Merck’s KEYTRUDA Receives Positive CHMP Opinion for Adjuvant Treatment of Early-Stage Renal Cell Carcinoma in the EU
Dec 21, 2021 01:46
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01:46
MSD
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Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
Renal Cancer (Image Source: vecteezy.com)
News on December 20, 2021 /BioValleyBIOON/ -- MSD (Merck & Co) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of the anti-PD-1 therapy Keytruda (generic name: pembrolizumab): as a monotherapy forAdjuvant treatment for adult patients with renal cell carcinoma (RCC) at increased risk of recurrence after nephrectomy (surgical removal of the kidney) or nephrectomy and metastatic lesion resection.Now, the CHMP opinion will be submitted to the European Commission (EC) for review, which typically makes a final decision within 2 months.
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 for adjuvant treatment of the aforementioned RCC patients.. This indication was granted through the priority review process.FDAApproved. This approval is based on data from the pivotal Phase 3 KEYNOTE-564 study, the first Phase 3 study to show positive results for 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 with the placebo group,Keytruda Treatment Group Shows Statistically Significant and Clinically Meaningful Improvement in Disease-Free Survival (DFS). The specific data shows that, compared with the placebo group, patients in the Keytruda treatment groupThe risk of disease recurrence or death was significantly reduced by 32%.(HR=0.68 [95% CI, 0.53-0.87]; p=0.0010). The median DFS was not reached in either group.
Keytruda is the first immunotherapy to demonstrate clinical benefit in the adjuvant treatment of RCC.Since nearly half of the early-stage RCC patients experience disease recurrence after surgery, the robust efficacy data from the KEYNOTE-564 study indicates,Keytruda Will Become the New Standard of Care for Early-Stage RCC Patients.
Dr. Scot Ebbinghaus, Vice President of Clinical Research at Merck & Co., Inc. Research Laboratories, stated: "In Europe, there are currently no approved treatments in the adjuvant setting for patients with early-stage renal cell carcinoma who have an increased risk of recurrence after nephrectomy to help reduce the risk of cancer recurrence. The CHMP's positive opinion on Keytruda is an important step toward providing these patients with adjuvant immunotherapy and demonstrates MSD's progress in offering new options for treating early-stage cancer."
KEYNOTE-564 Study Results (Click the image to view a larger version)
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 risk, high risk, or M1 no evidence of disease (M1 NED) following nephrectomy or nephrectomy and metastasectomy. The study enrolled 950 patients, who were randomly assigned to 2 groups: receiving 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.
The results published this June showed that the study met its primary endpoint: with a median follow-up of 24.1 months (14.9-41.5), compared with the placebo group,Keytruda Treatment Group Shows Statistically Significant Improvement in DFS, with a 32% Significant Reduction in Risk of Disease Progression or Recurrence(HR=0.68; 95% CI: 0.53-0.87; p=0.0010). The estimated 2-year DFS rate was 77.3% in the Keytruda treatment group and 68.1% in the placebo group. Overall,The benefits of DFS are consistent across different subgroups.. Based on the cumulative events, neither of the two treatment groups reached the median DFS.
In addition, compared with the placebo group,Keytruda Treatment Group Shows Favorable OS Trend, Reduces Mortality Risk by 46%(HR=0.54; 95%CI:0.30-0.96; p=0.0164). The trial will continue to evaluate OS, a key secondary endpoint of the study.
In terms of safety, 3-5 grade treatment-related adverse events (TRAEs) occurred in 18.9% of patients in the Keytruda group and 1.2% in the placebo group, while TRAEs leading to any treatment discontinuation were observed in 17.6% and 0.6% of patients, respectively. The most common TRAEs of any grade (occurring in ≥5% of patients) in the Keytruda group were fatigue (20.3%), pruritus (18.6%), and hypothyroidism (17.6%), whereas in the placebo group, they were fatigue (14.3%), pruritus (11.5%), and diarrhea (10.3%). The most common immune-mediated adverse events of any grade (occurring in ≥3% of patients) in the Keytruda group included hypothyroidism (21.1%) andHyperthyroidism(11.9%), and hypothyroidism in the placebo group (3.6%). No treatment-related deaths occurred.
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 a highly regarded class of cancer immunotherapy. 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, offering potential treatment for various types.TumorThe potential.
In terms of RCC, Keytruda was previously 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)