey; Ramchandren, Radhakrishnan; Fanale, Michelle; Connors, Joseph M.; Fenton, Keenan; Huebner, Dirk; Pinelli, Juan M.; Kennedy, Dana A.; Shustov, Andrei.

In: Blood, Vol. 130, No. 25, 21.12.2017, p. 2709-2717.

Research output: Contribution to journalArticle

Pro, B, Advani, R, Brice, P, Bartlett, NL, Rosenblatt, JD, Illidge, T, Matous, J, Ramchandren, R, Fanale, M, Connors, JM, Fenton, K, Huebner, D, Pinelli, JM, Kennedy, DA & Shustov, A 2017, 'Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma', Blood, vol. 130, no. 25, pp. 2709-2717. https://doi.org/10.1182/blood-2017-05-780049
Pro, Barbara ; Advani, Ranjana ; Brice, Pauline ; Bartlett, Nancy L. ; Rosenblatt, Joseph D ; Illidge, Tim ; Matous, Jeffrey ; Ramchandren, Radhakrishnan ; Fanale, Michelle ; Connors, Joseph M. ; Fenton, Keenan ; Huebner, Dirk ; Pinelli, Juan M. ; Kennedy, Dana A. ; Shustov, Andrei. / Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. In: Blood. 2017 ; Vol. 130, No. 25. pp. 2709-2717.
@article{4b15e5f007364b1b84436f8f0caffb34,
title = "Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma",
abstract = "This pivotal phase 2 study evaluated the safety and efficacy of brentuximab vedotin in patients with relapsed or refractory (R/R) systemic anaplastic large cell lymphoma (ALCL). After a median observation period of approximately 6 years from first treatment, we examined the durability of remission, progression-free survival (PFS), overall survival (OS), and safety outcomes of patients treated on this trial. Among all enrolled patients (n558), no progressions were observed beyond 40months, and median OS was not reached. Patients with a complete response (CR), as assessed by the investigator (38 of 58, 66{\%}), continued to demonstrate improved outcomes with neither median OS nor PFS reached. Of the 38 CR patients, 16 received a consolidative stem cell transplant (SCT) with median PFS not reached. Among patients who were on-study and in remission at study closure, 16 patients had not received any new treatment after single-Agent brentuximab vedotin other than consolidative SCT. Among this subset of 16 patients, 8 received SCT, and the remaining 8 patients(14{\%} of all enrolledpatients)remained in sustained remissionwithoutconsolidative SCT or any new anticancer therapy. Thirty-Three patients experienced peripheral neuropathy, among whom, the majority (30 of 33, 91{\%}) had experienced resolution or improvement at their last assessment. These final results, which demonstrated a high rate of peripheral neuropathy resolution, and durable remissions in a subset of patients with relapsed or refractory systemic ALCL, provide evidence that single-Agent brentuximab vedotin may be a potentially curative treatment option.",
author = "Barbara Pro and Ranjana Advani and Pauline Brice and Bartlett, {Nancy L.} and Rosenblatt, {Joseph D} and Tim Illidge and Jeffrey Matous and Radhakrishnan Ramchandren and Michelle Fanale and Connors, {Joseph M.} and Keenan Fenton and Dirk Huebner and Pinelli, {Juan M.} and Kennedy, {Dana A.} and Andrei Shustov",
year = "2017",
month = "12",
day = "21",
doi = "10.1182/blood-2017-05-780049",
language = "English (US)",
volume = "130",
pages = "2709--2717",
journal = "Blood",
issn = "0006-4971",
publisher = "American Society of Hematology",
number = "25",

}

TY - JOUR

T1 - Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma

AU - Pro, Barbara

AU - Advani, Ranjana

AU - Brice, Pauline

AU - Bartlett, Nancy L.

AU - Rosenblatt, Joseph D

AU - Illidge, Tim

AU - Matous, Jeffrey

AU - Ramchandren, Radhakrishnan

AU - Fanale, Michelle

AU - Connors, Joseph M.

AU - Fenton, Keenan

AU - Huebner, Dirk

AU - Pinelli, Juan M.

AU - Kennedy, Dana A.

AU - Shustov, Andrei

PY - 2017/12/21

Y1 - 2017/12/21

N2 - This pivotal phase 2 study evaluated the safety and efficacy of brentuximab vedotin in patients with relapsed or refractory (R/R) systemic anaplastic large cell lymphoma (ALCL). After a median observation period of approximately 6 years from first treatment, we examined the durability of remission, progression-free survival (PFS), overall survival (OS), and safety outcomes of patients treated on this trial. Among all enrolled patients (n558), no progressions were observed beyond 40months, and median OS was not reached. Patients with a complete response (CR), as assessed by the investigator (38 of 58, 66%), continued to demonstrate improved outcomes with neither median OS nor PFS reached. Of the 38 CR patients, 16 received a consolidative stem cell transplant (SCT) with median PFS not reached. Among patients who were on-study and in remission at study closure, 16 patients had not received any new treatment after single-Agent brentuximab vedotin other than consolidative SCT. Among this subset of 16 patients, 8 received SCT, and the remaining 8 patients(14% of all enrolledpatients)remained in sustained remissionwithoutconsolidative SCT or any new anticancer therapy. Thirty-Three patients experienced peripheral neuropathy, among whom, the majority (30 of 33, 91%) had experienced resolution or improvement at their last assessment. These final results, which demonstrated a high rate of peripheral neuropathy resolution, and durable remissions in a subset of patients with relapsed or refractory systemic ALCL, provide evidence that single-Agent brentuximab vedotin may be a potentially curative treatment option.

AB - This pivotal phase 2 study evaluated the safety and efficacy of brentuximab vedotin in patients with relapsed or refractory (R/R) systemic anaplastic large cell lymphoma (ALCL). After a median observation period of approximately 6 years from first treatment, we examined the durability of remission, progression-free survival (PFS), overall survival (OS), and safety outcomes of patients treated on this trial. Among all enrolled patients (n558), no progressions were observed beyond 40months, and median OS was not reached. Patients with a complete response (CR), as assessed by the investigator (38 of 58, 66%), continued to demonstrate improved outcomes with neither median OS nor PFS reached. Of the 38 CR patients, 16 received a consolidative stem cell transplant (SCT) with median PFS not reached. Among patients who were on-study and in remission at study closure, 16 patients had not received any new treatment after single-Agent brentuximab vedotin other than consolidative SCT. Among this subset of 16 patients, 8 received SCT, and the remaining 8 patients(14% of all enrolledpatients)remained in sustained remissionwithoutconsolidative SCT or any new anticancer therapy. Thirty-Three patients experienced peripheral neuropathy, among whom, the majority (30 of 33, 91%) had experienced resolution or improvement at their last assessment. These final results, which demonstrated a high rate of peripheral neuropathy resolution, and durable remissions in a subset of patients with relapsed or refractory systemic ALCL, provide evidence that single-Agent brentuximab vedotin may be a potentially curative treatment option.

UR - http://www.scopus.com/inward/record.url?scp=85039166729&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85039166729&partnerID=8YFLogxK

U2 - 10.1182/blood-2017-05-780049

DO - 10.1182/blood-2017-05-780049

M3 - Article

C2 - 28974506

AN - SCOPUS:85039166729

VL - 130

SP - 2709

EP - 2717

JO - Blood

JF - Blood

SN - 0006-4971

IS - 25

ER -