James Hu, MD, FACP, University of Southern California-Los Angeles, discusses the results of the ANNOUNCE Trial and challenges associated with treating sarcoma.

Transcript

James Hu: Hello. My name is James Hu, from University of Southern California, in Los Angeles. I am the sarcomatologist at USC. 

The ANNOUNCE trial was recently presented by Bill Tap and his co-investigators. Although it was a negative trial, it proved in sarcoma that you can do large randomized studies in a collaborative way, in a relatively rare tumor. Despite the fact that it was a negative trial, again, we learned a lot from this trial.

One of the things that we learned is that perhaps we need to homogenize the groups better. It seems that, a sarcoma typically is a very heterogeneous tumor, and therefore, you'd like to compare very light groups. I think the lesson from this trial is that we have to homogenize those groups a little bit better.

So, where do we go from here? I think what we've proven is that doxorubicin is still the standard of care. One of the interesting things about this study was that the control arm had a very long overall survival, which is about 19 months, which is really long in terms of sarcoma overall survival. This is a little bit of an outlier.

To be able to compare a drug to that long overall survival, the bar is raised somewhat, to try to prove a small difference. So what does that require? It's going to require that we identify better drugs, number one, and also to better homogenize our groups, as I mentioned.

A lot of discussion has been raised about how we're going to do that, how we're going to homogenize these two groups. One thought was to maybe just focus on one type of sarcoma, like a leiomyosarcoma or L-sarcomas. That's one way that we can do it. We can also do it by using some biomarkers.

However, in sarcoma, I can tell you that biomarkers are very few. We haven't identified one that universally identifies a particular subset as being homogeneous. So those are some of our challenges. I think as we go forward, future studies that might be of interest are immunotherapy, certainly in one of our phase II expansion studies using anti-PD-1 approach. One subset of sarcoma showed some benefit in terms of response, and hopefully, we can add that to the armamentarium of sarcoma therapy.