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June 2019: Clinical results and biomarker analysis of the randomised phase II GeparNuevo study

04.07.2019

We are pleased to inform you that the results of the randomised phase II GeparNuevo (GBG 89) study that aimed to investigate the addition of durvalumab, a human monoclonal antibody targeting programmed cell death ligand-1 (PD-L1) to an anthracycline taxane-based neoadjuvant therapy in early triple negative breast cancer (TNBC) has been published in the Annals of Oncology.

Between June 2016 and October 2017, 235 patients were screened of whom 174 patients were randomised to receive durvalumab (N=88) or placebo (N=86) given every 4 weeks in addition to nab-paclitaxel followed by does-dense epirubicin/cyclophosphamide (EC) therapy. In the window-phase durvalumab/placebo alone was given 2 weeks before start of nab-paclitaxel. After 117 patients have been recruited, the window-phase was stopped based on the Independent Data Monitoring Committee (IDMC) recommendation. Median age at study entry was 49.5 years (range 23-76); 47 patients (27%) were younger than 40 years; 113 (65%) had stage ≥IIA disease, 25 (14%) had high stromal tumour infiltrating lymphocytes (sTILs) and 87% (138 of 158) were PD-L1-positive. Pathological complete response (pCR=ypT0 ypN0) rate of patients treated with durvalumab in addition to nab-paclitaxel followed by EC was numerically higher but not statistically significant compared to the pCR rate of patients treated with chemotherapy alone (53.4% vs 44.2%; OR=1.45 [95%CI 0.80-2.63]; unadjusted Wald p=0.224). Durvalumab effect was seen only in the window cohort (pCR 61.0% vs 41.4%, OR=2.22 [95%CI 1.06-4.64]; p=0.035; interaction p=0.048). In both arms, significantly increased pCR rates (p<0.01) were observed with higher sTILs. There was a trend for increased pCR rates in the PD-L1-positive tumours. The most common immune-related adverse events were thyroid dysfunction any grade. These results demonstrated that induction therapy with durvalumab seems beneficial and should be further investigated in primary TNBC.

Loibl S, Untch M, Burchardi N, Huober J, Sinn BV, Blohmer JU, Grischke EM, Furlanetto J, Tesch H, Hanusch C, Engels K, Rezai M, Jackisch C, Schmitt WD, von Minckwitz G, Thomalla J, Kümmel S, Rautenberg B, Fasching PA, Weber K, Rhiem K, Denkert C, Schneeweiss A. A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple negative breast cancer - clinical results and biomarker analysis of GeparNuevo study. Ann Oncol. 2019 May 16. [Epub ahead of print]

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