Patients With Kidney Cancer ‘Continue to See Benefit’ With Post-Surgical Keytruda

Long-term follow-up of the KEYNOTE-564 clinical trial showed that post-surgical Keytruda (pembrolizumab) continued to improve outcomes for patients with intermediate or high-risk, clear cell renal cell carcinoma (RCC) over placebo.

Data from this trial led to the November Food and Drug Administration (FDA) approval of Keytruda administered after nephrectomy (surgical removal of one of both kidneys) or nephrectomy and resection of metastatic lesions. Even more recently, researchers presented 30-plus-month follow-up findings from the study at 2022 ASCO Genitourinary Cancers Symposium.

“The median follow-up went from 24 to 30 months, and we continue to see benefit,” said Dr. Toni K. Choueiri, lead study author and director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute in Boston, during an interview with CURE®. “And when we looked in key subgroups, the benefit was also in favor of (Keytruda over placebo).”

These findings are particularly exciting, as before the FDA approval for adjuvant (post-surgical) Keytruda, there were no treatment options for this patient population to reduce their risk of cancer recurrence. Now, patients may feel even more confident with the drug, as longer follow-up shows that Keytruda continues to fight cancer and improve outcomes.

KEYNOTE-564 included 994 patients who underwent nephrectomy within the last 12 weeks and randomized them to receive either 200 mg of Keytruda every three weeks for 17 cycles — which is about a year — or to receive a placebo treatment.

At an average follow-up of 30.1 months, disease-free survival with Keytruda was maintained and was consistent across subgroups of patients who had no metastases, local and distant metastases. Estimated disease-free survival at 24 months was 78.3% and 67.3% in the Keytruda and placebo groups, respectively.

“It continues to show the activity of (Keytruda),” Choueiri said.

Regarding side effects, there were no major changes seen with the longer study follow-up, Choueiri explained, with no additional severe (grade 3-4) side effects or use of steroids for immune-related side effects. There was no decrease in quality of life, either.

“One thing that we also looked at was toxicities and additional treatment-related (side effects) with additional follow-up and there was really the same toxicity profile and no major changes,” Choueiri said.

Since many patients on the study who were prescribed Keytruda treatment were still alive at the latest follow-up, the average overall survival was not met. Choueiri also mentioned that patients enrolled on the trial should continue to be monitored as time goes on to better understand the long-term benefits of post-surgical Keytruda for patients with high-risk RCC.

“The most important thing to accumulate and have more follow-up with more events is to clearly (see) overall survival. Now I think that’s going to be major,” Choueiri said. “We’re going to look at additional endpoints in the future like (disease-free survival), so the data will still give (us) more information as we go.”

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