A randomized phase II trial of adjuvant galinpepimut-S, WT-1 analogue peptide vaccine, after multimodality therapy for patients with malignant pleural mesothelioma Journal Article

   

Authors:	Zauderer, M. G.; Tsao, A. S.; Dao, T.; Panageas, K.; Lai, W. V.; Rimner, A.; Rusch, V. W.; Adusumilli, P. S.; Ginsberg, M. S.; Gomez, D.; Rice, D.; Mehran, R.; Scheinberg, D. A.; Krug, L. M.
Article Title:	A randomized phase II trial of adjuvant galinpepimut-S, WT-1 analogue peptide vaccine, after multimodality therapy for patients with malignant pleural mesothelioma
Abstract:	Purpose: Determine the 1-year progression-free survival (PFS) rate among patients with malignant pleural mesothelioma (MPM) receiving the WT1 peptide vaccine galinpepimut-S after multimodality therapy versus those receiving control adjuvants. Experimental Design: This double-blind, controlled, two center phase II trial randomized MPM patients after surgery and another treatment modality to galinpepimut-S with GM-CSF and Montanide or GM-CSF and Montanide alone. An improvement in 1-year PFS from 50% to 70% was the predefined efficacy threshold, and 78 patients total were planned. The study was not powered for comparison between the two arms. Results: Forty-one patients were randomized. Treatment-related adverse events were mild, self-limited, and not clinically significant. On the basis of a stringent prespecified futility analysis (futility ¼ 10 of 20 patients on one arm experiencing progression < 1 year), the control arm closed early. The treatment arm was subsequently closed because of the resultant unblinding. The PFS rate at 1 year from beginning study treatment was 33% and 45% in the control and vaccine arms, respectively. Median PFS was 7.4 months versus 10.1 months and median OS was 18.3 months versus 22.8 months in the control and vaccine arms, respectively. Conclusions: The favorable safety profile was confirmed. PFS and OS were greater in those who received vaccine, but the trial was neither designed nor powered for comparison between the arms. On the basis of these promising results, the investigators are planning a larger randomized trial with greater statistical power to define the optimal use and benefit of galinpepimut-S in the treatment of MPM. © 2017 American Association for Cancer Research.
Journal Title:	Clinical Cancer Research
Volume:	23
Issue:	24
ISSN:	1078-0432
Publisher:	American Association for Cancer Research
Date Published:	2017-12-15
Start Page:	7483
End Page:	7489
Language:	English
DOI:	10.1158/1078-0432.ccr-17-2169
PROVIDER:	scopus
PMCID:	PMC5732877
PUBMED:	28972039
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-85038565260&doi=10.1158%2f1078-0432.CCR-17-2169&partnerID=40&md5=2d090feb039ca1a92c7353f86c9fe85c
Notes:	Article -- Export Date: 2 January 2018 -- Source: Scopus

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