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THE CHALLENGES

Although scientists are able to develop different types of immunotherapy, they still face several, major challenges when advancing the field of cancer immunotherapy.

Unpredictable Effects

When patients are treated with immunotherapy, it is found that a small amount of people responded to the treatment. In addition, immunotherapy is effective for certain types of cancer, so immunotherapy can not be used to treat all cancers. Some of the reasons why every patient does not respond to immunotherapy are because tumors vary, there are different types of cancer, and cancer cells have the ability to prevent an immune response. In addition, tumors have different types of mutations, so immunotherapies need to be modified to treat a specific cancer in patients. Researchers are challenged to create effective drugs and uncover the different genetic mutations, “cancer pathways, and immune checkpoints.”

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Necessity of Predictive Biomarkers

It is important to have predictive biomarkers because they will determine whether or not a patient will respond to the immunotherapy. It is a challenge because it is difficult and takes a long time to recognize if a biomarker is effective or not. In addition, patients have specific biomarkers.

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Clinical Trials

Clinical trials for cancer immunotherapy have to be developed when studies show positive results for the effectiveness of drugs in patients who have specific biomarkers. The drug would have to undergo phase 3 of a clinical trial, where data is collected and presented to FDA for its approval of the drug. This would take several years.

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The image provides a brief summary about the stages needed to develop a drug. It also depicts how clinical trials are time-consuming.  1

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