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IMPaCT Investigator Highlights (Text Version) - Dr. Tomasz Beer, Dr. Elisabeth I. Heath, Dr. Celestia S. Higano, and Dr. Howard I. Scher

Title: Prostate Cancer Clinical Trials Consortium: Bringing the "Best of the Best" to Prostate Cancer Patients

Tomasz Beer, MD, FACP, Oregon Health and Sciences University: There is no other organization in the country that has accelerated research in one disease as—as much as the Prostate Cancer Clinical Trials Consortium has. It has shown us how to get institutions that are large, ambitious, and generally have worked on their own in the past—how to get them working together and not just working together but being passionate about working together. That’s what the PCRP has done.

The PCRP is truly unique in accelerating moving drugs from the laboratory into patients and making a difference. And we’re seeing now in this last year, we had two drugs approved for advanced prostate cancer that improved survival. We’ve gone from one to three drugs that can improve survival. We have another one before the FDA that the consortium was heavily involved in that many of us expect will get approved, and more drugs in Phase 3 studies than ever before, so we’ve gone from a disease that was virtually untreatable to having multiple treatment options that can extend the life of patients with advanced prostate cancer. And we’re seeing that kind of progress just in the last couple of years.

Celestia S. Higano, MD, University of Washington Fred Hutchinson Cancer Research Cancer: One of the projects that shows what we contribute as a member of the consortium relates to the development of an agent called IMCA12, which is an IGF-1 receptor inhibitor. Our scientists have done a lot of preclinical work with this agent and we actually did the so-called first in human Phase 1 trial where we gave the antibody for the very first time.

So our institution did that within the consortium; we did the Phase 2 study of this agent in a very specific population of prostate cancer patients. We then went on in conjunction with the University of Michigan, Maha Hussain’s group, and spearheaded a trial looking at this agent in combination with a chemotherapy drug. And now again going back to that science that came out of our institution, we’re doing a trial in a cooperative group, the Southwest Oncology Group looking at hormonal therapy with or without this IMCA12 or cixutumumab drug. So I think you know that kind of shows how you as a member of the consortium can take something that’s early in the drug development, bring it through to a late-stage treatment, and design trials actually based on the science at your own place.

Howard I. Scher, MD, Sidney Kimmel Center for Prostate and Urologic Cancers Memorial Sloan-Kettering: The amount of work that it takes to bring a trial to fruition is enormous. The beauty of this group is not only does it streamline the process, but with the underpinning of the scientists you’re starting to think about the questions you will need to answer 3 or 4 years hence. And as everything is running in parallel, they’ve already done the work so my trial can be written now. And that’s in fact exactly what’s happening.

A total of 133 concepts have been submitted for review in a little bit over a 5-year period. We’ve approved 106; we’ve activated 84; we’ve actually completed 48 studies. I’m thinking now as somebody who is getting older, I want to work on things that will go all the way through. When the sponsors align and each group does what they do best, the trials can go like wildfire.

Elisabeth I. Heath, MD, Karmanos Cancer Institute Wayne State University: Detroit is a predominantly high African American population so as we have heard at multiple meetings, there is a health disparity that I see every day in my patients. Having the opportunity to take newer drugs, the best of the best if you will, to our patients in Detroit who are already at high-risk, have higher morbidity, higher mortality—that is an opportunity that’s unparalleled.

The number one thing I get asked is—what happens if this fails? Patients want to know that you have a plan from A to Z. And that’s a critical part, and being part of the consortium allows that because we have trials everywhere. And so when patients get a sense of that road map, they feel much more confident about their own disease and can empower themselves in figuring out where they want to go. And I think that’s a critical part for their overall well-being.

Scher: So the beauty of the program is not only its diversity but how it focuses on critical questions—ones that are not typically asked by funding agencies, but are really relevant to the end-game which is how do we help patients.

Higano: Everybody has their own personalities and their work styles. But at the end of the day despite its challenges, I think we’ve all been very gratified being part of the consortium because of the product at the end of the day.

Heath: We get to sit with 12 other major centers dedicated to prostate cancer research and share our ideas for translation of new drugs, new concepts and also to participate in the most cutting-edge clinical trials—terrific opportunity.

Beer: This is certainly not the only answer to the prostate cancer problem. There are many, many approaches but I think the theme is one of really drilling down to better understand what the right therapeutic targets are and in the next generation individualizing that potentially to each individual patient by studying their own cancer—that’s where I think the future is taking us and that’s the kind of work that we’re seeing really across the centers supported by the PCRP.

Scher: Typically when I talk to my friends and say you know one of our major supporters is the Department of Defense and get a reaction like why is that. And when you start to explain it and the scope of the program they go wow.

When you look at the range of topics that are conducted from biological warfare to tuberous sclerosis to various cancers, I obviously don’t have direct knowledge of those other programs but if they’re anything like what’s going on in the prostate cancer field it’s staggering.