Τίτλος:
Phase II Study of the Efficacy and Safety of Pembrolizumab for
Relapsed/Refractory Classic Hodgkin Lymphoma
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Purpose
Hodgkin Reed-Sternberg cells harbor alterations in chromosome 9p24.1,
leading to overexpression of programmed death-ligand 1 (PD-L1) and
PD-L2. Pembrolizumab, a programmed death 1-blocking antibody,
demonstrated a high overall response rate (ORR) in patients with
relapsed or refractory classic Hodgkin lymphoma (rrHL) in phase I
testing.
Methods
KEYNOTE-087 (ClinicalTrials.gov identifier, NCT02453594) was a
single-arm phase II study of pembrolizumab in three cohorts of patients
with rrHL, defined on the basis of lymphoma progression after (1)
autologous stem cell transplantation (ASCT) and subsequent brentuximab
vedotin (BV); (2) salvage chemotherapy and BV, and thus, ineligible for
ASCT because of chemoresistant disease; and (3) ASCT, but without BV
after transplantation. Patients received pembrolizumab 200 mg once every
3 weeks. Response was assessed every 12 weeks. The primary end points
were ORR by central review and safety.
Results
A total of 210 patients were enrolled and treated (69 in cohort 1, 81 in
cohort 2, and 60 in cohort 3). At the time of analysis, patients
received a median of 13 treatment cycles. Per central review, the ORR
was 69.0% (95% CI, 62.3% to 75.2%), and the complete response rate
was 22.4% (95% CI, 16.9% to 28.6%). By cohort, ORRs were 73.9% for
cohort 1, 64.2% for cohort 2, and 70.0% for cohort 3. Thirty-one
patients had a response >= 6 months. The safety profile was largely
consistent with previous pembrolizumab studies.
Conclusion
Pembrolizumab was associated with high response rates and an acceptable
safety profile in patients with rrHL, offering a new treatment paradigm
for this disease. (C) 2017 by American Society of Clinical Oncology
Συγγραφείς:
Chen, Robert
Zinzani, Pier Luigi
Fanale, Michelle A.
Armand,
Philippe
Johnson, Nathalie A.
Brice, Pauline
Radford, John
and Ribrag, Vincent
Molin, Daniel
Vassilakopoulos, Theodoros P.
and Tomita, Akihiro
von Tresckow, Bastian
Shipp, Margaret A. and
Zhang, Yinghua
Ricart, Alejandro D.
Balakumaran, Arun and
Moskowitz, Craig H.
KEYNOTE-087 Investigators
Περιοδικό:
World Journal of Clinical Oncology
Εκδότης:
AMER SOC CLINICAL ONCOLOGY 2318 MILL ROAD, STE 800, ALEXANDRIA, VA 22314 USA
DOI:
10.1200/JCO.2016.72.1316
