mCRPC in focus
Transcript: Olaparib for mCRPC: rwOS
Dr Neeraj Agarwal, Professor Karim Fizazi, Dr Bárbara Vieira Lima Aguiar Melão, and Professor Axel Merseburger
All transcripts are created from interview footage and directly reflect the content of the interview at the time. The content is that of the speaker and is not adjusted by Medthority.
There was an abstract from a community-based practise, AI [indistinct] oncology 144 patient data from real-world patients. And these are the patients who had mCRPC and they had homologous recombination of mutations. And the reason we included this abstract is to basically talk about the real world results with PARP inhibitors and how they compare with the registration trials.
So, just for our listeners' recollection, PROFOUND was the first phase three trial, where patients were selected based on a biomarker and it was positive. And then in this trial, olaparib, a PARP inhibitor, was compared with a alternate ARPI in patients who had disease progression on a prior ARPI. And they could have received docetaxel chemotherapy, and many patients did. And in this trial, in patients with BRCA 1, BRCA 2, and ATM mutations, treatment with olaparib significantly improved radiographic progression-free survival, about 60% reduction, risk of progression, and improved overall survival with about 30% reduction in risk of death despite 80% crossover. In this trial, where patients receive olaparib. So, treatment with olaparib improved PFS, radiographic PFS, and OS compared to alternate ARPI. And if you look at the overall survival, it was 19 months in these patients after they started olaparib, and it was about 14 months in the control arm.
Now, if you look at the real-world, community-based database, and obviously, this is not a randomised trial, so I will keep it simple and quick. We saw very similar overall survival and radiographic progression-free survival, or I would say time to next therapy, which is the surrogate, because these are community-based databases. We don't do scans every three months and don't do a blinded independent review of these scans. So, time to next therapy's usually used as a surrogate for PFS. And what we saw was quite, the results were quite similar. Obviously, more benefit in patients with BRCA 1 and BRCA 2 mutations. But overall survival and time to next therapy were quite similar to what we saw in the PROFOUND trial.
And the message here is that these trials, registration trials, which are leading to approval of these newer therapies, we can expect to see similar magnitude of benefit, maybe little bit lesser, because real-world patients are not as robust as clinical trial patients. But I think the benefit remains, the benefit is there.
So, I think challenge will be to make sure how to incorporate those data into the real-world practise and how to improve implementation of those data, because we have seen challenges about how ARPIs are not even being used in mCRPC setting and many of these therapies backed by level when evidence are not being actually utilised by the prostate cancer community.
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