The GeparX study is also a neoadjuvant study in all-comers of early breast cancer patients, so triple negative, HER2 positive and luminal breast cancer patients are enrolled.
There are two main questions: first, the addition of durvalumab to an anthracycline taxane based chemotherapy, does it play a role; does it increase PCR rates?
We have seen here denosumab studies in early breast cancer going in one or the other direction.
The second question: what is the best schedule for nab-paclitaxel, the weekly 125mg or the schedule where you give the nab-paclitaxel on days 1 and 8 and then pause on day 15.
So in two out of three weeks schedule. So these are the main questions.
Another investigation we are doing in the GeparX is looking at the biosimilar added to pertuzumab which we investigate in 150 patients the safety profile and the efficacy in this combination because there haven’t been many combinations with biosimilars added to pertuzumab so far.
What we see is that when we look at the safety profile denosumab is very safe, it doesn’t add anything to the toxicity we observed with the chemotherapy.
What we see is that the two out of three regimen seems to be slightly better tolerated, especially in terms of sensory neuropathy.
But what we also see, because we add carboplatin in the triple negative breast cancer patients that this adds to the toxicity, especially the hematologic toxicity.
But otherwise the toxicity profile is as expected and the study, hopefully, will continue as planned after we have presented the data to the IDMC.