Immunotherapy drug achieves trial-first in fifty years

Results from a Phase III, randomised, placebo-controlled clinical trial have for the first time in fifty years, demonstrated an overall survival benefit from an adjuvant therapy in kidney cancer. Pembrolizumab targets a “checkpoint” pathway that is key in enabling cancer cells to avoid being destroyed by the immune system. As a result, the immunotherapy drug supports the immune system’s T cells fight tumours, the researchers highlighted.

Treatment with pembrolizumab post-surgery was associated with a 38 percent reduction in risk of death compared with placebo in patients with clear-cell renal-cell carcinoma (ccRCC) at high risk for recurrence. This finding is based on analysis from the KEYNOTE-564 clinical trial.

The KEYNOTE-564 study aimed to evaluate adjuvant pembrolizumab following nephrectomy within 12 weeks prior to randomisation, according to the team.

The study enrolled 994 patients internationally, who were randomised to pembrolizumab once every three weeks for approximately a year, or a placebo.

Further results from the pembrolizumab study

In the first interim analysis of the KEYNOTE-564 study, it was reported that adjuvant pembrolizumab improved disease-free survival in those with kidney cancer who were at high risk of relapse.

Based on data from the third interim analysis, completed after a median of 57.2 months of follow up, adjuvant pembrolizumab was found to “significantly” prolong overall survival when compared to placebo.

Importance of the findings

Prior to the approval of pembrolizumab as adjuvant treatment for patients with kidney cancer in 2021, which were based the KEYNOTE-564 results, there was no widely available accepted standard of care for ccRCC after treatment with surgery.

With adjuvant pembrolizumab now standard of care for these patients, the researchers confirmed that they are investigating if this treatment can be improved by combining pembrolizumab with the HIF-2 inhibitor belzutifan.

“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,” stated Dr Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute. “We showed pembrolizumab extends survival. It does not only delay recurrence.”

Findings from the study were presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancer Symposium in January 2024.

The study of the immunotherapy drug was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co.

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