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Sponsored Insight


IMMUNOTHERAPY POST-SURGERY IMPROVES OVERALL SURVIVAL FOR KIDNEY CANCER

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For the first time in fifty years, results from a phase 3 randomized,
placebo-controlled trial have shown an overall survival benefit from an adjuvant
therapy in patients with kidney cancer.

Treatment with pembrolizumab, an immunotherapy drug, after surgery significantly
prolonged overall survival in patients with clear-cell renal-cell carcinoma
(ccRCC) at high risk for recurrence, according to an analysis of results from
the KEYNOTE-564 study. Pembrolizumab was associated with a 38% reduction in risk
of death compared with placebo.

“We can now tell our patients that pembrolizumab after surgery not only delays
recurrences but also helps them live longer,” said the study’s lead
investigator Toni Choueiri, MD, of Dana-Farber Cancer Institute.

Choueiri, director of the Lank Center for Genitourinary Oncology at Dana-Farber,
is the first author of the study published on April 17, 2024 in the New England
Journal of Medicine. Choueiri previously presented the findings at the American
Society of Clinical Oncology (ASCO) Genitourinary Cancer Symposium on January
27, 2024.

The KEYNOTE-564 trial was designed to evaluate adjuvant pembrolizumab following
nephrectomy (removal of the cancerous kidney) within 12 weeks prior to
randomization. The double-blind, phase 3 study, carried out at hundreds of sites
internationally, enrolled 994 patients who were randomized to pembrolizumab once
every three weeks for about a year, or a placebo. Pembrolizumab targets a
molecular pathway that cancer cells commandeer to evade attack by the body’s
immune system. By blocking this “checkpoint” pathway, the drug helps free the
immune system’s army of T cells to combat tumors.

For inclusion in the trial, patients had to have a clear-cell component to their
tumor and be at intermediate or high risk of recurrence. Some patients with
resected metastases after nephrectomy were also eligible. For patients with
ccRCC, surgery is intended to be curative. However, between 30 and 50% of
patients can experience recurrence after surgery. Recurrences often result in
metastatic disease, which is usually incurable.

Investigators have been trying to find ways to reduce recurrences and prolong
survival for this patient group since 1973, the date of the first randomized
controlled trial of an adjuvant therapy. An adjuvant therapy is a medicine
intended to enhance efficacy after primary treatment of the cancer, which in
this case is surgery.

“Since 1973, more than 12,000 patients with kidney cancer participated in
adjuvant studies versus a control arm and none of the studies showed the
experimental arm extends lives until now with the KEYNOTE-564 study,” says
Choueiri. “We showed pembrolizumab extends survival. It doesn’t only delay
recurrence.”

In the first interim analysis of the KEYNOTE-564 study, Choueiri and colleagues
reported that adjuvant pembrolizumab improved disease-free survival in patients
with kidney cancer at high risk of relapse. Pembrolizumab was approved in 2021
as adjuvant treatment for patients with kidney cancer based on these KEYNOTE-564
results.

This third interim analysis was completed after a median of 57.2 months of
follow up. Adjuvant pembrolizumab significantly prolonged overall survival
versus placebo in trial participants. Overall survival benefits with
pembrolizumab were consistent across subgroups, irrespective of stage, risk
stratification, immunological biomarkers, and other characteristics.

Approximately 18% of patients stopped therapy due to side effects associated
with pembrolizumab. No treatment related deaths were reported with
pembrolizumab. The investigators reported previously that adjuvant pembrolizumab
did not result in clinically meaningful deterioration of health-related quality
of life.

Prior to the approval of pembrolizumab, there was no widespread accepted
standard of care for patients with ccRCC after treatment with surgery. Now, with
adjuvant pembrolizumab as standard of care for this patient group, Choueiri and
colleagues are investigating whether it can be improved by combining
pembrolizumab with the HIF-2 inhibitor belzutifan.

At the 2024 ASCO Annual Meeting, Dr. Choueiri is sharing the findings from
another research study. He will present findings from the phase 3 CLEAR trial
(Abstract #4504, Biomarker analyses in patients with advanced renal cell
carcinoma). Information about Dana-Farber at ASCO can be found here.



What we do here changes lives everywhere. Learn more about Dana-Farber’s
momentum of discovery.

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