Biomarkers will affect five major medical fields such as precision medicine

Release date: 2017-02-24

In 2016, Merck and Bristol-Myers Squibb's cancer immunotherapy drugs Keytruda and Opdivo had global sales of US$1.4 billion and US$3.8 billion respectively, and with the further expansion of indications and the publication of more in-depth test data on immunotherapy. It will surely attract more doctors and patients to choose this way to fight against tumor cells by stimulating the body's own immune system.

The success of these two therapeutic drugs has brought a lot of attention to the programmed death factor ligand 1 (PD-L1), but in actual drug treatment, these immune checkpoint inhibitors are only in some cancer patients. It has a prolonged effect of disease remission and survival, while for others, these drugs have almost no therapeutic effect. Studies have confirmed that although the relationship between the expression level of PD-L1 and disease response has not been clarified in detail, cancer patients with high PD-L1 expression do have higher disease remission. Therefore, in clinical practice, detection of PD-L1 can screen out potential drug treatment responders.

The expression level of the biomarker PD-L1 can predict the therapeutic effect. Similarly, in the biopharmaceutical industry, the role of biomarkers will become wider and wider, and it can be applied not only to the treatment of cancer, but also in other fields.

The following are the five major medical areas under the influence of biomarkers:

Precision medicine

Accurate medical treatment , which is targeted for individualized treatment through the acquisition of patients' special genetic properties, personal physique and lifestyle, is a long-term therapeutic goal of the medical community. However, for a long time, this goal has been a dream that is difficult to accomplish. With the development of human gene sequencing technology, the dream of precision medicine has become a reality, and the burden of treatment for patients has been greatly reduced.

Whether the patient is suffering from cancer or a rare disease, or a neurodegenerative disease like chronic traumatic encephalopathy, the relevant biomarkers can help clinicians and doctors better diagnose the corresponding patients. Not only is the diagnosis method simpler, but the target patients matched with the specific therapy can be screened by diagnosis, thereby achieving better clinical efficacy and prognosis, and has a greater therapeutic advantage than the traditional one-size-fits-all treatment.

2. Combination therapy

Immunotherapy is the hottest area of ​​research in the medical industry in the past three years. For all types of cancer patients, better treatment can be achieved through immunotherapy, and the medical community is very aware of this. Currently, hundreds of clinical trials of combined therapies are in full swing around the world, but finding matching patients before the trial delays the progression of these clinical trials.

The identification of biomarkers associated with specific tumor types is more representative of the value of combination therapy, which can be grouped into different treatment groups depending on the type of biomarker of the patient, and the clinician is thus aware of the basis of the patient's biomarkers. In addition, the administration of the combination therapy can be more targeted.

3. Companion diagnosis

Although diagnostic tests have a long history of detecting diseases such as bacterial infections, with the development of human gene sequencing technology, the field of laboratory diagnostic testing is undergoing a new transformation.

The accompanying diagnostic equipment for marketed drugs used to be rare in the past, but nowadays, it is common for pharmaceutical companies to develop a drug and follow the accompanying diagnostic equipment corresponding to the market.

When the diagnostic equipment was first put on the stage decades ago, the entire pharmaceutical industry held great doubts about it, mainly worried that the accompanying diagnostic equipment would differentiate patients and would reduce the sales of listed drugs. But such heavy drugs as Herceptin (trastuzumab for injection) and Gleevec (imatinib) have proved that this doubt is wrong and redundant.

4. Liquid biopsy

Liquid biopsy technology can detect tumors and cancer through a small tube of blood, which is a breakthrough technology for adjuvant therapy, and has gradually entered the clinical stage. This technology has very attractive development prospects, so many companies and investment institutions have entered the liquid biopsy development camp.

Compared with traditional tissue biopsy, liquid biopsy is a non-invasive blood test that monitors circulating tumor cells and circulating tumor DNA fragments released into the blood by tumors or metastases. At present, liquid biopsy technology is mainly used to select the treatment strategy for patients, to match the treatment method with the type of disease mutation, and to monitor the disease progression of patients with advanced cancer.

But Grail and GuardantHealth have pushed liquid biopsy technology to the early stages of disease detection. Grail, a subsidiary of sequencing giant Illumina, has developed biopsy technology that can be used to test screening for a variety of cancers without symptoms.

Although the use of liquid biopsy techniques for the screening of asymptomatic cancers still has a long way to go, the technology is well known for accelerating the inclusion of clinical trials. A large amount of capital is pouring into the field of liquid biopsy, and the next decade will be a critical period for a good harvest of liquid biopsy.

5. Rareness of cancer

Former US President Barack Obama first proposed a precision medical plan in 2015 to further strengthen the understanding of human genes and accelerate the development of precise treatments for each cancer individual.

Although today's US government has other policies to focus on, the 21st Century Healing Act unanimously passed by Congress last December will still support US medical innovation. Other "moon landing plans", like the former US Vice President Joe Biden's multi-billion dollar campaign to overcome cancer, will also bring industry breakthroughs in the next decade.

The propensity of government policies for medical development has increased confidence in the medical development that can truly treat diseases accurately. Targeted therapy has been around for many years, but it is only the science that has emerged and developed after revealing the genetic mystery of disease (such as cancer).

Optimized gene sequencing technology, cancer immunotherapy, and better diagnostic tools will make cancer treatment options more diverse and effective. It is not only the treatment of lung tumors or prostate tumors at the organ level, but also the molecular basis of treatment for specific genetic mutations.

The National Cancer Institute is currently conducting a large-scale clinical trial called MATCH that aims to use molecular-based mutation-based targeted drug therapy research instead of using approved indication-targeted drugs to treat related diseases. The American Society of Clinical Oncology is also conducting similar TAPURstudy trials.

Accurate and targeted treatments for specific diseases have far exceeded the concept itself, but it still takes a long way to go to see the actual benefits of precision treatment.

Source: Sina Pharmaceutical News

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