Dr. Susan Galbraith

Then in Destiny Breast 09 at ASCO, we showed the data in the first line metastatic setting in combination with Pituzumab.

What Destiny Breast 11 does is now take this drug that's shown great efficacy in the metastatic setting and bring it into this early stage setting.

Patients who are newly diagnosed with early stage breast cancer

and take it into the neoadjuvant setting, which is where you treat patients with treatment regimens before they go for surgery.

And the importance of this is that these patients have potentially curative disease.

So the Destiny Rest 11 compared four cycles of NHER2, followed by four cycles of a three-drug regimen, THP, which has a taxane,

Herceptin and Pituzumab in it and compared that with the current standard of care or one of the current standards of care, a dose dense anthracycline and cyclophosphamide for four cycles, then followed by the THP.

So it's

It's up against a five drug regimen in that setting.

And the primary end point in Destiny Breast 11 was the pathologic complete response.

And the reason why that's important is we know if you can achieve a pathologic complete response, your five year overall survival outlook is greater than 95%.

So in the early stage of breast cancer, maximizing the opportunity for cure is the goal of treatment and getting to a pathologic complete response

is a good indicator that you're on route to that goal.

So we saw an 11% improvement in that pathologic complete response rate compared with standard of care, but also importantly, we actually showed an improved safety profile

with lower rates of grade three, four adverse events.

And it was a well-tolerated regimen overall, which is also clearly important for somebody that's being treated for curative intent.

And there was an early trend to improved event-free survival, very immature data on that.

So it was only an early trend, but nonetheless important to see.

So I think in order to answer that question, I think you have to take Destiny Breast 11 and Destiny Breast 05 as complementary studies.

The sizing of Destiny Breast 11