We are pleased to inform you that long-term outcomes from GeparNuevo trial have been published in Annals of Oncology.
GeparNuevo (NCT02685059) was a multicenter, prospective, randomized, double-blind, placebo-controlled phase II trial investigating the efficacy of neoadjuvant chemotherapy including nab-paclitaxel, followed by dose-dense epirubicin/cyclophosphamide (EC) with durvalumab versus placebo in patients with primary non-metastatic TNBC. Primary analysis showed that the addition of durvalumab to neoadjuvant chemotherapy led to a moderate increase in pCR rate by absolute 9% (p=0.287) (Loibl et al. Ann Oncol.2019).
This study reported the secondary endpoints included invasive disease-free survival (iDFS), distant disease-free survival (DDFS) and overall survival (OS), which were particularly interesting considering the moderate increase in pCR rate as well as the restriction of the checkpoint inhibitor to the neoadjuvant therapy phase.
Conclusion: Durvalumab added to neoadjuvant chemotherapy in TNBC significantly improved survival despite a modest pCR increase and no adjuvant component of durvalumab. Additional studies are needed to clarify the optimal duration and sequence of CPIs in the treatment of early TNBC.
Loibl S, Schneeweiss A, Huober J, et al. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response. Ann Oncol. 2022 Aug 9:S0923-7534(22)03791-7. doi:10.1016/j.annonc.2022.07.