This is actually a clinical trial in pancreatic cancer patients and this is a randomised phase II study of olaparib plus pembrolizumab versus olaparib alone as maintenance therapy for patients with pancreatic cancer.
Could you outline the methodology and findings?
Basically, the POLAR trial back in 2019 really laid the groundwork for olaparib as maintenance therapy in patients with germline BRCA1 and BRCA2 mutations. This showed an improvement in progression free survival, however, there was not a benefit in overall survival. So there was really an urgent need to look for potential mechanisms of actually deepening that response and sustaining that response. So that’s where this idea came up in terms of actually adding in immune checkpoint inhibitors to olaparib to try to potentially sustain and deepen that response.
Basically, what we do know is that in terms of genomic instability, genomic instability does enhance the effectiveness of immune checkpoint inhibitors in that population of patients. So we wanted to explore that in a randomised fashion.
What impact could these findings have in the clinic?
In terms of this particular clinical trial, we did not actually see an improvement in the progression free survival as we had expected; we were actually looking for a very high bar. We were looking to actually improve progression free survival from 7 months up to 11.7 months. So we did see signs of activity, we did see that the progression free survival with the experimental group had increased up to about 8.2 months from about 6.4, and the response rate was higher in the combination group, up to 28% compared to 18%. However, we did not have statistical significance and the trial was closed at the interim analysis.