Merck's Keytruda Delivers Reduced Risk of Death in Adjuvant NSCLC
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The KEYNOTE-091 study, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, found that patients who received adjuvant treatment with Keytruda (pembrolizumab) saw a 24% reduced risk of disease recurrence or death compared to those who were given a placebo. Disease-free survival (DFS) is one of the study's primary endpoints, alongside improvement in DFS for patients whose tumors express PD-L1.
In the Phase III study, the researchers also saw that the median DFS for those who took Keytruda was 53.6 months, or about a year better compared to just 42 months in the placebo group. Details of these findings are presented at the European Society for Medical Oncology (ESMO) Virtual Plenary.
The result marks a major event as it is the first positive outcome reported for the injectable drug in the adjuvant setting for NSCLC. It is also the sixth study delivering positive results involving the use of Keytruda in early cancer stages.
"Keytruda has become foundational in the treatment of metastatic non-small cell lung cancer, and we are pleased to present these data showing the potential of Keytruda to help more patients with lung cancer in earlier stages of disease. We thank the patients, their caregivers and investigators for participating in this study," said Dr. Roy Baynes, the senior vice president and head of global clinical development and chief medical officer of Merck Research Laboratories, in a statement.
Keytruda is an anti-programmed death receptor-1 therapy that works by boosting the immune system's ability to detect and fight tumor cells. It is being studied in over 1,700 clinical trials worldwide for various cancer and therapy settings. It is indicated for the first-line treatment of patients with NSCLC expressing PD-L1, based on an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.
The KEYNOTE-091 study observed 1,177 patients, half of which were given 200mg of Keytruda intravenously every three weeks for one year, or a maximum of 18 doses. Its secondary endpoints included overall survival and lung cancer-specific survival.
"Lung cancer is most treatable at earlier stages, and adding treatment after surgery may help reduce the risk of recurrence. We are encouraged by these new Phase III data, as they represent the first time adjuvant immunotherapy has demonstrated a statistically significant and clinically meaningful improvement in disease-free survival for patients with stage IB-IIIA non-small cell lung cancer," noted Professor Mary O'Brien, consultant medical oncologist and head of the Lung Unit at The Royal Marsden NHS Foundation Trust and the study's co-principal investigator.
The study was conducted with resources from Merck, known as MSD outside of Canada and the U.S., the European Thoracic Oncology Platform (ETOP) and the European Organization for Research and Treatment of Cancer (EORTC).