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Immunotherapy Promises New Approach to Fighting Cancers, Business and Industry Trends Analysis

Bristol-Myers Squibb Co., Merck & Co. and Roche Holding AG, among others, are developing immunotherapy drugs to fight cancer.  The drugs are based on a strategy to stimulate and/or suppress the immune system in order to help the body fight cancer, infection, and other diseases, often with relatively few side effects.  Some types of immunotherapies only target certain cells of the immune system.  Others affect the immune system in a general way.  Types of immunotherapy include cytokines, vaccines and certain monoclonal antibodies.  A more recent class of these drugs is called checkpoint inhibitors which block normal proteins on cancer cells.  Advancements in genetic sequencing and analysis are aiding significant advances in immunotherapy.
A key strategy in fighting cancer is to use immunotherapy techniques to encourage the body's own immune system to aggressively locate and attack cancer cells.  Specifically, T-cells, a type of white blood cell, often are unable to fight malignant cells because of proteins in the cancer that bind to T-cell receptors (called PD-1 receptors), effectively blocking the T-cells’ ability to do their jobs.  Immunotherapy drugs block the binding of the proteins to the PD-1 receptors, allowing the T-cells to find and attack the cancerous cells.  Oncologists report that the successful response rate to immunotherapy is about 20% across cancer types.
Bristol-Meyers was one of the first to offer an immunotherapy drug, Yervoy, which treats melanoma (skin cancer).  Another immunotherapy drug for melanoma is Merck’s Keytruda.  Former U.S. President Jimmy Carter was successfully treated for metastatic melanoma with Keytruda.
Another high-cost treatment is the use of CAR T-cell therapies (developed by Novartis AG and Juno Therapeutics, Inc.) for advanced leukemia.  Costs may fall as more drugs are approved and enter the marketplace.
The FDA approved the first immunotherapy for lung cancer in March 2015.  The drug is called Opdivo and was developed by Bristol-Meyers Squibb.  Opdivo is also known as Nivolumab and already has approval to treat advanced cases of melanoma.  The drug was approved by the EU Commission in 2015 for the treatment of certain types of lung cancer.  In 2016, the FDA approved Tecentriq, developed by Roche, to treat bladder cancer.  Another gene therapy bladder cancer treatment, Adstiladrin, was approved by the FDA in late 2022.
Significant progress has been made in the fight against cancer.  Efforts on a national scale to further this progress include the 21st Century Cures Act, a bipartisan Congressional effort in the U.S. to streamline clinical trials and reform the FDA’s regulation of emerging technologies.  Meanwhile, the National Cancer Institute is analyzing drug candidates that previously failed clinical trials to see if they may be of use in treating patients with genetic aberrations (the 10% who react differently in trials compared to the bulk of respondents).  Another initiative is the efforts of cancer centers such as Dana-Farber in Boston and the Moffitt Center in Florida to pool oncologic data and use computers to develop drug protocols based on the results.
Seagen, Inc. (formerly known as Seattle Genetics) is a biotech firm that develops and commercializes therapies to treat cancers.  Seagen’s therapies are based on antibody-drug conjugate (ADC) technology that utilizes the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells.  The company's lead product, Adcetris, has received approval for six indications to treat Hodgkin lymphoma and T-cell lymphoma.  Other approved products include Padcev for bladder cancer, Tukysa for breast cancer, and Tivdak for cervical cancer.  The company had several other oncology programs in pivotal trials or advanced research as of 2023.  These include versions targeting advanced prostate cancer, breast cancer, melanoma and lung cancer.  Seagen also licenses its antibody-drug conjugate technology to several leading biotechnology and pharmaceutical companies.  In March 2023, Seagen entered into a merger agreement with Pfizer, Inc. in a deal worth approximately $43 billion.
A big breakthrough in cancer is the development and testing of a liquid biopsy test to detect cancer from blood samples.  2014 saw the launching of Guardant Health’s liquid biopsy test which scans blood samples for small DNA fragments released by malignant tumors.  The Guardant360 test searches for any of 70 identified cancer genes, making it a far less invasive (and less expensive, at about $5,000 for cash-paying patients) procedure than standard biopsies.  Another breakthrough is the Galleri test, which, from a simple blood draw, can detect a signal shared by about 50 types of cancer with high accuracy.  The cost is only about $1,000.  People who receive a positive indication from the Galleri test can then go to a specialist for follow up and further analysis.
Immunotherapy was successfully used to treat a patient with metastatic breast cancer after she failed to respond to traditional chemotherapy and hormonal treatments.  Researchers at the National Cancer Institute (NCI) studied the woman’s tumors and identified 62 separate mutations in the malignant cells.  Her immune cells were evaluated to determine those capable of recognizing the mutations.  Those immune cells were replicated billions of times over and infused back into the patient.  She was in full remission 22 months after the treatment.  The technology is basically a blueprint of how targeting of mutations may be used to treat many types of cancer, including those of the colon and cervix.
CAR-T, Chimeric Antigen Receptor Cells:  In this advanced treatment for cancer, doctors remove millions of white blood cells called T-cells from the patient and insert new genes that enable the cells to fight malignancy.  A form of disabled virus may be used in the drug’s design, because the virus quickly and easily carries the inserted genetic material into the T-cells, which are reprogrammed to attack the cancerous cells.  The altered T-cells, called CAR-T for chimeric antigen receptor cells, are put back in the patient’s bloodstream via an intravenous drip.  Treatment may cause a violent reaction in the patient, including extremely high fevers and chills, but has been successful in achieving lasting remission in many patients, including children with acute leukemia and adults with leukemia and lymphoma.  (Unfortunately, some clinical trials have also resulted in patient deaths.  This risk may be well justified considering the high remission rates in patients who have not responded to other therapies for their potentially fatal cancers.  Some researchers believe safety can be improved by lowering CAR-T doses while combining the drugs with other therapies such as checkpoint inhibitors.)
CAR-T therapy is potentially a vast improvement over traditional chemotherapy.  Although chemotherapies have improved in recent years, they continue to indiscriminately kill both healthy cells and cancerous cells, with significant long-term side effects for the patient.  The revolutionary CAR-T treatment, in contrast, hits only the targeted cancerous cells.  That is, CAR-T therapies are designed to recognize a specific cancerous tumor antigen, bind to this target and then activate, creating a tremendous immune system response to kill the cancer.  Cancer remission rates of as high as 94% have been achieved in trials.  CAR-T is so promising and so effective that hundreds of these drugs are, or have been, in various stages of clinical trials, including drugs targeting lung or breast cancers.
One of the newest CAR-T drugs is Abecma, developed by Bristol-Myers Squibb Co. and bluebird bio, Inc.  It is used to treat multiple myeloma and was approved in March 2021.
Unfortunately, recently approved CAR-T drugs, such as Novartis’s Kymriah, approved in the U.S. in 2018, and Gliead/Kite Pharma’s Yescarta, approved in 2017, can cost more than $370,000 for the drugs alone, plus hundreds of thousands of additional dollars for the complete regimen of medical support and treatments required to complete the therapy.  Drug developers claim that they need to charge such high prices to gain a reasonable return on their investment in research and development.  Critics claim that the drug firms are simply charging the highest prices that they think the market will bear.
In mid-2022, the FDA approved Carvykti, a CAR-T treatment for blood cancer from Johnson & Johnson.  Developed initially in China, the drug, when tested in a U.S. study, found that 98% of the multiple myeloma patients treated with Carvykti had a notable reduction in the proteins that signal the presence of the disease, and 83% had a complete remission.  Carvykti was the sixth CAR-T therapy that had been approved by the FDA for use in the U.S. as of mid-2022.

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