Merck’s KEYTRUDA® (Pembrolizumab) Plus Chemotherapy Approved as First-Line Treatment for Advanced Esophageal Cancer in Japan and China
Dec 15, 2021 01:51
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01:51
MSD
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Esophageal Cancer (Image Source: medindia.net)
December 14, 2021 /BioValleyBIOON/ -- MSD (Merck & Co) recently announced that the Japanese Pharmaceuticals andMedical DeviceThe Pharmaceuticals and Medical Devices Agency (PMDA) has approved the anti-PD-1 therapy Keytruda (generic name: pembrolizumab), in combination with chemotherapy (5-fluorouracil [5-FU] + cisplatin),First-line treatment for advanced or recurrent esophageal cancer that cannot be radically resectedPatient.
Keytruda + Chemotherapy Represents the First Anti-PD-1/PD-L1-Based Regimen Approved in Japan for First-Line Treatment of Advanced Esophageal Cancer, Marking the Second Indication for Keytruda in Japan for Esophageal Cancer Treatment and the 16th Approved Indication for Keytruda. In 2020, Keytruda was approved in Japan for second-line treatment.TumorPatients with unresectable, advanced, or recurrent esophageal squamous cell carcinoma (ESCC) expressing PD-L1. In Japan, patients with advanced esophageal cancer face a poor prognosis under current chemotherapy regimens, and Keytruda + chemotherapy will provide a new treatment option.
In China, Keytruda was approved in September 2021, in combination with chemotherapy (platinum + fluoropyrimidine), for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal cancer or gastroesophageal junction (GEJ) adenocarcinoma.Previously, Keytruda was approved as a monotherapy for second-line treatment.TumorPatients with recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) expressing PD-L1 (CPS≥10). Notably, Keytruda + chemotherapy is the first anti-PD-1 regimen approved in China as a first-line treatment for advanced esophageal cancer or GEJ cancer, regardless of histology or PD-L1 expression.This approval will change the current first-line treatment model for these patients.。
KEYNOTE-590 Trial Overall Study Population Results
This approval was based on the results of the pivotal Phase 3 KEYNOTE-590 trial (NCT03189719). The data showed that, in chemotherapy-naive (i.e., not having received prior chemotherapy) patients with unresectable advanced or recurrent esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma, or adenocarcinoma of the gastroesophageal junction (Siewert Type 1),Compared with standard-of-care chemotherapy (5-Fu + Cisplatin), the Keytruda + chemotherapy regimen demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS).，Regardless of histology or PD-L1 expression statusSpecifically, compared with chemotherapy, Keytruda + chemotherapy reduced the risk of death by 27% (HR=0.73[95%CI:0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65[95%CI:0.55-0.76]; p<0.0001).
Currently, MSD is continuing to explore the treatment potential of Keytruda across various settings and stages of gastrointestinal cancers through its extensive clinical program, including gastric cancer, hepatobiliary cancer, esophageal cancer, pancreatic cancer, colorectal cancer, anal cancer, and more.
Esophageal cancer is a particularly difficult cancer to treat, starting from the inner layer of the esophagus (mucosa) and growing outward. There are two main types of esophageal cancer: squamous cell carcinoma and adenocarcinoma. Globally, esophageal cancer is the seventh most common...DiagnosisCancer, and the sixth leading cause of cancer-related deaths. It is estimated that in 2018, there were over 572,000 new cases of esophageal cancer worldwide, with nearly 509,000 deaths. In China, esophageal cancer is the fifth most common cancer and the fourth leading cause of cancer-related deaths, with 90% of cases being squamous cell carcinoma.
Keytruda belongs to the PD-(L)1 tumor immunotherapy, which helps detect and combat tumor cells by enhancing the ability of the human immune system. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating potentially impactfulTumorT lymphocytes of cells and healthy cells.
As of now, globally, there have been more than 10 PD-(L)1TumorImmunotherapy has been approved for marketing, with Keytruda leading the field. It has received approvals for multiple treatment indications, and its global sales reached $14.38 billion in 2020, marking a 30% increase from the previous year.
MSD has the largest immuno-oncology clinical development program in the industry, with over 1,500Clinical TrialInvestigating Keytruda in various typesTumorand its role in the treatment context. The Keytruda clinical program aims to understand the drug's role in cancer and factors that may predict which patients will benefit from Keytruda treatment, including exploring several differentBiomarker. (Bioon.com)