Olema Pharmaceuticals Stifel 2026 Healthcare Conference

We're very confident in the data we've generated to date, and it's a classic question that we have in oncology, which is, are you able to replicate that phase II data in the phase III setting? And obviously in Q1 for OPERA-01, the second line, second, third line study, we will have that readout. OPERA-02, which is the first line study with KISQALI, is enrolling extremely robustly.

Yeah. Why is that? One thing that you There are a couple reasons for it.

It is absolutely true that persevERA was a negative trial.

Right? It did not meet its hazard ratio. It didn't get its p-value. It is also absolutely true that there's evidence of activity in that trial, right? There are negative trials where you go, "Wow, this really doesn't do anything.

And to be perfectly honest, if that had been the result in persevERA, I think we would have some soul searching to do.

Five months is absolutely practice changing.

The challenge is that their hazard ratio missed by a few hundredths, actually. There is clear evidence of activity. Now, there is a design flaw in that trial, and the design flaw is including endocrine-resistant patients. If you look at their tables, that is the TFI treatment-free interval, less than 12 months. Those really aren't first-line patients. Those are endocrine-resistant patients, and they're treated actually as second-line patients in the practice guidelines. Where those patients come from is they received an adjuvant therapy, they stopped that adjuvant therapy, they then went on to develop metastatic disease, but that metastatic disease occurred within the first year of their completion. Those patients generally, as I said, are second line. We don't have those patients in OPERA-02. We never did from the beginning, actually almost no one, because of the treatment guidelines.

Yeah. One thing I think that you have to realize is that, first of all, our phase II data, one year in patients post-CDK4/6 progression, mostly wild type, 30% two prior CDK4/6s.

So our phase II data is compelling. The tolerability from that looks like KISQALI plus AI, so there is not a signal there that has people concerned about giving that combination. Then very simply, the control arm is the global standard of care.