Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Significant Improvement in Disease-Free Survival as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer Regardless of PD-L1 Expression
Jan 12, 2022 01:00
CST Updated
01:00
MSD
Pharmaceutical R&D and Manufacturer
News on January 11, 2022 /BioValleyBIOON/ -- MSD (Merck & Co) recently announced that the Phase 3 KEYNOTE-091 trial (also known as: EORTC-1416-LCG/ETOP-8-15-PEARLS) evaluating the anti-PD-1 therapy Keytruda® (pembrolizumab) as adjuvant treatment for Stage IB-IIIA non-small cell lung cancer (NSCLC) has met one of the dual primary endpoints, disease-free survival (DFS).
It is worth mentioning that,This is the first study to yield positive results for Keytruda adjuvant treatment in IB-IIIA stage NSCLC.Keytruda has become a foundational therapy for treating metastatic NSCLC. Results from the KEYNOTE-091 trial support Keytruda's potential role in IB-IIIA stage NSCLC.
The KEYNOTE-091 trial is being conducted in patients with stage IB-IIIA NSCLC, regardless of PD-L1 expression status, to evaluate Keytruda as an adjuvant treatment following surgical resection. Based on the interim analysis review conducted by the Independent Data Monitoring Committee (IDMC):In patients with stage IB-IIIA NSCLC, Keytruda adjuvant therapy demonstrated a statistically significant and clinically meaningful improvement in DFS compared to placebo.
At the interim analysis, Keytruda treatment improved DFS in patients with tumor PD-L1 expression (Tumor Proportion Score [TPS] ≥50%) compared to placebo; however, according to the pre-specified statistical analysis plan, this dual primary endpoint did not achieve statistical significance. The trial will continue with further analysis.TumorPatients with high levels of PD-L1 expression (TPS≥50%) were assessed for overall survival (OS), a key secondary endpoint of the trial.
In the trial, the safety of Keytruda was consistent with what was observed in previously reported studies. Detailed results will be presented at an upcoming medical conference.MeetingPublished and submitted to the regulatory authorities.
Globally, lung cancer is the leading cause of cancer-related deaths, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of all lung cancer cases. Early detection and treatment of lung cancer remain crucial. Surgical intervention is widely regarded as the first and most important treatment for the majority of patients with early-stage NSCLC; however, it is estimated that 43% of patients who undergo surgery will experience disease recurrence.
The goal of adjuvant therapy is to reduce the risk of cancer recurrence after surgery. Data from the KEYNOTE-091 trial indicate that adjuvant treatment with Keytruda can reduce the risk of disease recurrence or death post-surgery in patients with stage IB-IIIA NSCLC.
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.
As of now, globally, there are more than 10 PD-(L)1TumorImmune therapy has been approved for marketing, with Keytruda leading the field. It has received approval for multiple treatment indications, and its global sales reached $14.38 billion in 2020, representing a 30% increase from the previous year.
MSD has the largest immuno-oncology clinical development program in the industry and is investigating Keytruda across multiple typesTumorRole in Treatment and Background: Early detection of cancer may offer patients a greater chance of long-term survival, as many cancers are considered most treatable and curable during the early stages of the disease. Based on a profound understanding of Keytruda's role in advanced cancer, MSD is investigating the use of Keytruda for early-stage cancer treatment. Currently, there are approximately 20 ongoing registrational studies evaluating Keytruda for the early treatment of various types of cancer. (Bioon.com)