Improved disease progression-free survival! FDA approves immune drug Pembrolizumab combination therapy for advanced cervical cancer
FDA approves immune drug Pembrolizumab combined with chemotherapy and radiotherapy for advanced cervical cancer
Cervical cancer is an important threat to contemporary women’s health. According to WHO data, more than 300,000 women die from cervical cancer every year worldwide. Once cervical cancer progresses to an advanced stage, the survival rate is less than 20%. “Immunotherapy” that can awaken the body’s immune system and restore the ability of T cells to recognize and attack cancer cells is regarded as a treatment hope for various difficult-to-treat advanced cancers.
The US FDA officially announced in January this year (2024) that it has officially approved the immunotherapy drug Pembrolizumab to be combined with chemotherapy and radiotherapy for the treatment of advanced (III-IVA) cervical cancer that has not received surgery, radiotherapy or chemotherapy. This is the 40th tumor-related indication for Pembrolizumab, covering 19 cancer types.
According to information from the U.S. FDA, the large-scale clinical trial KEYNOTE-A18 conducted a randomized controlled trial on 1,060 cervical cancer patients who had not undergone surgery or received chemotherapy or radiotherapy. The results showed that the immune checkpoint inhibitor Pembrolizumab combined with chemotherapy and radiotherapy can help patients with advanced cervical cancer. The overall survival is not affected by the amount of PD-L1 expression. Among patients in stage 3-4A, the disease progression-free survival (PFS) improved by 41%. However, neither the control group nor the experimental group in this trial reached the median progression-free survival, and the overall survival must also be sustained. track.
Mechanism of action of PD-1 immune checkpoint inhibitors that activate the human immune system
PD-1 and CTLA-4 are “immune checkpoints” on T cells. Cancer cells will express PD-1 ligands (PD-L1 and PD-L2) that bind to PD-1 on T cells and are transmitted through pathways. The message inhibits the immune surveillance effect of active T cells on tumors and causes immune cells to lose their ability to recognize and kill tumors. Immune checkpoint drugs achieve the purpose of anti-tumor treatment by activating the body’s own immune system.
The so-called “immunotherapy” immune checkpoint inhibitors, including PD-1 drugs (pembrolizumab) and PD-L1 drugs (atezolizumab), are monoclonal antibody drugs that can block the combination of PD-1 and PD-L1. However, most past studies have shown that the average response rate to immunotherapy is only about 20%. Tumors with higher PD-L1 expression generally have a higher therapeutic response to immune check inhibitors. Some cancer treatment guidelines therefore regard the amount of PD-L1 expression as the basis for first-line treatment selection. Other biomarkers that influence immunotherapy response include microsatellite instability of tumor genes, the amount of tumor mutations, and the genetic sequencing of patient T cells.
Treatment response rates vary among individuals Possible side effects of PD-1 immune checkpoint inhibitors
Overall, immune checkpoint inhibitors bind to PD-1 and block its interaction with PD-L1 and PD-L2, thereby relieving the inhibition of immune responses (including anti-tumor immune responses) mediated by the PD-1 pathway. . In mouse tumor model experiments, blocking PD-1 activity reduced tumor growth. Currently, pembrolizumab has been approved for indications including melanocytoma, non-small cell lung cancer, classic Hodgkin’s lymphoma, head and neck leukocyte carcinoma, urothelial cancer and gastric cancer.
However, the response rate of immune checkpoint inhibitors varies from person to person, and the risk of side effects is about 10% to 20%. Therefore, its safety must be monitored during treatment. Taking pembrolizumab as an example, adverse side effects that may occur during treatment include nausea and diarrhea. , vomiting, urinary tract infection, fatigue, hypothyroidism, constipation, decreased appetite, weight loss, fever, abdominal pain, hyperthyroidism, difficulty urinating, rash and pelvic pain, etc. If same-day treatment requires chemotherapy and radiation therapy, the immune checkpoint inhibitor should be administered before chemotherapy.
Source:
FDA Expands Pembrolizumab Approval in Cervical Cancer
FDA Approves Pembrolizumab for Stage 3/4a Cervical Cancer
FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer
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