First-line immunotherapy for esophageal cancer! Mercedon Keytrud Plus Chemotherapy Program Receives FDA Priority Review: Will Become a New Standard for First-Line Treatment!

December 18, 2020 // -- Merck . Co) recently announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of a supplemental biologics license application (sBLA) for the anti-PD-1 therapy Keytruda (Corida, generic name: pembrolizumab, Pabliju monoanti).
the sBLA seeks approval for Keytruda combined platinum and fluorouracil-based chemotherapy, a first-line treatment for patients with local late-stage non-excisive or metastatic esophageal cancer and gastroesophageal junction (GEJ) cancer.
Currently, Keytruda is approved in the United States, China, and Japan as a single-drug therapy for second-line treatment of patients with relapsed localized late stage or metastatic esophageal squamous cell carcinoma (ESCC) with tumor expression PD-L1 (combined positive score (CPS) ≥10).
, through its extensive clinical program, is continuing to study Keytruda's therapeutic potential in a variety of environments and stages of gastrointestinal cancer, including stomach cancer, liver and bile cancer, esophageal cancer, pancreatic cancer, colorectal cancer, and cancer.
the sBLA is based on data from key Phase 3 KEYNOTE-590 trials.
the trial evaluated the first-line treatment of patients with local late-stage non-excisive or metastatic esophageal cancer and GEJ cancer with Keytruda combined chemotherapy (cisplatin-5-fluorouracil ( 5-FU) .
results were presented in September this year at the virtual conference of the European Society of Medical Oncology (ESMO) in 2020.
results showed that Keytruda plus chemotherapy: (1) significantly extended total lifetime (OS) and reduced the risk of death by 27% (HR-0.73; 95% CI:0.62-0.86; p<0.0001) compared to chemotherapy in the entire study group (INTENTIONAL) ;( 2) Significantly extended progression-free survival (PFS), reduced the risk of disease progression or death by 35% (HR=0.65; 95% CI:0.55-0.76; p<0.0001) ;(3) significantly improved objective mitigation rate (ORR: 45.0% vs 29.3%).
the study, Keytruda's security is consistent with previous reports.
esophageal cancer is an invasive and devastating malignancy with a high mortality rate and few treatment options other than chemotherapy.
for newly diagnosed, previously untreated patients, there is an urgent need for progress in treatment.
Based on keyNOTE-590 trial results, Keytruda was the first anti-PD-1 therapy to show superior OS, PFS, or ORR efficacy compared to current standard chemotherapy, regardless of tumor histology or PD-L1 expression status.
keytruda has the potential to change the current treatment model for patients with stage-stage, non-removable or metastatic esophageal or esophageal gastric junction cancer in the first line of treatment. Dr Vicki Goodman, vice president of clinical research at
Mercado Research Laboratory, said: "Newly diagnosed patients with esophageal and GEJ cancer face an invasive disease with poor prognosis, although treatments are currently available.
look forward to working with the FDA to bring new options to frontline patients.
" esophageal cancer (Photo: medindia.net) KEYNOTE-590 is a randomized, double-blind Phase III trial (NCT03189719) with 749 cases of local advanced or metastatic esophageal cancer (including esophageal adenocarcinoma and esophageal squamous cell carcinoma (ESCC)) and esophageal squamous stomach (GEJ) Siew 1 adenocarcinoma patients.
, these patients were randomly assigned to receive Keytruda plus chemotherapy, placebo plus chemotherapy as first-line therapies.
end points of this study are OS and PFS, and secondary endpoints include ORR, mitigation duration (DOR), and security.
OS data: At the first interim analysis, the medium follow-up was 10.8 months, compared to placebo, and Keytruda plus chemotherapy was randomized in all patients (middle OS: 12.4 months vs 9.8 months; HR was 0.73 . ESCC patients ;p<0.86) ;p<0.0001), tumor expression PD-L1 (CPS≥10) (medium OS: 13.9 months vs 8.8 months; HR=0.57 (95%CI:0) .43-0.75;p<0.0001), ESCC patients (medium OS: 12.6 months vs 9.8 months;p Patients with tumor expression PD-L1 (CPS≥10) (medium OS: 13.5 months vs 9.4 months; HR=0.62 (95% CI:0.49-0.78) ;p< OS results in 0.0001).
PFS data: Keytruda plus chemotherapy in all randomized patients compared to placebo (medium PFS: 6.3 months vs 5.8 months; HR=0.65 (95% CI:0.5) 5-0.76;p .lt;0.0001), ESCC patients (medium PFS: 6.3 months vs 5.8 months; HR -0.65 ( 95%) CI:0.54-0.78) patients with ;p-lt;0.0001), tumor expression PD-L1 (CPS≥10) (medium PFS: 7.5 months vs. 1 Significantly better PFS results were shown in 5.5 months;HR=0.51 (95%CI:0.41-0.65) ;p<0.0001).
ORR and DOR data: Keytruda plus chemotherapy showed better ORR data (45.0% vs 29.3% ;p<0.0001) and DOR data (medium DOR: 8.3 months vs 6.0 months) compared to placebo.
: Treatment-related adverse events (TRAEs) caused 19.5 percent of patients in the Keytruda plus chemotherapy group and 11.6 percent of patients in the chemotherapy group to stop taking the drug.
71.9% of patients in the Keytruda plus chemotherapy group and 67.6% of the patients in the chemotherapy group had level 3 to 5 TRAE.
9 cases in the Keytruda plus chemotherapy group and 5 treatment-related deaths in the chemotherapy group.
-mediated adverse events at any level occurred in 25.7 percent of patients in the Keytruda plus chemotherapy group and 11.6 percent in the chemotherapy group.
esophageal cancer is a particularly difficult cancer to treat, starting from the inner esophageal layer (mucous membrane) and growing outwards.
there are two main types of esophageal cancer: squamous cell carcinoma and adenocarcinoma.
, esophageal cancer is the seventh most commonly diagnosed cancer and the sixth most common cause of death.
estimates that in 2018, there will be more than 572,000 new cases of esophageal cancer worldwide and nearly 509,000 deaths.
the United States, 185,000 new cases of esophageal cancer will be diagnosed and 16,000 people will die from the disease by 2020.
, esophageal cancer is the fifth most common cancer and the fourth most common cause of death, with 90% of esophageal cancers being squamous cell carcinomas.
is a PD-(L)1 tumor immunotherapy that helps detect and fight tumor cells by improving the body's immune system.
Keytruda is an humanized monoclonal antibody that blocks the interaction between PD-1 and its mediators PD-L1 and PD-L2, activating T lymphocytes that may affect tumor cells and healthy cells.
To date, more than 10 PD-(L)1 oncology immunotherapy treatments have been approved worldwide, and Keytruda is a leader in this field, with more than 20 therapeutic adaptations approved, with global sales reaching $11.1 billion in 2019, up 58% from the previous year.
a recent report by
pharmaceutical market research agency, predicts that Keytruda will reach $16.8 billion in global sales in 2021, making it the world's second-best-selling drug after Humira, which is expected to sell $20 billion in 2021.
has the largest clinical development program in the industry for immuno-oncology, and more than 1,300 clinical trials are currently investigating Keytruda's role in multiple types of tumors and treatment backgrounds.
Keytruda Clinical Program aims to understand the role of the drug in cancer and the factors that may predict patients to benefit from Keytruda treatment, including exploring several different biomarkers.
origin of the original article: FDA Grants Review to Merck's Supplemental Biologics License application for KEYTRUDA® Plus Processy as First-Line Treatment for Locally Advanced Unreectable or Metastatic Esophageal and Gastroesophageal Cancer <!--/ewebeditor>