Meeting
2017 ASCO Annual Meeting
A randomized phase II neoadjuvant study (GeparNuevo) to investigate the addition of durvalumab, a PD-L1 antibody, to a taxane-anthracycline containing chemotherapy in triple negative breast cancer (TNBC).
Authors
Sibylle Loibl
German Breast Group, Neu-Isenburg, Germany
Sibylle Loibl , Michael Untch , Nicole Burchardi , Jens Bodo Huober , Jens Uwe Blohmer , Eva-Maria Grischke , Jenny Furlanetto , Hans Tesch , Claus Hanusch , Mahdi Rezai , Christian Jackisch , Wolfgang D Schmitt , Gunter Von Minckwitz , Jörg Thomalla , Sherko Kummel , Beate Rautenberg , Peter A. Fasching , Kerstin Rhiem , Carsten Denkert , Andreas Schneeweiss
Organizations
German Breast Group, Neu-Isenburg, Germany, Clinic for Gynecology, Gynecologic Oncology, and Obstetrics, Berlin, Germany, German Breast Group (GBG), Neu-Isenburg, Germany, University of Ulm, Ulm, Germany, Department of Gynecology/Breast Center of the Charité, Berlin, Germany, Universitӓts-Frauenklinik Tubingen, Eberhard Karls University, Tubingen, Germany, Oncological Practice Bethanien, Frankfurt, Germany, Rotkreuzklinikum, Munich, Germany, Luisenkrankenhaus Düsseldorf, Senologie, Düsseldorf, Germany, Sana Klinikum Offenbach GmbH, Offenbach, Germany, Institute of Pathology, Charité University Hospital, Berlin, Germany, Hematology and Oncology Group Practice, Koblenz, Germany, Breast Unit, Kliniken Essen-Mitte, Essen, Germany, Department of Gynaecology and Obstetrics, University Clinic Freiburg, Freiburg, Germany, University of Erlangen, Erlangen, Germany, Center for Familial Breast and Ovarian Cancer and Center for Integrated Oncology (CIO), Medical Faculty, University of Cologne and University Hospital Cologne, Cologne, Germany, Charité Universitätsmedizin Berlin - Institut für Pathologie, Berlin, Germany, University of Heidelberg, Heidelberg, Germany
Research Funding
Pharmaceutical/Biotech Company
Background: Adding an anti-PD-L1 checkpoint inhibitor durvalumab to standard chemotherapy (CT) may increase pathological complete response (pCR) in patients (pts) with TNBC. Methods: GeparNuevo randomizes pts to durvalumab (D) 1.5 g i.v. or placebo (pl) every 4 weeks (wks). D/pl monotherapy (0.75 g i.v.) is given for the first 2 wks (window phase), followed by a biopsy and D/pl plus nab-paclitaxel (nP) 125 mg/m² weekly for 12 wks, followed by D/pl plus epirubicin/cyclophosphamide (EC) q2 wks for 4 cycles. Randomization is stratified by stromal TILs (sTILs) (low (≤10%), intermediate (11-59%), high (≥60%)). Pts with primary cT1b-cT4a-d disease, centrally confirmed TNBC, and sTILs status can be included. Primary objective compares pCR (ypT0 ypN0) rates. Secondary objectives are pCR rates in stratified subpopulations and according to other pCR definitions; response rates; breast conservation rate; toxicity; compliance and survival. Change in sTILs, Ki67 and other immune biomarkers before CT, after the window phase and after CT will be correlated with outcome. The first 10, 20 and 30 pts will be included in safety interim analyses (SIA). Sample size was planned assuming a pCR rate of 48% for pl (nP treated TNBC cohort in GeparSepto) and of 66% for D (as clinically meaningful benefit), requiring 158 pts to show superiority of D (2-sided α = 0.2, 80% power). Assuming a 10% drop-out rate 174 pts will be randomized. Results: Since 6/2016, 50 pts were recruited within 16 sites; data are presented as available until 01/2017. Median age is 49 years; 86% NST and G3 tumors; sTILs categories 40% low, 40% intermediate and 20% high. Blinded SIA was performed. No pt interrupted D/pl, one nP and one EC. Treatment delay was observed in 9 pts (20.0%) in D/pl, 18 (41.9%) in nP and 2 (13.3%) in EC; dose was reduced in 10 pts (23.3%) in nP and in 4 (26.7%) in EC. 10 pts (20%) had at least one grade 3-4 AE: 4 haematological and 6 non-haematological AEs. 4 SAEs and 5 immune related AEs were reported. 2 pts discontinued study treatment prematurely in the EC phase. Conclusions: The addition of D to standard nP-EC is feasible and does not result in an increased toxicity. Clinical trial information: NCT02685059
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Abstract Details
Session Type
Poster Session
Session Title
Developmental Therapeutics—Immunotherapy
Track
Developmental Therapeutics and Translational Research,Immunotherapy
Sub Track
Immune Checkpoint Inhibitors
Clinical Trial Registration Number
NCT02685059
Citation
J Clin Oncol 35, 2017 (suppl; abstr 3062)
DOI
10.1200/JCO.2017.35.15_suppl.3062
Abstract #
3062
Poster Bd #
157
Abstract Disclosures
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