FDA Approves Single-Agent Pembrolizumab as Adjuvant Therapy for Renal Cell Carcinoma

Clear cell renal carcinoma.

The FDA has approved pembrolizumab (Keytruda®, Merck) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy with resection of metastatic lesions.

“Patients with renal cell carcinoma who undergo nephrectomy [had] no options for adjuvant therapy to reduce the risk of recurrence that have high levels of supporting evidence [prior to this approval],” wrote Toni K. Choueiri, MD, Director of the Kidney Cancer Center and the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute, and colleagues, in their publication of the KEYNOTE-564 trial (NCT03142334), on which the approval was based.

The double-blind, phase 3 trial enrolled 994 patients with clear cell renal cell carcinoma who were at high risk of recurrence after nephrectomy, with or without metastasectomy. These patients were randomized 1:1 to receive either 200 mg adjuvant pembrolizumab or placebo intravenously once every three weeks for a maximum of 17 cycles. The primary end point was disease-free survival. Secondary end points were overall survival and safety.

Pembrolizumab demonstrated a statistically significant improvement in disease-free survival compared with placebo; 77.3% of patients achieved disease-free survival at 24 months versus 68.1% of patients in the placebo arm. For patients in the pembrolizumab treatment arm, the risk of disease recurrence or death was reduced by 32%, a statistically significant improvement compared with placebo (P=0.0010). Median disease-free survival was not reached in either group.

In at least 20% of patients receiving pembrolizumab as a single agent, adverse reactions included fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritus, dyspnea, constipation, pain, abdominal pain, nausea, and hypothyroidism.

“Pembrolizumab treatment led to a significant improvement in disease-free survival as compared with placebo after surgery among patients with kidney cancer who were at high risk of recurrence,” concluded Dr. Choueiri and colleagues in their August 2021 publication of the KEYNOTE-564 results in The New England Journal of Medicine.

The recommended dose of single-agent pembrolizumab in the adjuvant setting for patients with renal cell carcinoma is 200 mg every three weeks or 400 mg every six weeks.

For More Information

Choueiri TK, Tomczak P, Park SH, et al (2021). Adjuvant pembrolizumab after nephrectomy in renal-cell carcinoma. N Engl J Med, 385(8):683-694. DOI:10.1056/NEJMoa2106391

Clinicaltrials.gov (2021). Safety and efficacy study of pembrolizumab (MK-3475) as monotherapy in the adjuvant treatment of renal cell carcinoma post nephrectomy (MK-3475-564/KEYNOTE-564). NLM identifier: NCT03142334.

Keytruda® (pembrolizumab) prescribing information (2021). Merck. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s113lbl.pdf

Merck (2021). FDA approves Merck’s KEYTRUDA® (pembrolizumab) as adjuvant therapy for certain patients with renal cell carcinoma (RCC) following surgery. Available at: https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-as-adjuvant-therapy-for-certain-patients-with-renal-cell-carcinoma-rcc-following-surgery/

Image credit: Mikael Häggström. Licensed under CC0 1.0

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