Promising Treatment Options for African American Men with Advanced Prostate Cancer Recorded on: May 29, 2012 David Ian Quinn, MBBS, PhD, FRACP Medical Director Norris Cancer Hospital and Clinics Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. ThatвЂ™s how youвЂ™ll get care thatвЂ™s most appropriate for you. Introduction: African American men are disproportionately affected by prostate cancer, and their death rate is higher than Caucasians. Dr. David Ian Quinn led an analysis of how African American men with metastatic castrate-resistant prostate cancer responded to a new active immunotherapy, Provenge (sipuleucel-T). An analysis of three phase III trials, presented at the 2012 meeting of the American Urological Associate (AUA), confirmed that African American men responded to the вЂњanti-cancer vaccineвЂќ and suggested they might even do better with it than Caucasians. Question: What does your data analysis show regarding African American men with advanced prostate cancer and their overall survival? Dr. Quinn: So, active cellular immunotherapy, something called sipuleucel-T or with a brand name Provenge, is a relatively new therapy. WeвЂ™ve had it approved for almost two years. And weвЂ™re now looking at the data that has been accumulated over a series of trials to see whether there are particular patients who might benefit more or less from the therapy. And from that perspective the analysis that we have presented here at the AUA (American Urological Association) meeting in Atlanta looks at a variety of different things, most particularly how African American men do with this treatment compared to other patients. Now, the finding that is salient to this is that African American patients seem to benefit at least as much and probably more as a subset from having immunotherapy for their advanced metastatic prostate cancer than Caucasian men who are the predominant people who went on the trial. What is in this particular presentation is an attempt to look at why African American men do better, and in that regard we have some parameters of immune response in those patients that weвЂ™re examining that are as good and potentially better than we see in Caucasian men. WeвЂ™re not exactly sure why this occurs. African American men may have an immune system thatвЂ™s better attuned to this therapy and therefore may do better and have a slightly better immune response. Or there may have been a selection in the trials so that the African American men that opted to go on this trial and the other trials that were analyzed looking at this therapy may actually have done so because they selected themselves out to go on that therapy. They may have had a better understanding of their disease, they may have been more amenable to the trial, and that may have meant that theyвЂ™re better than the average Joe that would have gone on. But I think these data are interesting and hopefully represent some good news for the African American population with prostate cancer. Question: What are the benefits of this treatment for African American men? Dr. Quinn: I think what it means for African American men is that the newer therapies that are coming to prostate cancer are a benefit to them, and thereвЂ™s always this doubt. Getting African American men to go into clinical trials is a challenge. ThereвЂ™s a lamentable history in this country with whatвЂ™s occurred with medical research and what I would describe as experimentation in African Americans, and certainly our African American friends are very well educated as to that, and from that perspective getting the African American population to be involved in trials is a major challenge and one that weвЂ™re trying to address at USC as well as at other centers around the country. But from that perspective, African American patients will come to us and say, well, look, IвЂ™m different to you. I have a different colored skin, my metabolism might be different, my cancer might be different. It certainly seems like itвЂ™s more aggressive than what a white guy gets. And IвЂ™ll say yeah. Then IвЂ™ll say, well, how do African American patients do on this therapy, and from that perspective weвЂ™re now able to say to them, look, youвЂ™ll do as well as the white guy, and the good news is that your immune system or something may mean that you do better, and itвЂ™s worth В© 2012 Patient Power, LLC 2 therefore you trying this because you have a disease that has reached a certain stage where itвЂ™s going to be fatal, and this has the opportunity to extend your survival. Question: How could this change the overall treatment approach for African American with castrate-resistant prostate cancer? Dr. Quinn: For the patients with metastatic castrate-resistant prostate cancer we now have a plethora of new drugs. Active cellular immunotherapy, of which Provenge (sipuleucel-T) is the first product and hopefully not the last immunotherapy that weвЂ™ll have, should be given early in the course of the disease. ThereвЂ™s a window where we need to give it to men early, very soon after they develop castrate-resistant prostate cancer for them to get a benefit. The reason for this is that immunotherapy is a little bit different. It doesnвЂ™t produce an instantaneous result, and its results in an individual patient can be difficult to meter. For example very few patients get any sort of PSA response or change when we give them Provenge (sipuleucel-T) therapy. But what we know is that after theyвЂ™ve had the therapy, which is priming the immune systemвЂ”itвЂ™s sort of like a vaccineвЂ”that the longer they survive after that, survivals after one and two years, they start to benefit with an extension in their survival. And we will see other data in the next few weeks about selecting patients early in their castrate-resistant disease to go on this therapy where the benefit may be maximized. Question: What are some other promising therapies? Dr. Quinn: Having seen this data related to Provenge (sipuleucel-T) weвЂ™re now looking in the Southwest Oncology Group to examine patients who have gone on a series of trials over the last 20 years with whatвЂ™s called SWOG, Southwest Oncology Group, to look at response, and it appears that African American patients may actually do a little better than their White colleagues with chemotherapy as well. Now, we need to look at that and place it in the context of initial hormone therapy, androgen deprivation, to see whether theyвЂ™re benefitting in particular ways, and this will allow us to refine the therapy. The data from a series of newer agents is going to be very interesting. WeвЂ™re waiting on data with a new hormonal agent called ZYTIGA (abiraterone acetate) in African American patients, and my В© 2012 Patient Power, LLC 3 understanding is that we will not see that here, but in the next few months weвЂ™ll see that. And with a new drug called Medivation 3100, a new hormonal agent also, we will see some data. There is a liquid radiation called Alpharadin (radium-223 chloride). WeвЂ™ve seen the first of those results early in this year, 2012, and weвЂ™ll see more data in the next few weeks on that. Unfortunately, that study accrued mainly in Europe because we were slow to get it started here and the Europeans realized it had great potential and therefore not too many African Americans or in fact other minorities outside of Caucasian folks went on that. But thatвЂ™s a very powerful therapy directed at one part of the bone metastasis and cancer that lies within that. And I think from that perspective weвЂ™re going to be looking to move these therapies forward and toвЂ”as they get registered with the FDAвЂ”look at the experience in minorities to see whether thereвЂ™s good effect. We think there will be, thereвЂ™s no reason why there shouldnвЂ™t be, but also to look at the side effects and how theyвЂ™re tolerated and whether thereвЂ™s an issue with durability of the response as well in not just African American patients but also Hispanics and in Asian Americans. Question: Are you encouraged? Dr. Quinn: Absolutely. I think weвЂ™ve learned a lot in the last certainly three years but I think in the last decade. What weвЂ™re seeing now is the result of investment from the research community, from NCI (National Cancer Institute), from a series of pharmaceutical companies, and weвЂ™re starting to get new treatments. What we need to do now is to work out the sequence and combination of these treatments and whether there are particular individuals that might benefit from one of these treatments or from all of them or from none of them and to look at new strategies. And I think we need to cut up our research that weвЂ™ve invested in and try to look for patterns. The other issue relates to how we apply our research, and I think that we have a commitment at USC and at the Southwest Oncology Group that the research we do needs to be applicable and available right across the spectrum of our community. And our focus in this presentation that we have here at AUA (American Urological Association) is obviously African American patients. If we look at the socioeconomic levels in this country, we know that the educated patients and the ones that have means are the ones that are doing well, regardless of the ethnicity, will access these therapies, and they will be, in quotes, early adopters. What we need to do is to make sure that right down in what we call the sixth and seventh echelons of socioeconomic level we make this available, and so weвЂ™ve made some decisions at USC where we have two clinical facilities. We have the Norris Cancer Center where we see predominantly В© 2012 Patient Power, LLC 4 patients that have insurance and Medicare, and then the largest indigent population in California at the Los Angeles County USC Medical Center. And the Norris (USC Norris Comprehensive Cancer Center) and Keck (Keck Medical Center of USC) hospitals have made the decision that we will offer Provenge (sipuleucel-T) therapy to appropriate patients who would otherwise not be able to access it within the Los Angeles County system. And weвЂ™re working with the company that makes Provenge (sipuleucel-T) to ensure that thatвЂ™s accessible for them at zero cost and that we try and get the benefit of the last three to 10 years research to everybody in the community, not just those who can pay for it. Question: Is this a more hopeful time? Dr. Quinn: Yes. I think it is a very hopeful time. ItвЂ™s a very positive time. WeвЂ™ve had a lot of developments in a very short time, and that challenges those of us who are in medical research. And what IвЂ™d say is that we need to work out the optimal application of these drugs. WeвЂ™ve done a series of probably between 12 and 20 critical trials, and weвЂ™ve had great support from patients. We really need to be very respectful that weвЂ™ve done this at the end of the prostate cancer spectrum and that most of the patients who went on those trials are dead, and so weвЂ™ve been batting at the end. And I would encourage patients to look at trials that offer these therapies earlier, particularly immunotherapy where the longer you get vaccinated for and the longer youвЂ™re alive with that immunotherapy response in your immune system working against your cancer, likely the better you do. I would encourage patients to consider those trials carefully and to try and be involved in as much as they can. We also do ancillary trials looking at peopleвЂ™s cancer and also their immune system and other factors that teach us a lot. And what weвЂ™re going to see now is some of those data come through and inform us about where we should be going with the therapies. And I think thatвЂ™s the real hope. At the moment we get trials that extend life by a few months at the end. ThatвЂ™s very important, I think provides quality time for those patients. If we can get things moving a little earlier then we continue on the pathway of maximizing that and also providing a hope for cure. Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. ThatвЂ™s how youвЂ™ll get care thatвЂ™s most appropriate for you. В© 2012 Patient Power, LLC 5