What’s New in Kidney Cancer Research

Welcome to our new blog series where we distill the latest in kidney cancer clinical trials into essential updates for patients, caregivers, and those tracking advancements in this field. With 87 new interventional studies since January 2023, the research landscape is vibrant and full of potential. Here, we translate complex research into practical insights, offering a beacon of hope and knowledge for the kidney cancer community. Join us as we delve into the trials and breakthroughs that are defining the future of kidney care.

Recent Breakthroughs in Kidney Cancer Trials

Before we dive into the updates, I want to emphasize that some of these clinical trials were started five, eight, or even ten years ago. Today’s advancements are only possible because of the sacrifices of patients that enrolled, their families, passionate clinicians, and everyone involved in the drug development industry.

The first trial I want to highlight is the KEYNOTE-564 trial. As reported at the ASCO GU meeting in San Francisco this January, this report marked the most significant impact in years for RCC adjuvant therapy, meaning a treatment given after a primary treatment like surgery to lower the risk the cancer will return. Pembrolizumab, an immunotherapeutic agent already approved in November 2021 for the adjuvant treatment of patients with RCC, for the first time showed a measurable survival benefit in RCC adjuvant therapy since 1973. This trial marked a milestone, being exhibiting a 38% reduction in the risk of death at a median time of 57.2 months since initiation of treatment. Before this trial there were 17 other similar trials that enrolled more than 12,000 patients and all failed to show a benefit. This speaks volumes on what it takes to advance science and how important this study result is!

The CheckMate-9ER trial, with findings shared in January at ASCO GU, continued to highlight the efficacy of the combo nivolumab plus cabozantinib over sunitinib in untreated advanced RCC. As reported by Dr. Maria Teresa Bourlon, MD, MSc, of the Urologic Oncology Clinic, in Mexico City, the trial, which started in 2017, continues to monitor the cohorts of patients enrolled and continues to show significant improvements in progression-free survival, overall survival, and response rates. This is good news for both patients that already are on this regime and newly diagnosed patients that will be treated with this combo. It means that the treatment is performing better than anticipated extending its benefits beyond the initially thought timelines. This cohort of patients will be continued to be monitored and eventually more analyses will be performed to see if the benefits will extend even longer.

Highlighted in a presentation by Dr. Thomas Powels, MD, of the Barts Cancer Institute and member of the KCA Medical Steering Committee, during ASCO GU, the LITESPARK-005 trial revealed that belzutifan, a drug hitting the HIF-2 alpha receptor and recently approved by the FDA for patients with advanced RCC on December 2023, significantly benefits patient-reported outcomes related to symptoms and health-related quality of life for advanced clear cell RCC patients compared to another drug called everolimus. After the approval last year, this result emphasizes the importance of considering the patient’s quality of life in treatment decisions, making belzutifan a notable option in the treatment landscape.

Important insights were reported at ASCO GU from the CheckMate-214 trial, the oldest trial in this report, celebrating 10 years since opening and over 1,000 patients enrolled. The updates reported by Dr. Nizar Tannir, MD, FACP, of The University of Texas MD Anderson Cancer Center, reinforced the long-term survival and durable response advantages of nivolumab/ipilimumab, a dual immunotherapy combination, over a drug called sunitinib. This study allowed the FDA to approve the combination on April 2018 for untreated advanced (stage 4) clear cell RCC. This result marks a median follow-up of over 99 months (8 years and 3 months). What is important here is that patients continue to benefit from this treatment, and this analysis supports the dual immunotherapy regime as a first-line standard of care for advanced RCC, particularly in the most at risk of disease progression populations (intermediate- and poor-risk, as defined by the IMDC).

Reported in a recent publication in Cancer Discovery by Dr. Tony Choueiri at Dana-Faber Cancer Institute and colleagues. Results from the phase III JAVELIN Renal 101 trial brings hope with its innovative combination therapy of avelumab + axitinib (A+Ax) versus the standard sunitinib for advanced renal cell carcinoma (RCC) patients. The trial, which started in 2016 and that is still active but not recruiting new patients, demonstrated prolonged progression-free survival (PFS) with A+Ax regime, highlighting how treatments tailored to immunomodulatory mechanisms can enhance patient outcomes. At the same time, a deep analysis was conducted on how each patient, their tumor characteristics, and the treatment given influences the overall mechanism of action and the response to treatment, showing a quite complex scenario and indicating a way forward to take those parameters into consideration to maximize a response.

In The Lancet Oncology, Dr. Siva Shankar, PhD, MBBS, of the Peter MacCallum Cancer Centre in Parkville, Victoria, Australia and team shared the results from the FASTRACK II trial, which explored stereotactic ablative body radiotherapy (SABR) as a non-invasive treatment for primary RCC. Conducted across several centers in Australia and the Netherlands, this trial emphasized that SABR for the kidney is a highly effective, non-invasive and well-tolerated option to treat localized kidney cancer. This type of radiation therapy is not new in kidney cancer treatment but could be a valid alternative to surgery as a potential definitive therapy, and especially for those who are ineligible for surgery. Depending on each individual situation, it’s important to know that there are alternatives to surgery for early-stage kidney cancer, so please talk to your urologist and evaluate what is the best option for your specific case.

Exciting New Trials on the Horizon

Let’s now explore a couple of trials that have captured our attention for their novel methodologies and the potential they hold for advancing kidney cancer science.

The AB-2100 CAR-T Cell Therapy Trial

One of the trials that has drawn our interest is the upcoming study on AB-2100, a CAR-T cell therapy aimed at treating clear cell renal cell carcinoma (ccRCC). CAR-T therapy represents a breakthrough in cancer treatment, involving the genetic modification of a patient’s T cells to better recognize and attack cancer cells. This trial stands out for its targeted approach against two specific markers: PSMA (Prostate-Specific Membrane Antigen) and CA9 (Carbonic Anhydrase IX). Despite PSMA’s association with prostate cancer, it’s also found in the vasculature of kidney tumors, while CA9 is frequently found in clear cell RCC tumors, making them strategic targets for this therapy.

This focused strategy embodies the innovative spirit of modern oncology, promising a more precise assault on cancer cells with potentially fewer side effects. However, it’s crucial to approach this excitement with cautious optimism. The unique challenges of solid tumors and the complexity of the immune response mean that the path to success is uncertain, and positive results, while hoped for, are not assured. The trial estimates to complete in May 2027.

The CCBW Program: A Study on In-Home vs. In-Clinic Nivolumab Administration

Another trial we find noteworthy is the Cancer CARE Beyond Walls (CCBW) program, which is investigating the effects of administering nivolumab, a checkpoint inhibitor therapy for RCC, in patients’ homes compared to traditional in-clinic settings. The trial is not for kidney cancer patients only but includes many types of cancer. We have selected this trial because it has a patient-centered approach. It recognizes the importance of not just the efficacy of treatments but also the quality of life and convenience for patients undergoing therapy. By potentially shifting treatment administration to the comfort of a patient’s home, this study explores whether we can maintain treatment effectiveness while also enhancing the overall treatment experience.

How to Stay Informed and Get Involved

Staying informed and potentially getting involved in clinical trials can be a pivotal part of navigating your kidney cancer journey. For those eager to delve deeper into the trials mentioned or explore other opportunities, the Kidney Cancer Association website offers a comprehensive Clinical Trial Finder. This tool is designed to help patients and caregivers easily search for trials tailored to their specific situation, offering a gateway to the latest treatments and research advancements. We encourage you to use this resource to keep abreast of emerging studies and consider discussing participation with your healthcare provider, as your involvement could contribute to groundbreaking discoveries in kidney cancer treatment. Patients and caregivers play a pivotal role in the success of clinical trials. By participating, you contribute to the advancement of medical knowledge and help future patients receive better care. If you’re considering joining a trial, we encourage discussing it with your healthcare provider to understand how it might fit into your treatment plan.

We hope this update has enriched your understanding of kidney cancer treatments. Your insights are invaluable to us, so please share your thoughts on this edition. The Kidney Cancer Association is here to empower you with information, helping patients, caregivers, and families navigate the complex terrain of clinical trials. Feedback on the clarity and usefulness of the content is always welcome as we strive to ensure our resources are both informative and accessible.

As we anticipate our next update, we are dedicated to uncovering the latest research, offering new perspectives, and honoring the collective strength and determination of our community. With the Kidney Cancer Association, you’re an active part of a shared journey toward innovation in care. #UnstoppableTogether, let’s continue to advance, armed with knowledge and united in hope for the future.