Dr. Eric Jonasch

It is important to expand clinical trial access for patients with kidney cancer in order to ensure a representative study population.

Expanding Clinical Trial Access for Patients With Kidney Cancer

It is important to expand clinical trial access for patients with kidney cancer in order to ensure a representative study population, according to Dr. Eric Jonasch. He added that this makes it more likely that research findings will translate into effective treatments for more patients.

“The more representative our study population is of the broader population, the more likely it is that our research findings will lead to similar positive outcomes in the real world,” Jonasch, a principal investigator at the Kidney Cancer Research Consortium (KCRC), emphasized.

KCRC is the first and only clinical research consortium dedicated to kidney cancer, according to the research consortium's website, noting that the company continue to support collaborative efforts and ongoing clinical research for patients with kidney cancer.

To delve deeper into this topic, Jonasch sat down for an interview with CURE to discuss how expanding clinical trial access may help bring new treatments to more patients as quickly as possible.

Jonasch is a professor in the Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, in Houston. He also serves as director of the von Hippel Lindau Center at MD Anderson Cancer Center and is vice chair of the National Comprehensive Cancer Network Kidney Cancer Guidelines.

What does new research mean for patients with kidney cancer interested in clinical trials, and how could expanding access help bring new treatments to more people faster?

The collective work demonstrated in [ongoing research], particularly with the KCRC, shows that clinical trials are being developed to improve upon already effective treatments. This means that these trials are increasingly likely to both advance our knowledge and directly benefit patients.

The value of this approach is increasing by expanding access to more patients, which allows us to gather a more representative study population. When a drug is eventually approved, having a diverse study population makes it more likely that the drug will be effective for a broader range of patients in the general population. Therefore, the more representative our study population is of the broader population, the more likely it is that our research findings will lead to similar positive outcomes in the real world.

Transcript has been edited for clarity and conciseness.

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von Hippel-Lindau (VHL) disease is a rare inherited mutation that affects approximately 10,000 individuals in the United States. However, these patients have hope on the horizon, according to Dr. Eric Jonasch.

A recent study — presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting – showed that treatment with MK-6482 appeared to be well tolerated and induced clinical responses among patients with VHL–associated renal cell carcinoma (RCC).

The trial showed an objective response rate of 27.9%. Moreover, eight patients who had an unconfirmed response showed an objective response rate of 41.0%. Additionally, 86.9% of patients had a decrease in the size of their target lesions and median time to response was 5.5 months.

Jonasch, professor of genitourinary medical oncology at The University of Texas MD Anderson Cancer Center, discussed the trial results with 

, offering hope on the horizon for these individuals.

So, VHL disease at this time does not have an FDA approved therapy. It’s a hereditary disorder that affects the eyes, brain, spine, pancreas, adrenal glands, and kidneys. These individuals who have this — there are about 10,000, in the United States – basically face a lifetime of surveillance scans and surgical interventions or other types of interventions.

So, having something that can actually shrink these without undergoing surgery would be a huge boost.

The hope here is that this agent be approved and that in individuals who do have lesions that are starting to get to a size where they might need some type of intervention that they could get this drug instead of a surgical intervention and that they could be on this for some period of time. That would either delay or prevent the need for that surgical intervention.

The long-term dream scenario would be that, this is a disease in adolescents and young adults, so the first manifestations can occur in childhood or most commonly in adolescence or young adulthood, we could come up with a prevention strategy where individuals would receive this drug and then prevent the development of organ manifestations and that would require a follow-up study asking a different question. That could really help us to help this patient population more.

From a patient perspective, it’s been an incredible joy seeing how this drug really has helped the lives of individuals living with VHL. Being personally involved in seeing how this has provided them with benefit and as a person who has been working with individuals with VHL disease now for 20 years, it makes me incredibly happy to see that we finally have something that can help these people.

The HIF-2a Inhibitor induced clinical responses among patients with von Hippel-Lindau disease–associated kidney cancer, according to results presented at the 2020 ASCO Virtual Scientific Program.
 

Dr. Eric Jonasch

Expanding Clinical Trial Access for Patients With Kidney Cancer

MK-6482 Shows Promise in von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

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