Dr. Roy S. Herbst, Director of the Yale Center for Cancer, summarized the clinical benefits of immunotherapy in the treatment of lung cancer. The tumor immunotherapy referred to by Herbst is still limited to immunosuppressive antibodies: anti-PD-1 antibodies and anti-CTLA 4 antibodies. Currently, these antibodies are only approved by the FDA for the treatment of advanced melanoma. Last week, Squibb announced that the US FDA accepted its anti-PD-1 monoclonal antibody Opdivo sBLA and granted priority review status. The PDUFA date was set to June 22 this year. The ten points of the summary summarized by Dr. Herbst are arranged in order, from ten to one:
10) These drugs are really effective for patients with lung cancer and can be considered as breakthroughs. Primarily based on sustained effective time, Dr. Herbst even believes that these drugs are better than the targeted anti-EGFR agents. Because EGFR inhibitors produce resistance earlier than tumor vaccine therapy. However, his conclusions were limited to the clinical manifestations of the open clinical phase (Merck's anti-PD-1 antibody keytruda) and clinical phase II (Opdivo). Among them, Opdivo has a median survival time of 8 months for the overall survival of the cancer, and nearly half of the patients have lived for one year. This is an amazing result.
9) What are the appropriate clinical endpoints? In general, the FDA tends to use the overall survival as the gold indicator, and some drugs are approved through progression-free survival. For immunotherapy, some patients have delayed response, Dr. Herbst believes that patients The rate of immunization for treatment should be considered, but whether it should exceed 50%? It is not certain.
8) The efficacy of these immune whistle antibody antibodies varies. For antibodies of the same target, antibody affinity is different, and antibody-mediated cell killing power is also different. So the best comparison is the head-to-head clinical trial results.
7) The side effects of these antibody drugs are different compared to traditional chemotherapy. The side effects of antibodies seem to be related to the tail of inflammation, such as colitis, nephritis, pneumonia, hepatitis and so on. There are also a few central nervous system lesions associated with autoimmunity. Some lesions associated with the endocrine system have also attracted attention, such as the pituitary gland, thyroid gland, adrenal gland, and the like. These are some of the commonalities of the side effects of immunotherapy antibody drugs.
6) Biomarker detection response. Not all patients are effective for immunotherapy, so the selection of biomarkers to select patients is an important part of the assessment. Unfortunately, there are no recognized biomarkers, which is a mess in the words of Dr. Herbst. This is the direction of the joint efforts of the pharmaceutical industry and basic research.
5) The leading force of science. Lung cancer is a progressive disease, a tumor contains a variety of genetic code variants, biopsy and immune monitoring is very important, from the biopsy after treatment before the treatment will get dynamic information, such as lymphocytes in the tumor infiltration and response rate Relevance and so on.
4) Dose and dosing cycle. Is it a year or two? Whether the relapsed patients are still in use is still inconclusive.
3) Joint action. Tumor immunotherapy will certainly be combined with chemotherapy, molecular targeted therapy, and even immune checkpoint antibodies. For example, the combination of anti-PD1 antibody and anti-CTLA4 antibody shows that the synergistic effect is different for each patient, and the immunomodulatory function of each checkpoint is different.
2) Immunotherapy as a first-line, second-line, third-line, and fourth-line medication, Dr. Herbst believes that this is a completely correct option. After all, immunotherapy has different effects in different tumors. Currently, the focus is on melanoma, lung cancer, and kidney. Cellular kidney cancer.
1) This is a game. Although Merck won the first game in the US market, Keytruda became the first anti-PD-1 monoclonal antibody approved by the FDA, but it has just been learned that the US FDA has approved Bristol-Myers Squibb's Opdivo for the treatment of previous platinum-based preparations. Progressive, metastatic squamous non-small cell lung cancer patients. Of course, no matter who wins, the patient is the biggest winner.
(Bio Valley Bioon.com)
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