Phase II trial of ipilimumab in melanoma patients with preexisting humoural immune response to NY-ESO-1
Haag GM, Zoernig I, Hassel JC, Halama N, Dick J, Lang N, Podola L, Funk J, Ziegelmeier C, Juenger S, Bucur M, Umansky L, Falk CS, Freitag A, Karapanagiotou-Schenkel I, Beckhove P, Enk A, Jaeger D (2018)
Publication Type: Journal article
Publication year: 2018
Journal
Book Volume: 90
Pages Range: 122-129
DOI: 10.1016/j.ejca.2017.12.001
Abstract
Background Immune checkpoint therapy has dramatically changed treatment options in patients with metastatic melanoma. However, a relevant part of patients still does not respond to treatment. Data regarding the prognostic or predictive significance of preexisting immune responses against tumour antigens are conflicting. Retrospective data suggested a higher clinical benefit of ipilimumab in melanoma patients with preexisting NY-ESO-1–specific immunity. Patients and methods Twenty-five patients with previously untreated or treated metastatic melanoma and preexisting humoural immune response against NY-ESO-1 received ipilimumab at a dose of 10 mg/kg in week 1, 4, 7, 10 followed by 3-month maintenance treatment for a maximum of 48 weeks. Primary endpoint was the disease control rate (irCR, irPR or irSD) according to immune-related response criteria (irRC). Secondary endpoints included the disease control rate according to RECIST criteria, progression-free survival and overall survival (OS). Humoural and cellular immune responses against NY-ESO-1 were analysed from blood samples. Results Disease control rate according to irRC was 52%, irPR was observed in 36% of patients. Progression-free survival according to irRC was 7.8 months, according to RECIST criteria it was 2.9 months. Median OS was 22.7 months; the corresponding 1-year survival rate was 66.8%. Treatment-related grade 3 AEs occurred in 36% with no grade 4–5 AEs. No clear association was found between the presence of NY-ESO-1–specific cellular or humoural immune responses and clinical activity. Conclusion Ipilimumab demonstrated clinically relevant activity within this biomarker-defined population. NY-ESO-1 positivity, as a surrogate for a preexisting immune response against tumour antigens, might help identifying patients with a superior outcome from immune checkpoint blockade. Clinical trial information: NCT01216696
Involved external institutions
Universitätsklinikum Heidelberg
Germany (DE)
Deutsches Krebsforschungszentrum (DKFZ)
Germany (DE)
Medizinische Hochschule Hannover (MHH) / Hannover Medical School
Germany (DE)
Germany (DE)
Deutsches Krebsforschungszentrum (DKFZ)
Germany (DE)
Medizinische Hochschule Hannover (MHH) / Hannover Medical School
Germany (DE)
How to cite
APA:
Haag, G.M., Zoernig, I., Hassel, J.C., Halama, N., Dick, J., Lang, N.,... Jaeger, D. (2018). Phase II trial of ipilimumab in melanoma patients with preexisting humoural immune response to NY-ESO-1. European Journal of Cancer, 90, 122-129. https://dx.doi.org/10.1016/j.ejca.2017.12.001
MLA:
Haag, G. M., et al. "Phase II trial of ipilimumab in melanoma patients with preexisting humoural immune response to NY-ESO-1." European Journal of Cancer 90 (2018): 122-129.
BibTeX: Download