95751-114

MAGE-A3 cancer immunotherapeutic in resected stage IB-III NSCLC patients with or without sequential or concurrent chemotherapy.

Category: 
Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Session Type and Session Title: 
Poster Discussion Session, Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
Abstract Number: 

7013

Citation: 

J Clin Oncol 30, 2012 (suppl; abstr 7013)

Author(s): 

Jean-Louis Pujol, Johan F. Vansteenkiste, Tommaso Martino De Pas, Djordje Atanackovic, Martin Reck, Michiel Thomeer, Jean-Yves Douillard, Gianpiero Fasola, Vanessa Potter, Paul Taylor, Lionel Bosquee, Muriel Debois, Pedro de Sousa Alves, Jamila Louahed, Frederic Lehmann, Vincent G. Brichard; CHU - Maladies Respiratoires, Montpellier, France; University Hospital Gasthuisberg, Leuven, Belgium; Medical Oncology Unit of Respiratory Tract and Sarcomas, New Drugs Development Division, European Institute of Oncology, Milan, Italy; University Medical Center Hamburg-Eppendorf, Center of Oncology/Hematology, Hamburg, Germany; Hospital Großhansdorf, Department of Thoracic Oncology, Großhansdorf, Germany; Ziekenhuis Oost-Limburg, Research Cluster Oncology University Hasselt, Genk, Belgium; ICO Centre René Gauducheau, Saint-Herblain, France; Department of Oncology, University Hospital of Udine, Udine, Italy; City Campus, Department of Medical Oncology, Nottingham, United Kingdom; University Hospitals of South Manchester, North West Lung Center, Manchester, United Kingdom; Centre Hospitalier Universitaire (CHU), Liège, Belgium; GlaxoSmithKline Biologicals, Rixensart, Belgium


Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: Previous trials with the MAGE-A3 recombinant (rec) protein formulated with an immunostimulant have shown induction of specific immune responses and signals of clinical activity in different cancer diseases. In this phase I/II study (NCT 00455572), we evaluated the safety profile of the MAGE-A3 cancer immunotherapeutic (CI), formulated with the rec MAGE-A3 protein and the AS15 immunostimulant, and the induction of specific immune response with or without adjuvant chemotherapy (CT). Methods: MAGE-A3 CI was administered i.m. 8q3w in resected MAGE-A3+ stage IB-III NSCLC patients (pts). Three cohorts (C) were evaluated: Immunization with concurrent cisplatin plus vinorelbine (C1), sequentially after the same CT (C2) or with no CT (C3). The anti-MAGE-A3 humoral and cellular immune responses were evaluated by ELISA and intracellular cytokine staining (T cells producing both IFNg and TNF) respectively. Adverse Events (AEs) were graded according to CTCAE v. 3.0. Results: A total of 38/55 treated pts received the 8 doses schedule (15/19 in C1, 14/18 in C2, 9/18 in C3). Almost all pts reported at least one AE, mostly general constitutional disorders and administration site reactions. Six patients reported related grade 3 AEs. No related grade 4-5 AE or related SAE were reported. Immunogenicity results in the total treated population are reported in the table below. Conclusions: In this trial, patients in cohorts 2 and 3 correspond to the two populations enrolled in the Phase III MAGRIT trial evaluating the same MAGE-A3 CI. The phase I/II results suggest that this CI is well tolerated and induces in all treated pts specific antibodies against MAGE-A3 after 4 doses in presence or not of concurrent or sequential adjuvant CT. About 25% of the treated pts are considered as CD4 responders in presence or not of concurrent or sequential adjuvant CT.
Cohort C1
n/N
C2
n/N
C3
n/N
Seropositivity*
After 4 doses
After 8 doses
-
15/15
15/15
-
15/15
13/13
-
12/12
9/9
CD4 response** 4/11 4/15 2/8
CD8 response** 1/11 1/15 0/8

n: number of seropositive/responding patients; N: Total number of pts with available samples; *: Anti-MAGE-A3-Antibodies; **: Responders are pts with a response ratio baseline/any timepoint >=4 folds.