Adjuvant Keytruda boosts survival in high-risk kidney cancer study

29 Jan 2024
firstwordpharma.com
Clinical ResultASCOPhase 3Drug Approval
Merck & Co’s anti-PD-1 antibody Keytruda (pembrolizumab) demonstrated a significant 38% improvement in overall survival (OS) versus placebo in an adjuvant setting for patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following surgery.
The company unveiled detailed data from the Phase III KEYNOTE-564 study at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, after initially announcing the positive survival findings in November. A day earlier at the conference, Merck company announced that Keytruda fell short on the OS endpoint in the KEYNOTE-123 bladder cancer study.
KEYNOTE-564 included 994 adults with RCC having intermediate-high risk, high risk or M1 no evidence of disease, who were randomised to receive adjuvant Keytruda or placebo after having undergone nephrectomy. The primary endpoint of disease-free survival was met in 2021, which secured Keytruda’s approval as an adjuvant treatment for RCC in the US, EU, Japan and other countries. Secondary endpoints of the study included OS and safety.
OS rides high
At the third pre-specified interim analysis, Merck said that the estimated OS rate at 48 months was 91.2% for Keytruda recipients, exceeding the 86% for placebo recipients, with consistent OS benefits across key subgroups. Marjorie Green, head of late-stage oncology, global clinical development, at Merck Research Laboratories, said KEYNOTE-564 is “the second Keytruda study to demonstrate a significant OS benefit in an earlier stage of cancer,” the first one being  KEYNOTE-671 in resectable non-small-cell lung cancer.
Meanwhiel, Keytruda’s safety profile in KEYNOTE-564 remained consistent with earlier studies, with no new safety signals identified. The frequency of Grade 3/4 treatment-related adverse events was 18.6% and 1.2% in the Keytruda and placebo arms, respectively.
Keytruda is currently approved in combination with Pfizer's Inlyta (axitinib) for the front-line treatment of advanced RCC, with Merck’s clinical development programme in in this tumour type investigating the anti-PD-1 antibody alone or in combination with Welireg (belzutifan), Lenvima (lenvatinib), and the CTLA-4 monoclonal antibody quavonlimab.
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