Transcript:Robert A. Figlin, MD: Before we end this discussion, I’d like to start to my left with Tom and get some final thoughts from each of the panel members. Tom, you have the floor.

Thomas Hutson, DO, PharmD: Thank you. It was great to be involved with you all and to learn from you, and it’s an exciting time for us as treating doctors of kidney cancer patients. It’s exciting for the patients. We have more and more therapies. One of the concerns I have is that we continue to push the bar forward and refer for clinical trials. I’m concerned with new therapies out there. We have so many questions that need to be answered. The only way we can answer them is to try to continue to encourage the referrals on to our clinical trials and that we, as leaders in the field actually be smart as we conduct the trials. We make sure that we use our very valuable patient resources wisely.

Robert A. Figlin, MD: Dan?

Daniel J. George, MD: I think in kidney cancer, we’re really blessed to have all these different treatments for these patients. That’s wonderful, and there’s certainly a huge need to do trials. There’s an important need to study the drugs we have and to understand how to do this better. Some people look at that as post marketing, that’s phase IV trials. That’s incredibly important in this field, that we understand these value questions, we understand these survivorship issues, we understand biomarkers and selection strategies and how to be smarter about this portfolio of treatment that we have. It’s going to be harder and harder for community oncologists to keep up with what’s happening in kidney cancer with all the drugs and changes. We need to be partnering with you in how we do this, so that referral base goes both ways in terms of communication. And I think, in terms of understanding community needs, we need more registry work, more observational data that really understands what are the unmet needs in the non—clinical trial patients that are not being addressed with this current portfolio.

Elizabeth R. Plimack, MD, MS: Yes, absolutely. I agree with Tom that until we cure this disease, we need to continue to find new things, put people on trials and develop trials that are meaningful for patients, and to answer scientific questions. One opportunity I think we might be missing is immunotherapy after prior immunotherapy. There’s really a paucity of trials looking at immunotherapeutic approaches for patients who’ve had any immunotherapy prior. I don’t think there’s any scientific reason that we would expect that a different immunotherapeutic approach wouldn’t work for someone who’s been treated with that before. We just talked about VEGF after VEGF after VEGF, and we’ve made progress that way. We should really look towards that in the immunotherapy realm, as well.

Robert A. Figlin, MD: Nizar?

Nizar M. Tannir, MD: Thank you for the opportunity to be here with this esteemed panel, lively exchange. I would like to conclude with several pleas. I agree with what was said about the need to continue clinical trials. Let’s not forget, with all the excitement and all the progress we’ve made the last decade, a majority of the patients are not going to be cured even with dual blockade of immune checkpoints. Only 40% will benefit, and you have 60% who will not benefit. So, there’s really an urgent need to identify new targets and then develop new therapies. That’s really the first plea: to please continue having the work, science, industry, and academia come together to push the field forward so that we will have a world free of cancer and certainly a world free of renal cell cancer.

The second plea is we have drugs that are good drugs. We need to understand them better, and I think there is an urgent unmet need of predictive biomarkers. We touched upon that. There’s no predictive biomarker yet whether you’re looking at IOs or targeted agents. We don’t know who are the patients who benefit. Unlike the lung cancer colleagues where there may be a predictive biomarker for using a PD-1 there, we still do not have that. We really need to give the drug or the therapy to the group of patients we think are going to benefit and respond.

The third plea is we have responsibility as leaders in the field towards our taxpayers and society. Cost has to come into the discussion, and we really need to decide and put a value—and I know you recently wrote an editorial about this value thing. This is important. If we have a therapy, we need to look at the value. Does the drug provide a cure? Is there level 1 evidence for its efficacy? Is it tolerable? And what is the cost to society? So, we need to look at that. Insurers are going to demand that.

Robert A. Figlin, MD: David, thoughts?

David F. McDermott, MD: I agree with my colleagues. I think we owe a debt of gratitude to community oncologists presenting us the patients that have allowed us to complete these trials. And to echo what Nizar was saying about as far as adding value, the biggest place we can continue to partner with them to add value to our patients is to execute these adjuvant clinical trials that are getting started. They’ll be widely available around the country. Patients can go on almost regardless of where they live; multiple trials, multiple centers. If you look at the melanoma experience with immune checkpoint blockade, with ipilimumab, there was a 25% reduction in improvement in disease-free survival in those patients who got CTLA4 in the adjuvant setting.

Not to say we’re going to get a similar result, but a similar result in kidney cancer would make a huge impact in outcomes, in cost, morbidity, and improvement in quality of life. I think we can do that together; we certainly can test these drugs. The PD-1, PD-L1 drugs are the perfect drugs to test in the adjuvant setting given their toxicity profile. And we absolutely can’t do these trials without referrals, so the patients have to come. Hopefully, our partners in the community will send them for these trials and this will continue to make a big impact in this disease.

Robert A. Figlin, MD: One final comment from my perspective is to thank the patients. I remember at the beginning of this journey, many years ago, when many corporate sponsors did not believe they could ask and answer questions in kidney cancer. The patients were too diverse, diffuse. Most doctors only saw a few of them. There weren’t really any centers across the country that were specializing in kidney cancer. And it seemed like a question that they would be unable to ask and answer. The reality is, through organizations like our own academic institutions, key opinion leaders, industry and corporate sponsorships, but mostly the patients, we have found them to be very willing to participate, ask and answer the questions that we’re interested in. I think we should always remember that we’re here to serve them and that’s a critical part of everything that we do.

Thanks to all of you for your contributions to this wonderful discussion. On behalf of our panel, we thank you for joining us, and we hope you found this Peer Exchange discussion to be useful and informative.

Transcript Edited for Clarity