As you know, pathological complete response is the complete disappearance of tumour cells in breast and in nodes in early breast cancer. You heard that the FDA and EMA can give an accelerated approval for any agent that increases pathological complete response because pCR is a surrogate of overall survival. So putting in the clinical practice the presentation of this study, the combination of pembrolizumab plus chemotherapy in the neoadjuvant setting increased pathological complete response from 51% in the standard arm to 64% in the combination arm. So this is really a breakthrough result because you can increase pCR and potentially you can increase also overall survival or disease free survival.
What we can tell about the patients who had the response or had no response to immune checkpoint. So for all these patients we have a baseline biopsy and for those who had no response we have the residual tumour. The implications are really great from a scientific point of view – we can better identify those patients who will be more likely responsive to immunotherapy because if we characterise those patients who had a pCR we can really identify those patients who will maximise the benefit of immunotherapy.
But for those who had no response we have the residual tumour and we can better understand the mechanism of resistance to immune checkpoint inhibitors. So this is really an important trial for which we will have a lot of data also in the future.
So, I believe in conclusion that the combination of immunotherapy plus chemotherapy for early triple negative breast cancer, according to the data here presented, is a new standard of care for early breast cancer, the triple negative subtype.