This panel featured:

Stephan A. Grupp, M.D., Ph.D., Section Chief of the Cellular Therapy and Transplant Section at Children’s Hospital of Philadelphia

Lori J. Pierce, M.D., FASTRO, FASCO, Chair of the American Society of Clinical Oncology Board of Directors, Professor and Vice Provost for Academic and Faculty Affairs, University of Michigan.

Peter Pisters, M.D., President of The University of Texas MD Anderson Cancer Center

Moderated by – Steven T. Rosen, M.D., Medical Oncologist and Hematologist; Provost and Chief Scientific Officer; Irell and Manella Cancer Center Director’s Distinguished Chair; Morgan & Helen Chu Director’s Chair of the Beckman Research Institute.

If you were unable to tune in live to this panel, you can watch it here.

Dr. von Eschenbach: Welcome back. If you can please take your seats. Looking forward to the next panel around some of the clinical advances that have been made over the past 50 years by virtue of the National Cancer Act. You know, as a former NCI director, you know that one of your greatest assets and some of your best friends are those heroes who agree to become cancer center directors, because they have to deal with the complexity of everything from supporting basic research on one end of the spectrum all the way to the other end of the spectrum with regard to training, clinical research, cancer prevention, etc. So being a director is a challenge.

And we’re very fortunate today to have with us to chair this next panel, Dr. Steven Rosen who was, for 24 years, the director of the Robert H. Lurie Comprehensive Cancer Center at Northwestern, and now is serving as the head of the cancer center and the Beckman Research Institute of City of Hope. He has a distinguished career as a medical oncologist, and particularly addressing himself now to much of the academic progress that’s being made, having published over 400 articles himself. And is currently the editor-in-chief of the textbook series, “Cancer Treatment & Research.”

So we’re very fortunate to have him lead this conversation as it relates to the progress that’s occurred in the clinical care of patients. And he’ll introduce his distinguished panel. Steve, thank you for being willing to do this.

Dr. Rosen: Thank you, Andy. Good morning, everyone. Welcome. We have three renowned panelists. They’re all experts in the field, thought leaders, each of distinct area. I’m gonna introduce them briefly and then I’m gonna ask them to answer a series of questions. Then we’re gonna open it to the audience, and hopefully have a thoughtful period of communication about all the issues that we’re dealing with.

So, first, I’m gonna introduce Dr. Peter Pisters. Peter is the president of the University of Texas MD Anderson Center. He’s a surgical oncologist specializing in sarcomas and gastrointestinal cancers, and has received numerous outstanding teaching awards at the institution. Thank you, Peter. Dr. Lori Pierce is the vice provost of academic and faculty affairs at the University of Michigan. Lori is a radiation oncologist, distinguished figure at breast cancer research, a member of the National Academy of Medicine, and the 57th president of the American Society of Clinical Oncology. Welcome, Lori.

And Dr. Stephen [SP] Grupp, the director of the cancer therapy program, and medical director of the cell and gene therapy laboratory at Children’s Hospital of Philadelphia. Steve is a pediatric oncologist and leading figure in cancer immunotherapeutics. Please join me in welcoming this very distinguished group. So, the first question for you, what do you feel is the most profound legacy of the National Cancer Act? We’ll start with you, Peter, and go to Lori.

Dr. Pisters: Well, that’s the topic of the whole session in many ways. I think probably, among the many contributions that we all see now, and are discussing, is the ability to bring clinicians and researchers together in synergistic ways that nobody even imagined at the time, that it created opportunities for discovery, that brought clinicians and researchers together to understand common problems. And then to create solutions that we’re now seeing, and are benefiting patients and saving lives. And I think it’s really took a cancer research from an obscure area to a coordinated national effort, and we’re really seeing 50 years of progress as a result.

Dr. Rosen: Do you have one example in your mind that would lend itself to this teamwork?

Dr. Pisters: Well, I think a lot of the work that we’ve seen in targeted therapies, for example, where you’re understanding the molecular basis for cancer, you’re understanding potential targets, and you’re developing drugs against those targets. And then moving an entire field forward that we now know as targeted therapy, is an excellent example.

Dr. Rosen: Lori?

Dr. Pierce: So, I can answer this in a very general way and a very specific way. So I’ll do the general. I think about what I do every day when I see patients. And I’m a breast cancer radiation oncologist, so I see Mrs. Smith. And I can take the imaging information, I can take the genomic information, I can take the clinical information, and then derive a treatment recommendation, individualized, based upon Mrs. Smith’s tumor. That is all possible because of the National Cancer Act. Everything we do is so different. And because of the National Cancer Act. We think about 50 years ago. It was a one-size-fits-all, and now we can individualize. We do based upon the specifics of Mrs. Smith’s cancer.

And then from a specific perspective, I think it would be the creation of the national clinical trials network. Clinical trials change everything. That’s how we move the needle. That’s how we improve what we do for patients. Taking care of patients, offering them the best therapy, that they are North Star, that is what we aspire to be able to offer patients the best possible treatment.

With clinical trials, you can take a therapy derived similar to what we heard in the first panel, and process that through phase 1 trials to try to find the best dose, phase 2, and then phase 3, and be able to compare these new therapies to whatever the standard of care is. And that is how we move the needle. That’s how we improve treatment. So I think this is all absolutely possible because of the advances of the National Cancer Act.

Dr. Rosen: Steve?

Dr. Grupp: Yeah. I think the first session was so fascinating for me. And what I see is, again, the theme of bringing everything together. You know, often NASA tries to justify some of what it does by saying, “Look at all this cool technology that’s fallen out of the space program,” which, as a space geek, I think is the greatest thing in the world. But multiply that by 10,000 for the Cancer Act.

And I think that bringing all these folks together, all of this basic science, I mean, looking at Dr. Baltimore talking about reverse transcriptase, realizing that you need a reverse transcriptase in order to make the thing that I work with, which is a chimeric antigen receptor, or CAR Ts actually work, thinking that you can understand the virology of HIV, cripple HIV, repurpose HIV, and then actually make T-cells do what they want. We heard Dr. Allison talking about waking up T-cells for their natural ability to kill tumor cells, and then we reprogram T-cells to force them to be able to kill tumor cells. All of these are completely unexpected technologies that came out of basic science research, handed off to the clinical programs.

And then the thing that excites me most at this moment, in addition to being able to provide transformational therapies to patients, is we’ve talked about “bench to bedside.” And that’s our mantra, and that’s what we all want to do. But now there’s “bedside to bench.” So you have these patients, kids in our hospital who are having these transforming responses to brand-new fields of medicine, whether it’s immunotherapy with checkpoint inhibitors, or in our case, with CAR T, or with many, many other therapies.

And then you can take their cells right back to the lab, with incredible techniques developed by the basic scientists to interrogate actually what’s happening, so you can understand these things in a rapid, iterative fashion, none of which would have been possible without this infrastructure and focus on cancer.

Dr. Rosen: I also think the speed of development now is just astounding. Dan Von Hoff, who’s a colleague, a renowned clinical investigator, would often say that to a cancer patient, weight is a four-letter word. And we’re now at a point where we actually find that we can bring therapies to patients in a reasonable period of time, that didn’t exist in the past, with the anticipation therapy is gonna work. Next question. Within your area of expertise, what do you feel are the most significant advances over the last 50 years? Maybe we’ll start with you, Steve, on this one.

Dr. Grupp: All right. Given a certain level of bias, you know, I think that immunotherapy is incredibly exciting. Of course, it’s new, it’s relatively new within the context of 50 years of development. But just the idea that we may actually…and Dr. Allison touched on this briefly, may actually be able to go chemo-free for so many more of our patients, and spare them…my own experience with lymphoma therapy, and I would have liked to avoid the chemotherapy. And the notion that, in the future, we could possibly do that for our patients is incredibly exciting. And I think that both sides of the immunotherapy axis provide that potential.

You know, I remember hearing early on from mentors that, why are you thinking about the immune system and cancer? They have nothing to do with each other. And, of course, they have profound things to do with each other. So that recognition that T cells especially, but other immune cells can actually have an impact, is, I think, one of the more important discoveries.

Dr. Rosen: Lori?

Dr. Pierce: So, I’m wearing my radiation oncology hat. I’m thinking 50 years ago, I would assume everything was cobalt, and a field from the front and the field from the back. Fast forward to now, how we have advanced to the point that we have linear accelerators, we can vary the beam arrangements, we can vary the intensity of the arrangements. We can do IMRT, intensity-modulated radiation. We have radioligands where you can take a compound and target it specifically to a tumor, and then give the radiation directly to that tumor.

Looking at the biology side of things, being able to understand the biology of the tumors, assessing what genes make them radioresistant, and then combining it with systemic therapies which address those areas of radiation resistance. I mean, it’s just, it’s explosion of what we can do now with radiation compared to 50 years ago.

And then, I guess, wearing my breast cancer hat, going 50 years ago where I think the majority of women probably still would have been treated with a radical mastectomy. Then a modified radical mastectomy, and, of course, we now have lumpectomy and radiation, and we know that that gives the same survival as a mastectomy for patients with early-stage breast cancer. And we have subsequently learned, and this is all because of clinical trials, that radiation not only reduces the risk of local recurrence, but that actually that translates into a modest survival advantage.

And knowing from a systemic point of view, looking at HER2/neu, and looking at how trastuzumab and other trastuzumab-like therapies have now changed the natural history of HER2/neu-positive disease from a very untreatable cancer to a highly treatable cancer.

And then from a surgical perspective, looking at things like sentinel node surgery, and other aspects, also radiation, where we’re learning that sometimes less is more, that if we can assess the potential outcome from a certain cancer, that perhaps some of them don’t need to have radiation. And we can spare radiation for those. And for those that have a highly aggressive disease, that perhaps they need more radiation. And we’re learning now to be able to look at molecular profiles that help us to select those. So it’s changed significantly, both from a radiation perspective and from a breast cancer perspective.

Dr. Grupp: Actually, if I can, sort of, jump in very briefly on that, what I’m hearing between both of us is, hurt people less, and get better outcomes. And that is also extraordinary. So, of course, as a pediatrician, we got kids who got their whole lives ahead of them. And we want to make sure that those are healthy lives, and we see often that they aren’t. They’re survivors, which is fantastic, but they pay a price.

Dr. Rosen: Also, combining the technology with the biology is fascinating. That all comes together.

Dr. Pisters: It comes together beautifully in radiation, where you have the cancer biology, you have the physics, and then you have the clinic. And it all comes together.

Dr. Rosen: Peter?

Dr. Pisters: Well, I think, in many ways, what you’re hearing is part of the fusion of the forces of physics, engineering, and medicine. And that that has created proton therapy in the radiation oncology world, and has led to a minimally invasive robotic surgery, which, along the themes of less is more, has really helped to revolutionize surgery. And minimally invasive surgery has been applied to patients with cancer in very innovative ways, been combined with sentinel node therapy, which, in many ways, is a minimally invasive approach that takes into account biology and spread of disease. And these are advances that have had huge impact on patients over time, and that we see everyday today.

I think, looking into the future, among the things that we’ve been talking about, one thing that we should certainly focus on is cellular therapy, which is a brand-new field that’s just opening up now. And as we see, in the past, chemotherapeutic treatment has been largely infusions and pills, and now we’re moving into a brand-new era of genetically modified cells that are reinfused into patients. And that, I think, is going to be game-changing in many ways, where the product is not a pill, is not a compound injected into an IV fluid and infused into a patient, but it opens up a brand-new pathway for cancer treatment.

Dr. Rosen: And in blood cancers, we’re blessed that we’re leading that activity. You know, I have about 300 active patients now. I haven’t had a single death in three years, and maybe a handful have received chemotherapy. So all the modern biologic treatments is quite profound. And, actually, CAR T therapy has been a game changer in terms of what you can accomplish as some of the [inaudible 00:14:58] patients.

The next question for all of you, and this is very important one, how can we advance health equity and cancer prevention, and treatment, and survivorship? This has been an issue since I’ve been in training, and it seems like there’s a period of passion and then we just, sort of, start and stop. So maybe, Lori, this one, you’re happy to start with.

Dr. Pierce: So, I was honored to have been, as you said, the president of ASCO. And when you are voted as president, you have a year as president-elect, and you are asked to decide what your theme is gonna be. And I chose the theme of equity, and did it at a time before George Floyd, before the pandemic. And I wondered if this was going to be welcomed by the oncology community. Oh, my gosh. This was the time for a theme of equity. And I chose it at the time because, you know, we all are cancer people. And certainly as a minority oncologist, we’re all aware of the disparate outcomes for certain populations with cancer.

You know, you think of black males and prostate cancer, and over 100% increase in mortality rates compared to white males with prostate cancer. You think of black women with breast cancer, and 40% increase in mortality compared to white women with breast cancer. You think of Asians and Pacific Islanders having twice the incidence of gastric cancer as white Americans.

You think of Hispanic kids, adolescents having higher risk of leukemia compared to whites. You think of Native Americans having a higher incidence of GI cancers, liver cancers. And the list just goes on. And so I thought that equity would be the right decision. And during the year, we were able to put forward a lot of initiatives. ASCO already had many, and we increased that as well. And one of the things that we focused on was needing to increase a diverse workforce.

We all know that the number of minorities in oncology is woefully low, much less than the percent of the patients who minorities are people that we serve. And so we are working on a way to increase the pipeline, having more minority oncologists.

We are working on an initiative with ACCC, the Association of Community Cancer Centers, to increase minority participation in clinical trials. We already talked about how important clinical trials are. And if you look at the percentage of minorities in clinical trials, it’s roughly around 3% to 5%, and slightly higher for NCI trials, slightly lower for pharmaceutical company trials. It’s around 3% to 5%. And we know that that is the way to move the needle. And so many times, I’ve heard people say, “We just can’t get patients to go in clinical trials.” The problem is not the patient.

Dr. Grupp: Oh, yeah, you can.

Dr. Pierce: The problem is us. We need to create an infrastructure to remove the barriers that patients have and that institutions have so that patients can go on clinical trials. And so this initiative that I mentioned is to develop…we have a pilot looking at a tool that institutions can do a self-assessment and look at various stages for enrolling patients, and see where the barriers are. You see how many patients come into your cancer center, and yet you see how few are actually offered a clinical trial. What are the barriers that are presented preventing those patients from coming on board?

Because the bottom line is, if you look at many studies, including a very recent one by Agarwal [SP] et al., published in the “JNCI” last year, once you ask a cancer patient to go on study, whether they are white or black, the same percentage goes on study. It’s around 50% to 55%. It makes no difference what race they are. So we have to get things to the point that they are offered a clinical trial. And so that self-assessment study hopefully will open some eyes, because every institution has different barriers, and be able to see where the barriers are.

And then another initiative we’re working on is to increase awareness of the social determinants of health. You know, we know that a lot of the barriers that patients face are from the social determinants of health. And these factors are so important in terms of not only treatment for cancer, but also prevention. You know, we need things along the full continuum: prevention, screening, treatment, and survivorship. And if we can prevent a cancer, that’s better than having to treat a cancer. And so we’re working on increasing awareness of social determinants of health. And I applaud all the work that the NCI is doing, and we need all hands on deck for that. So, I can talk about this much longer, but I’ll stop.

Dr. Rosen: Peter?

Dr. Pisters: Well, I think it’s very symbolic that we’re really addressing this question at this session. And it really, I think, in my mind, symbolizes the fact that America is at a crossroads right now, driven by George Floyd, by so many things that are happening in our society. And you see corporate boards moving to ESG goals. You see institutions embracing DEI in their strategic plans, and you see a massive sea change occurring right in front of us. So I couldn’t personally be more excited about what we’re seeing. It creates real opportunities for us to come together as a community, to have impact, and to think about the importance of the policy issues that Lori was alluding to.

When we look at the important aspects of the social and behavioral determinants of health, and how they’re largely ignored over time, or the structural issues in American medicine, and health policy where, for whatever set of reasons and circumstances, insurance is linked to employment. That is a fundamental flaw that underpins many of the access challenges that we see in America right now, that is not a mistake that other developed countries have made. And that’s one of the reasons that health outcomes writ large in America, but do not rank anywhere in the top 10 in the world.

While we have unbelievable outcomes that we’re discussing now in oncology, when we look at other aspects of public health, longevity, so many aspects of things such as infant mortality rate, or maternal mortality during childbirth, we have a long way to go. And addressing these really will allow us to come together to focus on important policy issues in Washington that will really help to change the landscape for Americans.

Dr. Pierce: You know, if I could build on something that Peter said, you’re talking about policy issues, I think a great example is the Clinical Treatment Act. So, the Clinical Treatment Act, to give a little bit of background, for Medicare patients and private patients with private insurance, if they enrolled in a clinical trial, their routine care costs would be covered by their insurer. So seeing the doctor, getting antiemetics, getting X-rays, those kinds of charges were covered by the insurer. Medicaid, they were the only patients who didn’t have the routine care costs. These are the poorest patients. These are the patients who needed that cover, but that was a rock that had not been picked up.

And a lot of work by ASCO, by Friends of Cancer Research, by many groups said this has to change. And I’m very happy to say that as of January of 2022, it will change. Laws will pass. But this was a classic example of disadvantaging a population who needed the most. And the irony was that those particular charges were covered by Medicaid if people were not on a clinical trial. So it was a disincentive for the poorest patients, who are the ones who probably needed the most to go into clinical trial. So looking at policies, and taking the time to actually scrutinize policies that have been in place for a while, that probably need to be reassessed and changed. It’s so very important that we all do that.

Dr. Pisters: I just want to build on something Lori said that I think is very important, that those of us that are in the field and work in centers like MD Anderson or the University of Michigan, have a degree of cognitive dissonance around this access issue. And that leads to a degree of moral distress among those of us that are in elite institutions, who are well aware of these gaps, cannot do anything about it, and need to influence policy change in Washington about it.

When I talk to our faculty about our commitment to Harris County safety-net hospitals, and the clinic that we have at LBJ Hospital, they’re wildly enthusiastic about what we’re doing for the underserved in our own county. They’re raising their hands. And this is a reflection of the moral distress that’s present right now.

Dr. Rosen: Steve, your perspective as a pediatric oncologist…

Dr. Grupp: Yeah, as a pediatric oncologist. I think what I find myself thinking about over the last five years, as we were developing this whole new field of medicine, was access. And access and equity go so much hand in hand. When, you know, you look at these therapies that we’re talking about, I mean, the genetically engineered therapies are really being delivered, and quite appropriately at complex tertiary and quaternary care centers, which require travel. And maybe in the future they’ll be so safe that they won’t require that, but that ain’t today. That’s not the situation.

So, as an example, at our center, we treated our first CAR T patient in 2012, and almost immediately, we were able to secure philanthropic dollars that allowed us to pay for travel and hotel rooms for patients who are coming to us.

Now, that doesn’t relieve a lot of the problems, but at least it prevents it from being a filter for only people in the upper-income strata. And this is going to be more and more of a problem because on the one hand, I was incredibly excited to be part of the CAR T development process, getting the first product to FDA approval.

But at that moment, it became one of the highest single-cost therapeutics in medical history, and that may not be something that…even though we see the same pricing across the field, we’re talking about $300, $400, $500 for these genetically engineered products. How do people access that? Is that an appropriate price? I can’t say. I’m not a health economist, I can’t speak to that. You can talk about value and say that’s a value delivered, but is it actually going to be something we’re going to be able to do for the number of patients?

And you made the key point that this is really only working in blood cancer. And, forgive me for saying it this way, but God forbid it works in a more common solid tumor, because how are we gonna handle the costs? I mean, we want this desperately, but are we set up for it? Can we imagine what that’s gonna cost? And we know that cancer therapeutics, in general, are expensive, and healthcare in the United States is expensive, but this issue of equity and access is really something that we’re thinking about a lot.

And I will end with something we were talking about last night, which is a non-cancer example, which is sickle cell disease. And so, right now, there are at least two approaches to gene engineering stem cells to cure sickle cell disease, I believe. Of course, we don’t know, we need to follow these patients longer, that these are potentially curative therapies. They’re much less risky. They’re much easier to get than an allogeneic transplant, which is the thing that I do as a clinician most frequently.

And so we want to move to this safer autologous therapy. Those products are gonna cost over a million dollars a piece. In a medically underserved population, how can we possibly begin to treat the incidence population in that circumstance? Sure, that’s non-cancer, apologies to everybody, but this really illustrates the issue, I think, of equity and access for us, and for these high-cost, but extraordinarily transformational therapeutics.

Dr. Pisters: Steve, this is such a good point, and if you don’t mind me jumping in for a second. Just to point out that a part of the future has to be a push in science, a push in access, and a focus on cost. If we don’t focus on cost, we’re going to be developing therapies for the 1%. And that is something that we can’t let go of.

One of the most compelling piece of data that we talk about internally is the risk for personal bankruptcy associated with the diagnosis of cancer. And what we know from large Medicare datasets is that 43% of Americans will be personally bankrupt within 2 years of cancer diagnosis. And that is an absolute disaster. And it really means that if we’re not focused on the cost of care, we’re not going to be able to make advances at a societal level.

Dr. Pierce: So, if I can just make one more comment, and we’re talking about the cost. Again, if we can prevent cancer, that’s the most cost-effective way forward. And, you know, if you think about all the advances over the plus 50 years, a lot of them have to do with tobacco control. So, while we had the previous panel with Nobel laureates who are so, so important in terms of biology, we need to have a panel of Nobel laureates in terms of social sciences and prevention.

Dr. Rosen: And that would be [inaudible 00:28:45].

Dr. Pierce: Yeah. And so that we can be focusing on biology. At the same time, we focus on prevention. I mean, that’s really a way forward in terms of cost effectiveness.

Dr. Rosen: [Inaudible 00:28:54] who is one of the pioneers in tobacco sensation, always would tell the great story where he was at Sloan Kettering, everyone’s smoked. The tobacco industry was supporting aspects of Sloan Kettering at the time. And his mentor, actually, was smoking cigarettes. But he was looking at the impact of tobacco.

And he went to his mentor, who’s apparently a thoracic surgeon, and he showed this profound data. And he says, “We have to present [inaudible 00:29:18] when we meet up.” And he said, “Well, we’ll get through it.” And so [inaudible 00:29:21] said, “How do you know we’ll get through it?” He says, “Because we’re right.” And I’ll never forget that. And, obviously, it’s hard to believe that it took so long to appreciate the devastating aspects of tobacco use.

Before we leave this compelling issue, because it is maybe the most important at this moment, and it’s just so disheartening to think that 10 years from now, we may be discussing the same issue of health and equity. In the audience, we have one of the leading figures in America, Robert Winn, who has made a profound impact in this regard and, honestly, the most articulate and passionate ways. Rob, do you have anything to add, or is everything being covered?

Rob: I’ll just [inaudible 00:30:01] listening.

Dr. Pierce: No, no. You can do better than that.

Dr. Rosen: Yeah.

Rob: No. I got [inaudible 00:30:07]. We’re sitting at [inaudible 00:30:17].

Dr. Rosen: So, our next question is almost the antithesis in the sense that we’re now dealing with the COVID pandemic, something that no one was anticipating. And it’s had such a profound change in our institutions. And I would ask you one of the valuable lessons that we’ve learned that are relevant to cancer care, and what are the positive things in addition to recognizing the terrible scourge of the disease that have come out of this and changed the way you provide care for your patients? Maybe, Peter, we can start with you?

Dr. Pisters: Sure. Well, I see two macro forces that are worth discussing here. The first is the pivot to virtual care, which has been unbelievable, and hopefully permanent, in many ways, presuming that some of the regulatory and reimbursement issues are addressed definitively. This is cost-effective, patients love it, and it’s been integrated into our workflows. We’ve done over 300,000 virtual visits at MD Anderson. It’s been a spectacular success, and a silver lining in the pandemic without question.

The second area that I think is impactful is the work transformation associated with hybrid and remote work. I think, as we look at our own organization, we believe that this is going to be permanent. We have a work transformation team working on it. We believe it can create competitive advantage for us. We have a new acronym called WFA. That’s “work from anywhere.” And we realize that individuals can do roles like data science, and they can be in Cambridge, in Oxford, in Singapore, and work for MD Anderson. And we’re working aggressively in the work transformation, and we believe it will be permanent and very impactful for us.

Dr. Rosen: Lori.

Dr. Pierce: So, I agree with everything that Peter just said. I think, with regard to telemedicine and telehealth, there’s a lot that we need to learn for how best to optimize that. There are certain patient interactions that are very appropriate for telehealth. There are obviously some that are not. And so I think, over the next few months, and ASCO was looking at this very carefully, and other groups as well, just trying to optimize it. But we have to be able to know that it will be sustained, that that option will continue. That will be very important.

ASCO published a paper, “The Road to Recovery,” which actually looked at this very thing. As we eventually emerge from the pandemic, what can we take from it? What have we learned? And a couple of points, in addition to what Peter said, are that we need to make clinical trials more pragmatic.

And we shouldn’t have these boutique trials that, you know, everyone has to come into the main institution, which is usually in a city, to be able to get those trials. For patients to go on those trials, we should make them more pragmatic so that patients can enroll in trials in the community, because, of course, the majority of cancer patients are in the community.

Another point is that we need to somehow lessen the regulatory burdens. There’s a lot of regulatory…

Dr. Grupp: Please.

Dr. Pierce: I’m setting the stage for you. That was allowed during the pandemic. And we need to exploit that, go beyond, because you’d rather spend your time as a physician working with patients, not filling out forms for regulatory. So I’ll stop there, but there’s a lot that we can take.

Dr. Rosen: I’m old enough to remember the one-page informed consent where you can actually talk to the patient about it rather than the book that no one goes through.

Dr. Pierce: It’s very different.

Dr. Rosen: Steve, over to you.

Dr. Grupp: I would say the issue of the regulatory burden is an extraordinary one. I know patient protection is incredibly important, and much of what we are as clinical physicians dealing with, in terms of what we have to do in terms of regulation, is brought on by ourselves and our prior poor behavior. But the reality is that it’s so much harder…it took me a year to get my first CAR T-cell study open.

And, you know, I think we wanted to do two things with that. We wanted to learn how to use that. We could have done that in 20 patients. But we also wanted to give it to patients where we were seeing this transformational effect, now over 90% CR rates in relapsed leukemia. And for that, we expanded the trials. And it’s like, well, that’s not scientific. It’s like, well, I don’t care. It’s the only way we can actually deliver the therapy.

But getting back to the pandemic very briefly, and I know there’s not a lot of time, two points. One is, back to RNA. You know, we’re talking about reverse transcriptase. But now these mRNA vaccines, knowing that there was basically the design of the current mRNA vaccine a month into the pandemic, and that they got it up and going in the previous administration, in the time frame that they did, which was an extraordinary success. So, on the one hand, you have these amazing successes, and also same thing in terms of these new dedication to issues of equity, on the other hand, we have countervailing forces.

So, 85% of our patients come from outside our catchment area, and many of them, I’m facing the family, they have a kid with relapsed leukemia. They have no immune system. We have saved their child’s life. And it’s like, “Great. Here’s what we need to do.” And at the end of the conversation, I always say, “Hey, is everybody in the family vaccinated?” Thirty percent of the time, “No.”

And having that conversation without bringing anger and judgment is challenging. It’s possible, but it’s challenging. So, what do we do about that aspect? We’re talking about access, but we’re also talking about the lack of a shared understanding of what’s the appropriate thing under these circumstances. And that’s a challenge, I think, as well, that the pandemic has made completely clear.

Dr. Pisters: Can I just add one thing? When we look at what’s happened during the pandemic, it is a great advertisement for team-based science.

Dr. Pierce: Yes.

Dr. Pisters: When you can go from sequencing on January 6 to introduction of vaccine trials in the summer, and an approved vaccine being in arms in December, that is a result of team-based science. And while we want to respect and support curiosity-based basic science, exemplified by this morning session, Nobel laureates, we also want to highlight the benefits that are created when teams focus on goals that benefit society.

Dr. Rosen: Steve, did you have anything you want to add?

Dr. Grupp: Well, just the outcomes of team-based science, this is such a great point, are extraordinary, and it requires multiple people to be very good at the one thing that they do. But universities haven’t quite figured that out yet. And I think that if we want to propose big science and team-based science, then we have to get our universities to be able to value that.

Dr. Pierce: Can I just say, coincidentally, I’m a vice provost, just this past week, we put forward a proposal to have team science awarded for promotion. So your point’s well taken, at the University of Michigan.

Dr. Rosen: And I can say, as the provost, we take that into account now.

Dr. Pisters: We could get down a pathway here pretty quickly and [inaudible 00:37:36] tangent, but it really, really is, as you’re talking about, Steve, the promotion and tenure criteria in university and cancer center environments, to the extent that P&T criteria are really oriented towards individual outputs, we’re never going to have team-based science. As soon as we understand what criteria should be really rewarded, enhanced, and incentivized, we’re going to see teams come together and unbelievable things happening.

Dr. Rosen: So, the final question, moving forward, what do you feel is the most important issues related to cancer prevention, early detection, and/or clinical care in your mind? So, if you had the control of the resources the way you’d like, where would you put them?

Dr. Pisters: I’ll start.

Dr. Grupp: I have to go with my colleagues.

Dr. Rosen: We’ll start with you, Peter.

Dr. Pisters: Okay. Well, this was alluded to earlier today. I believe the biggest advances can be made by the fusion of data science and medicine right now. It’s an untapped area. It’s an area that we and others are really deeply investing in for really important reasons. We have terabytes of data. And I say all the time to our internal stakeholders at MD Anderson, the secrets to unlock the mysteries of cancer are hiding in our freezers and on our servers.

And it’s our job to find ways to unlock that. And that means bringing people to our teams that come from organizations like Facebook and Google, who are fed up with really finding ways to sell more socks and get more likes, and putting those people onto the cancer problem. And that, I think, is the next frontier as we see the fusion of mathematics and biology.

Dr. Rosen: Lori?

Dr. Pierce: I’m gonna say a similar thing in taking the biology, taking the social sciences, and putting them into clinical trials, and having a greater pipeline of patients in the clinical trials. Thanks to a lot of the work that my friend here, and the Friends of Cancer Research have done with ASCO, and FDA, and the NCI, of making the eligibility criteria less stringent so you can have more patients to go on clinical trials.

Clearly, that is the way of the future, having collaboration. I always say to my residents we’re seeing more and more “drop the mic” moments now. And it’s because we’re seeing more clinical trials, we’re seeing more advances, and we’re seeing more changes. And I think it’s all coming together extremely well.

Dr. Grupp: So, I’m gonna touch on two things. One is the clinical trial aspect. So, I don’t know what the current number is, somewhere around 3% to 5% of adult patients go on clinical trials, more than half of kids. Now, it’s a completely different circumstance. The staffing is completely different. I understand the differences. But I think there’s a way to have more access to clinical trials, and that may actually provide more opportunity for folks who may not have the means to necessarily get some of the most cutting-edge therapeutics.

The other aspect that I worry about, and, you know, I don’t want to end on this, because it’s the worst thing to end on, but cost is out of control. You know, we’re 18% to 19% of the U.S. economy. Are we gonna be 20%? Are we gonna be 25%? You know, can’t go on forever. And is there a way…as we learn how to deliver these therapies that are transformational and safer, and have fewer side effects, can we also have a way to leach a little bit of the cost out of the system because, you know, we’re heading toward a circumstance of not two, but three Americas.

We got the red America, and the blue America, and then the poor America. And the access in that circumstance are so different that, you know, I think that if we could address cost issues…you know, I’m in a high-cost institution, I’m not gonna say anything different. Of course. But that, I think, is something that I do worry about. So somebody has to go in a different direction because that’s not the positive way to look at it.

Dr. Rosen: Actually, I’m ending on a positive note. I would say that there’s not a single patient I see with the blood cancers I treat that I don’t think I can control the disease. That’s profound because 10 years ago, I would say there’s one or two options, and not knowing whether there would be a plan B. And now there’s always a plan B, a plan C, and it’s quite remarkable. We need to end the session. I see you patiently waiting there.

Male Speaker 1: I would like to open it up to audience Q&A. I know we had a discussion about doing that. And we’re gonna do that right now. Those of you that have a question, please raise your hand. I will come to you. But I do want to ask the first one. The title of this panel, “The National Cancer Act. Saving Lives from Hopelessness to Hope.” I’d like to go back to the National Cancer Act, specifically about therapies. There’s been a lot of talk about therapies. Can you tell us…sort of, touch on what the National Cancer Act has done to advance therapies? What was available 50 years ago? And what’s available today?

Dr. Rosen: So, maybe I’ll start. So, my little domain I mentioned now, just about every patient I take care of is doing well. No deaths. Back when I was a fellow, so this is 1979, and I was at one of the National Cancer Institute’s branches, the diseases we were focused on were lung cancer, myeloma, skin lymphomas.

And then other branches, obviously, were involved with other disease areas. In myeloma, there was one adequate drug. And you responded. If you didn’t respond, you’re dead. And the survival was two to three years. And now the majority of our patients are living more than a decade. And there’s so many drugs that it’s very hard to advance the new medication.

In lung cancer, the cell lines that were being developed by John Minna, Paul Bunn, and Des Carney back then led to all the profound observations now about the novel targets that we’re applying biologics to. So it took 20 years, but now we’re here, and it’s profoundly changed the way we treat lung cancer.

Male Speaker 1: Thank you very much. Our next question from this gentleman right here.

Jared: Hi. My name is Jared Rummler, and in 2003, I was diagnosed with stage 3 non-seminoma testicular cancer. I went through chemotherapy and an RPLND surgery at UCI. And I would just want to first thank the Nixon Foundation and Richard Nixon for the Cancer Act. I think that if it wasn’t for such an act, I probably wouldn’t be here today, and I wouldn’t have two beautiful daughters and my wife here. And thank you for the doctors and the nurses.

And I am in the exhibit here, if you get a chance to see that. Something I did want to ask is what have been the advancements in mental health for survivors? Is there anything being done to help people that have gone through being hurt by chemotherapy? And I’m so grateful to hear that we’re not going in a direction of chemotherapy. But what has been done in the past 50 years, and what could be done in the next for mental health for cancer survivors?

Dr. Rosen: Peter, would you like to initiate that discussion?

Dr. Pisters: Well, I certainly will. I’ll make a few general comments, and I think Lori’s probably closer to this with ASCO than I am. I think that in America, we’re going through a change, also, related to mental health, and people understand that mental health is part of health.

When all of us went to medical school, mental health and physical health were dichotomized. Patients with mental health issues were in a separate hospital. We just did a rotation over there and then forgot everything they taught us. And now what we’re seeing is that mental health issues are being destigmatized in our society. And we’re understanding that mental health issues are not a black-box issue anymore, that they have biologic causes, and that they can be treated with new targeted therapies, and that they can be approached with science.

And I think by destigmatizing mental health issues, we are really going to advance the overall welfare of Americans who all struggle at different points of their lives with mental health challenges. This is part of normal life, and that’s something that we have to help people to understand. It’s especially acute in cancer patients who’ve gone through a life-changing, life-threatening experience. And as we think about really reconfiguring survivorship, we’re doing you a disservice by not focusing on the mental health challenges associated with survivorship.

Dr. Pierce: So, I don’t have much to add, such a great response, other than to say that for many years, the focus on cancer therapies was on therapy and not survivorship. Now we’re in survivorship, but we need to look at mental health as a very important part of survivorship. And I think, again, social sciences, and asking the right questions, and looking at the biology of it all is very important focus of many of the trials currently ongoing.

I’ll also add that, in my comment before that we’re learning that less is more in some situations. Obviously, if you can avoid certain therapies, you will then avoid the mental health issues secondary to that therapy. So I think that’s another way of approaching such a very important issue. And thank you for bringing that up.

Dr. Rosen: Since the 1920s, the credence, City of Hope, that was advanced by a visionary, was that there’s no value in curing the disease if, at the same time, you destroy the soul. That’s on the gate, City of Hope.

Male Speaker 1: Our next question from your colleague, three rows back to your right, guys.

Rob: Just a quick question. Rob Winn, Cancer Center director at VCU Massey. Want to make a quick comment and then a question. I talk about progress, progress from 1971 to 2021. And I’m looking at the three of us sitting at this table, who are also cancer center directors, Dr. Ulrich, Dr. Ruben Mesa, and myself as actually that progress that gets made with the National Cancer Act.

So, as we’re thinking about also the science, we also have to take a moment to think about the greatness from that act that also allows us to sit as cancer center directors right now, bringing in different approaches, and actually focuses to the table of why I believe that the next 50 years really, the best is yet to come.

The question that I have is, learning from COVID, one of the things that I have learned specifically is that technology alone doesn’t get the shots in the arm. In fact, the science alone, and even the most brilliant science, this mRNA and all the rest of these things that we’re bringing to people are amazing, and yet we still have people who mistrust and distrust.

So the question that I have for you is, as we are looking at the benefits of the National Cancer Act and where we sit, as Eric Lander and I have been discussing, how do we rebuild and regain trust? Because in ’71, the magic was not only the science, not only the hope, but the trust of their communities. So, how are you looking in these next few years, or over the next 50 years of building that community trust, which we find out is also as important as things on the cellular level?

Dr. Rosen: So, first, Rob, I’m gonna address your first question, and now we have such great diversity. Believe it or not, when I started, now, you know, close to…what is it? Thirty-five years ago as a cancer director, I was the youngest in America. Now I think I may be the oldest. But I remember arriving and it was all older white male. I felt like it was the Soviet Politburo. It was such an unusual experience. And so the diversity is absolutely wonderful and a necessity.

But I think, getting to your point of how do you communicate these issues to different communities? You have to have people within those communities who can dialogue. It’s one thing for me to walk into a specific area and say, “This is what I think should be done,” when I have no particular relationship with the group, versus someone who everyone feels comfortable with, who they’ll trust. So I think it’s that sort of outreach that we need, having our advocacy teams.

Male Speaker 2: Back to the mental health issues. So, important as we talked about the impact of the National Cancer Act and the authorities he gave to the NCI was to be able to put survivorship into the agenda. And, fortunately, Peter, when I was at MD Anderson, we were able to start the sexual rehabilitation of the urologic cancer patient. And now I know you have programs that include yoga and meditation, and a variety of things that are supportive.

And we’re very grateful that you’ve been introduced to Melanie Eisenhower, a great-granddaughter of President Eisenhower and granddaughter of President Nixon, who’s devoting her career to exactly this same issue. She is at Children’s Hospital of Philadelphia in the radiology/oncology program, supporting children and their family to deal with the mental health consequences of cancer. So it is part of the benefits of that National Cancer Act, and an integral part of what you’re all doing at cancer centers and part of the agenda.

Dr. Pierce: Lori, you wanna make a statement?

Dr. Pierce: So, I just want to make one comment to Dr. Winn’s incredible, insightful question. And that is, and you alluded to this, we need a team approach. Everything can’t rest on the attending physician in terms of interacting, being able to answer all the patients’ questions, family questions, and going into the community. All those things are important, but it’s best done by a team.

And it may be that it’s not cost-effective to have these members of the team, and I think we have to make the case to our administrators that everything is not cost-effective, that these are things…at least not readily cost effective. These are things that will pay off the time, and that we need to have other members of the team, nurses, nurse practitioners, you know, other members of the team that can help us to interact with our communities.

Dr. Rosen: Steve, you got anything to add?

Dr. Grupp: And I just want to make a quick comment on the trust question, because what I feel like is, you know, as an older cishet, white guy, is that distrust is wholesale. There are societal forces that are driving distrust. Trust is retail. It is the individual interactions that we have with our patients. And those are the only effective tools that I have seen work in trying to convince folks who have hesitancy of one sort or another.

Trust in the physician, trust in the medical team, trust in the nurse practitioner, trust with the nurses, and then, of course, having a team that looks like the folks who are coming into the hospital, which is also incredibly important. But I think the only way we fix this is on a one-to-one level. I don’t know how we fix this on a societal level. That’s for other people to figure out.

Male Speaker 1: This could go on, and on, and on. And I wish it could, but we are running out of time. We have time for one last question then we’re gonna take a short break before coming back for lunch. So, our last question comes from Dr. Ellen Sigal. Dr. Ellen.

Dr. Sigal: So, thank you. This was a great panel. We talked a lot about clinical trials and the importance of getting them into the community. We didn’t talk about clinical trial transformation in good trials, and better trials, and trials that are more meaningful to patients. We learned a lot through warp speed how to really get these things done faster, better, but we still haven’t addressed good trials and the trials that are most meaningful, and what we need to do to get these trials so patients want to go on them.

Dr. Pisters: Maybe I can start and others can build on this. I think that there’s a dynamic tension that we have right now around clinical trials. On one hand, we want them to be pragmatic. On the other hand, we want them to be insightful from a biologic standpoint. And when you load the trial with biologic correlates, it gets complicated, and it can only be done in certain centers. And it, therefore, is non-pragmatic. If you make it pragmatic, then you lose the ability to gain very important insights on the underlying biology. That’s the first point.

I think we also need to spend time looking at the complexity of phase 3 designs, how expensive it is to do these trials, and look at the opportunity for things like synthetic cohorts to create a single-arm design, a digital cohort that can be completely matched to the trial cohort and reduce the cost of the time for real insights on new therapies.

Dr. Rosen: [Inaudible 00:54:46].

Dr. Grupp: Yeah. I think that the clinical trial approach that we’re using has created a large part of the success that we have at this moment, and it’s, kind of, breaking down because, you know, if you look at any regulatory packet, it doesn’t matter what the area is, and you have them in your bookshelf, in paper, they get thicker, and thicker, and thicker, and thicker over time.

And at some point, we get to a point where we really can’t do the work. And, you know, I think that what we get to is only a quaternary care center can have the staff that actually makes that possible. And we need to democratize clinical trials, we need to make it easier to be on clinical trials.

You know, the Affordable Care Act says that insurance companies are responsible for paying for clinical costs. They’re incident to participation on a clinical trial. We need to make that clear. The insurance companies are part of the issue as well. But in the end, we know, over and over again, patients who are on clinical trials get better outcomes, and that’s the most compelling reason to have.

Dr. Pierce: This sounds like a great topic to have a group discussion at the NCI with physicians and leaders in cancer nationally to really, kind of, rethink all of the compelling issues around clinical trials, and how can we achieve…probably can’t achieve everything, but how can we achieve the majority of things? Because there is clearly work that can be done to improve our clinical trial process. No question about it.

Dr. Rosen: I just joined the board of the Rising Tide Foundation which is out of Switzerland, and they have quite a bit of money. And they’re investing in trials that patients are interested in, and the patients want to put their input into, and with sort of real-time patient monitoring. We’ll see how that goes, but it’s a different way of thinking about the trial development.

Male Speaker 1: Ladies and gentlemen, let’s thank our distinguished panelists.