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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Renal Cell Carcinoma |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Health Canada Approves KEYTRUDA (pembrolizumab) as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC)
Published date:
10/12/2022
Excerpt:
Merck & Co. (NYSE:MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Source:
Title:
Merck’s KEYTRUDA® (pembrolizumab) Receives Four New Approvals in Japan, Including in High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)
Published date:
09/27/2022
Excerpt:
Merck...announced that KEYTRUDA, Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW)...KEYTRUDA as monotherapy for the adjuvant treatment of certain patients with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, based on data from the KEYNOTE-564 trial.
Source:
Title:
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery
Published date:
01/27/2022
Excerpt:
Merck (NYSE: MRK)…today announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Source:
Published date:
11/18/2021
Excerpt:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated...Renal Cell Carcinoma (RCC)...for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Source:
Published date:
09/28/2021
Excerpt:
Medical treatment for advanced/metastatic papillary RCC...Alternative options include sunitinib [II, B], pembrolizumab [III, B] without additional molecular testing and savolitinib (where available) in MET-driven tumours [III, C].
Source:
Title:
KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Versus Placebo as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Nephrectomy
Published date:
11/01/2023
Excerpt:
Merck...announced that the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its key secondary endpoint of overall survival (OS), for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in OS compared to placebo.
Trial ID:
Source:
Title:
Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
Published date:
09/01/2022
Excerpt:
Disease-free survival was better with pembrolizumab compared with placebo (HR 0·63 [95% CI 0·50–0·80])….Updated results from KEYNOTE-564 support the use of adjuvant pembrolizumab monotherapy as a standard of care for participants with renal cell carcinoma with an increased risk of recurrence after nephrectomy.
DOI:
https://doi.org/10.1016/S1470-2045(22)00487-9
Trial ID:
Source:
Title:
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma Following Surgery
Published date:
12/17/2021
Excerpt:
Merck...today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions....The positive opinion is based on results from the pivotal Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival
Source:
Title:
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) as Adjuvant Therapy in Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery
Published date:
08/10/2021
Excerpt:
Merck...announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC)...This sBLA is based on data from the pivotal Phase 3 KEYNOTE-564 trial...
Source:
Title:
Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for patients with renal cell carcinoma: Randomized, double-blind, phase III KEYNOTE-564 study.
Published date:
06/16/2021
Excerpt:
Pembro demonstrated a statistically significant and clinically meaningful improvement in DFS vs placebo in pts with intermediate-high, high risk or M1 NED RCC.
DOI:
10.1200/JCO.2021.39.15_suppl.LBA5
Trial ID:
Source:
Title:
Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC) Following Surgery
Published date:
04/08/2021
Excerpt:
...Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its primary endpoint of disease-free survival (DFS) for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following nephrectomy...
Trial ID:
