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Keytruda(Pembrolizumab): The hope of patients with esophageal cancer may also be the hope of other cancer patients. On March 23, 2021, Merck announced that the US Food and Drug Administration has approved the company’s anti-PD-1 inhibitor Keytruda (generic name: Pembrolizumab) for use in combination with fluorouracil and cisplatin First-line treatment of locally advanced or metastatic esophageal cancer or gastroesophageal junction cancer.
This is the world’s first anti-PD-1 immune combination therapy approved by the US Food and Drug Administration for the treatment of this patient group.
What kind of medicine is “Keytruda”?
Keytruda is a humanized anti-PD-1 monoclonal antibody therapy, which can enhance the anti-cancer immune response of T lymphocytes by blocking the binding of PD-1 receptors to PD-L1 and PD-L2, thereby improving body immunity The ability of the system to detect and kill cancer cells.
Merck said that anti-PD-1 therapy is currently applicable to gastroesophageal junction cancer (tumors with the epicenter 1-5 cm above the gastroesophageal junction), which is not suitable for surgical resection or definitive chemoradiation therapy.
This approval is based on the results of the Phase 3 KEYNOTE-590 trial. KEYNOTE-590 is a randomized, double-blind phase III trial (NCT03189719), enrolling a total of 749 locally advanced or metastatic esophageal cancers (esophageal adenocarcinoma or squamous cell carcinoma or Siewert type 1 adenocarcinoma at the esophageal-gastric junction) patient. In the study, these patients were randomly assigned to receive Keytruda + chemotherapy, placebo + chemotherapy as first-line therapy.
Compared with fluorouracil and cisplatin alone, the overall survival rate of Keytruda combined with fluorouracil and cisplatin in the trial (the time from the time the patient was confirmed to have the disease to death due to any cause) was reduced by 27%.
For progression-free survival (patients are treated, randomly selected a certain time until tumor recurrence or death due to various causes, the total survival time of the patient), Keytruda combined with fluoropyrimidine and cisplatin is compared with fluoropyrimidine and cisplatin alone , The risk of disease progression or death is reduced by 35%.
Up to now, many PD-(L)1 tumor immunotherapies have been approved globally. Keytruda is the leader in this field. In addition, Merck is continuing to study Keytruda’s gastrointestinal effects through its extensive clinical projects. The therapeutic potential of multiple environments and stages of tract cancer, including gastric cancer, hepatobiliary cancer, esophageal cancer, pancreatic cancer, colorectal cancer and anal cancer.
What does “Keytruda” stand for?
Dr. Roy Baynes, Head of Global Clinical Development at Merck Research Laboratories, said: “Esophageal cancer is a devastating malignant tumor that grows from the inner layer of the esophagus (mucosa) and is divided into squamous cell carcinoma and adenocarcinoma. Globally Within the scope, esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of cancer death, with a high mortality rate, and there are few other treatment options except chemotherapy.
Immunotherapy is the fifth pillar of cancer treatment besides surgery, radiotherapy, chemotherapy and targeted therapy. The anti-cancer progress report released by the American Association for Cancer Research pointed out that as of July 31, 2020, at least one immunotherapy can be used to treat 16 types of cancer, including lung cancer, liver cancer, stomach cancer, and breast cancer.
The expansion of immunotherapy from second-line and third-line therapy to first-line and adjuvant therapy will bring the possibility of cure for patients at an earlier stage of cancer development and prolong their lives. This is also the focus of immunotherapy development.
In 2014, based on the “KEYNOTE-181 and KEYNOTE-180” clinical trials of 628 melanoma patients, the U.S. Food and Drug Administration approved Keytruda for the treatment of advanced melanoma for the first time, and has since been approved for lung cancer and head and neck cancer. , Gastric cancer, hepatocellular carcinoma and more than 20 indications.
In 2019, the U.S. Food and Drug Administration approved Keytruda for the second-line treatment of esophageal cancer, and it has been launched in China and Japan.
At this point, esophageal cancer therapy has officially entered the age of immunity.
Keytruda is just the beginning, Our research on esophageal cancer never stops
After 2010, immunotherapies represented by PD-1/PD-L1 inhibitors have risen rapidly, and a variety of second-line immunotherapies for esophageal cancer have emerged, such as Bristol-Myers Squibb (NYSE: BMY) nivolumab. Monoclonal antibody) and Hengrui Medicine’s Karelizumab (Erica).
However, the first-line treatment for esophageal cancer is still in a blank period. Therefore, Keytruda is approved for the first-line treatment of locally advanced or metastatic esophageal cancer or gastroesophageal junction cancer. It will be the medical profession to promote esophageal cancer immunotherapy from the second-line treatment. A milestone in first-line treatment.
But our exploration in the field of esophageal cancer is far from stopping. Dr. Roy Baynes, head of global clinical development at Merck Laboratories, said, “We will be committed to patient-centered and continue to develop innovative methods to extend their lives.”
(source:internet, reference only)