Although the recent FDA approval of Keytruda was exciting for high-risk, nonmetastatic renal cell carcinoma, an expert from The University of MD Anderson Cancer Center notes more work is needed, particularly when it comes to individualizing treatment.
The recent Food and Drug Administration (FDA) approval of Keytruda (pembrolizumab) brought an exciting new treatment option for patients with high-risk, non-metastatic renal cell carcinoma (RCC), but questions remain when it comes to individualizing care for these patients, explained Dr. Pavlos Msaouel.
Msaouel is a clinician and cancer biologist in the Department of Genitourinary Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston. He recently discussed new treatment options for high-risk, non-metastatic RCC, which is the most common type of kidney cancer, in an interview with CURE®.
“With the exciting results of the KEYNOTE-564 trial, which led to the FDA approval of adjuvant (Keytruda) for high-risk nonmetastatic RCC, the question now becomes: how do we choose whether or not to offer adjuvant therapy to our patients based on patient-level characteristics?” Msaouel said.
Adjuvant therapy comes after the “main” line of treatment, which in this case was the surgical removal of the kidney, known as nephrectomy. In the KEYNOTE-564 study, Keytruda improved disease-free survival (defined as the time from treatment to recurrence, metastasis, or death) and overall survival (time from diagnosis or treatment start when patients are alive).
However, Msaouel said that research is also needed in the real-world setting (so not in a clinical trial), as well as for different cancer subtypes and characteristics.
“We need to improve our recurrence risk estimations by incorporating knowledge from genomics and other types of ‘omics,’ such as radiomics,” he said. “In addition, we need interventional experimental-type research in order to accurately estimate the adjuvant treatment effects for rare kidney cancer histologies, because KEYNOTE-564 only included patients with the most common kidney cancer histology, clear (cell) renal cell carcinoma.”
Given the results of KEYNOTE-564, however, Msaouel said that this immunotherapy drug should be explored as both a single-agent drug and in combination with other drugs. And more research is needed to determine whether certain patients should receive adjuvant therapy at all.
“We need to generate the kind of data that will allow us to make patient-specific decisions. How can we say — based on each specific patient — whether an adjuvant therapy is preferable or not? Because in some patients, the side effects or other costs, including the financial and other logistical costs of adjuvant therapy, may not be worth the benefit they’re getting,” Msaouel said. “Figuring out how to balance that trade-off between risks and benefits of each individual patient is something that we need to work on more.”
While more research is certainly needed, Msaouel said that the approval of Keytruda for high-risk nonmetastatic RCC is a practice-changing one. As researchers and clinicians learn more about who is best fit to receive the drug and whether or not it should be given in combination, outcomes will continue to improve for this patient population.
“I would say that the main takeaway for patients is that for the first time, we have immunotherapy as a type of therapy. An exciting new class of agents (are) being introduced earlier on in the disease course in patients who do not yet have visibly metastatic disease, meaning that the cancer hasn’t spread to other organs, and may potentially increase the fraction of patients who may be cured so that the cancer does not come back,” Msaouel said.
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