AstraZeneca’s Camille Hertzka Addresses rPFS in mCRPC

Camille Hertzka, vice president, head of oncology, US Medical, AstraZeneca, clarifies testing for the HRR mutation in metastatic castrate-resistant prostate cancer (mCRPC) and the predictive importance of radiographic progression-free survival (rPFS) for overall survival in this setting.

Transcript

Could Lynparza’s approval in mCRPC in the first-line setting translate to fewer unnecessary tests?

PROpel has demonstrated that HRRm [mutation] testing is not necessary to identify patients who may derive benefit from the combination of olaparib and abiraterone [Lynparza]. This said, testing remains clinically important for prognostic and familial risk purposes. That will be really something important to discuss in the future and to see with the patients also what their expectation is. But it is not expected to be required based on the PROpel data to have HRRm testing to decide on the treatments. It’s more for prognostic and familial readings.

Will providers want to see overall survival data or wait longer before Lynparza becomes widely accepted?

Overall survival [OS] is a very important end point, as it’s the gold standard at the end. That’s what we’re all aiming to achieve. Radiographic progression-free survival is used really as a primary end point in most trials in first-line metastatic castrate-resistant prostate cancer because we know OS can take time to assess, can be challenging sometimes also with multiple lines of treatments, and we don’t want to delay potential access to impactful medicine while waiting for OS. Radiographic progression-free survival is really an important point and is recognized as being predictive for OS in most cases.

So I think, looking at the benefits that we’ve seen with PROpel in rPFS and the very positive feedback as the longest median PFS observed in the setting, it’s probably going to be really important to focus on these end points to start with. We know that US data from PROpel are still immature; they will come at a later point, but for now they’re still immature. However, with that, we have been able to see positive trends. And I think it’s also important to remember is that we’ve reported some additional secondary end points, as second disease progression, which is a key secondary end point, which can in most cases predict OS benefits.

So, the positive trends that we see in OS are very reassuring. The strong median PFS that we see is also very reassuring, and as it’s all consistent between primary and secondary end points, we are relatively confident in these outcomes.