European Commission Approves Merck’s KEYTRUDA as First Adjuvant Immunotherapy for Early-Stage Renal Cell Carcinoma with High Risk of Recurrence
Jan 31, 2022 21:12
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21:12
MSD
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European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Kidneys (Image source: mymed.com)
News on January 31, 2022 /BioValleyBIOON/ -- MSD (Merck & Co) recently announced that the European Commission (EC) has approved the anti-PD-1 therapy Keytruda (trade name: Keytruda®, generic name: pembrolizumab): as a monotherapy for adjuvant treatment of adult patients with renal cell carcinoma (RCC) who are at increased risk of recurrence following nephrectomy (surgical removal of the kidney) or nephrectomy and resection of metastatic lesions.
In November 2021, Keytruda was approved by the United StatesFDAApproved for adjuvant treatment of RCC patients with intermediate-high or high risk of recurrence after nephrectomy (surgical removal of the kidney) or nephrectomy and metastatic lesion resection.
It is worth mentioning that,Keytruda is the first immunotherapy approved in the U.S. and Europe for adjuvant treatment of the aforementioned RCC patients.This approval is based on data from the pivotal Phase 3 KEYNOTE-564 study, the first Phase 3 study to show positive results with adjuvant immunotherapy in RCC, confirming the value of Keytruda in the early treatment of RCC.
The KEYNOTE-564 study was conducted in RCC patients with intermediate-high or high risk of recurrence after nephrectomy or nephrectomy and metastasectomy. The data showed that, compared to the placebo group, the Keytruda treatment group demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS). The specific data are as follows:Compared with the placebo group, the risk of disease recurrence or death was significantly reduced by 37% in the Keytruda treatment group (HR=0.63; 95% CI: 0.50-0.80; p<0.0001). The median DFS was not reached in either group.
Keytruda is the first immunotherapy to demonstrate clinical benefit in the adjuvant treatment of RCC. With nearly half of patients with early-stage RCC experiencing disease recurrence after surgery, the robust efficacy data from the KEYNOTE-564 study indicate that Keytruda will become the new standard of care for patients with early-stage RCC.
Dr. Scot Ebbinghaus, Vice President of Clinical Research at Merck Sharp & Dohme AG Research Laboratories, stated: "Keytruda is the first adjuvant therapy approved in Europe for certain patients with renal cell carcinoma, offering an early immunotherapy option in the treatment process. This approval reflects our progress in applying Keytruda to cancer patients at earlier stages, with the goal of helping patients worldwide prevent disease recurrence."
KEYNOTE-564 is a randomized, double-blind, Phase 3Clinical Trial(NCT03142334), is evaluating Keytruda as a monotherapy for adjuvant treatment in patients with renal cell carcinoma (RCC) who are at intermediate-high or high risk, or have M1 no evidence of disease (M1 NED) following nephrectomy or nephrectomy and metastasectomy. The study enrolled a total of 950 patients, who were randomly assigned to two groups receiving either Keytruda (200mg intravenous infusion on day 1 of each 3-week cycle for up to 17 cycles) or placebo (normal saline intravenous infusion on day 1 of each 3-week cycle for up to 17 cycles). The primary endpoint is disease-free survival (DFS), with secondary endpoints including overall survival (OS) and safety.
Previously released interim analysis data showed that the study met its primary endpoint: after a median follow-up of 23.9 months, compared with the placebo group, the Keytruda treatment group demonstrated a statistically significant improvement in DFS, with a 32% reduction in the risk of disease recurrence or death (HR=0.68; 95% CI: 0.53-0.87; p=0.0010). Updated efficacy results after a median follow-up of 29.7 months showed that Keytruda significantly reduced the risk of disease recurrence or death by 37% (HR=0.63; 95% CI: 0.50-0.80; p<0.0001). Overall, the DFS benefits were consistent across different subgroups. Based on cumulative events, the median DFS was not reached in either treatment group. The trial will continue to evaluate OS, a key secondary endpoint of the study. No new immune-related adverse events were observed in the adjuvant therapy setting.Adverse Reactions。
Renal Cell Carcinoma (RCC) is by far the most common type of kidney cancer, accounting for approximately 90% of all kidney cancer cases. The incidence of RCC in men is about twice that in women. Most RCCs are incidentally discovered during imaging examinations for other abdominal conditions. Worldwide, it is estimated that in 2020, newDiagnosisThere are approximately 431,300 cases of kidney cancer, with nearly 179,400 deaths attributed to the disease.
Keytruda belongs to the PD-(L)1 tumor immunotherapy, which is currently one of the most highly regarded types of cancer immunotherapies. It aims to utilize the body's own immune system to fight cancer by blocking the PD-1/PD-L1 signaling pathway to induce cancer cell death, showing potential for treating various types.TumorThe potential.
In terms of RCC, Keytruda has previously been approved in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced RCC. Currently, MSD is continuing to study Keytruda as a monotherapy and in combination with other cancer treatments across multiple treatment settings (including adjuvant therapy) and disease stages (advanced or metastatic disease) through its extensive clinical program. (Bioon.com)