FAQ Frequently Asked Questions about the cancer immunotherapy

FAQ – Frequently Asked Questions

FAQ General

Immunotherapies are becoming more popular. Why is it that many people, even some doctors, do not know about this type of therapy?

Even for experts it is difficult to keep abreast of all current developments. Medicine is very much rooted in tradition and it often takes decades for new therapies to be accepted and generally accessible.

This is especially relevant when a groundbreaking new idea is being implemented. In traditional treatments, the doctor tries to “beat the cancer” with chemotherapy, surgery, or radiation. Immunotherapies, on the other hand, aim to put patients in the position to fight the cancer themselves through activating the immune system.

Immuno-oncology is a relatively young science providing many new research findings. That is why doctors need to update their knowledge continuously. This can be very demanding, but also gives the doctors the opportunity to better adapt the therapy to their patients and their tumors.

The success of immuno-oncological therapies complement and change the current therapy options. For a more widespread success, these forms of personalized therapy need to be implemented more in practice. However, for this to happen, the right structures and preconditions need to be created. This requires a certain amount of time.

What are the advantages of immunotherapy over classic oncological procedures?

It is commonly known that surgery, chemotherapy, and radiation also damage the healthy cells of the body. That can lead to serious side effects. The IOZK Immunotherapy, on the other hand, is targeted – only malignant tumor cells are attacked. Due to this, there are virtually no side effects.

Radiation and chemotherapy damage cells that divide quickly, however, they are not effective against “dormant” tumor stem cells. Thus, it can be presumed that the therapy is only effective during the course of treatment. As, for example, the hair starts growing again after the end of chemotherapy, so too can tumor cells start growing again. In contrast, the IOZK Immunotherapy can lead to the formation of an immunological memory, which leads to continuing protection as is known, for example, from vaccinations. It is also potentially active against tumor stem cells.

Is immunotherapy effective against all types of cancer? Are there cancers that respond especially well?

In principle, an immunotherapy is effective for the treatment of all malignant tumors: the immune system can reach tumor cells in all tissues and organs. However, the efficacy is not researched equally well for all types of cancer. Immunotherapies have thus far been primarily studied in cancers where no good, effective conventional form of treatment is available, such as malignant melanoma and glioblastoma.

Are immunotherapies also available at universities or through clinical studies?

Different types of immunotherapy are in clinical trials worldwide. In order to establish the effectiveness, the progression of the disease in two groups of patients is compared: one group that only receives the conventional treatment method, and one group that additionally receives the immunotherapy. That means that participants in a (double) blind study cannot be certain that they are actually receiving the immunotherapy.

There are not suitable clinical trials for all diseases and usually there are several exclusion criteria.

To search for suitable clinical trials visit: clinicaltrials.gov

What is an “individueller Heilversuch”?

An “individueller Heilversuch” is a form of compassionate-use treatment permitted in Germany. It represents the therapeutic freedom medical doctors may practice in Germany. It is a procedure that may be carried out for the benefit of the patient if other treatment methods have been exhausted or at an earlier stage at the patient’s request. Contrary to clinical studies, the primary goal is not gather results on the effectiveness of the therapy, but rather to provide the individual patient with the best-possible treatment.

FAQ about the IOZK Immunotherapy

Some immunotherapies have already been approved. How do they differ from the IOZK Immunotherapy?

Several antibodies have been approved in Europe, especially the so-called checkpoint inhibitors. These attach to specific receptors and support an existing immune reaction against the tumor cells. However, such an immune response does not exist in all patients. Accordingly, this therapy is only effective in about 20% of patients. For some types of cancer, such as lung cancer, this is higher success rate than with the currently used chemotherapies. That is why checkpoint inhibitors are considered as the best treatment for this disease if the relevant receptors are present.

However, for around 80% of patients, checkpoint inhibitors are not effective due to the non-existent immune response against the tumor cells. The IOZK Immunotherapy promotes the development of such an immune response and can thus improve the effectiveness of checkpoint inhibitors. This idea is currently being discussed worldwide and is being tested in clinical trials.

When is the best time for the IOZK Immunotherapy?

The IOZK Immunotherapy can be carried out at any time after diagnosis of a tumor. Current findings indicate that an immunotherapy during the early stages of a tumor show the best long-term results.

The best time to contact the IOZK prior to the first operation. It is beneficial if the patient’s own tumor material is used for the production of antigens.

There are indications that an immunotherapy is more effective the smaller the tumor mass is, i.e., in the early stages or after an operation. However, an increasing number of successes are being noted with patients at more advanced stages.

In principle, the IOZK Immunotherapy can be combined with any conventional treatment option. However, immunosuppressive therapies (e.g., cortisone, radiation, chemotherapy) can limit the functioning of the immune system temporarily, making it important to coordinate the different therapies appropriately.

Should the immune cells resist an immune response, an adjuvant PD-1 antibody therapy (approved in 2015) can be useful.

How much does the therapy cost? Is it covered by health insurance?

The costs of therapy depend on the individual expense of vaccine production, the respective extent of treatment and the course of the disease. Which interventions are suitable for a patient is discussed by the medical team in a tumor conference. The treatment options and the associated costs in each particular case are discussed with the patient.
The level of costs is due to the enormous personnel and technical effort involved: an individual drug is produced for each patient in strict compliance with the legal requirements under the German Drug Law (AMG).
Since the therapy applied to each patient is individual, the costs vary, sometimes considerably. From experience, we can give the following fees for orientation:
– for the laboratory tests required prior to treatment between € 3,500 and € 5,000.
– for an IO-VAC® vaccination cycle between € 23,000 and € 28,000 (At least two vaccination cycles are necessary for one treatment.)
– for a five-day treatment session to induce immunogenic cell death (e.g., as an adjuvant treatment during chemotherapy or as maintenance therapy after the IO-VAC® vaccination cycles have been performed) between € 6,000 and € 11,000.
These amounts do not include any additional costs for individual medication (infusions). The patient will be liable for the cost of treatment, regardless of insurance reimbursement.
The costs for diagnostics and therapy may possibly be reimbursed by private health insurances (depending on the contract concluded). Immunotherapy is not covered by German statutory health insurance. However, under certain circumstances, the costs may be covered upon written application in individual cases.

What does a course of treatment usually look like? How long will it take?

The progression of a cancer and the immune system are dynamic processes and this needs to be taken into consideration during treatment. That is why the IOZK Immunotherapy is tailored to each individual patient.

If required, the IOZK Immunotherapy can be combined with other forms of therapy, such as radiation or chemotherapy. Contrary to radiation or chemotherapy, which follow a standard protocol, the length and form of the IOZK Immunotherapy is composed according to the needs of the individual patient.

The following standard course of treatment can be used as a guide. It contains
two vaccination cycles and takes around 5 weeks.

Further information can be found here: Course of Treatment

Does the therapy have any side effects? If yes, what are they?

In our experience, and according to many scientific publications, immunotherapy is very well tolerated and can, in contrast to conventional therapies, maintain, or even improve, the quality of life. In the many years that we have worked with this therapy, we have never experienced any serious side effects, nor have they been described in literature.

One common side effect we have observed are flu-like symptoms that develop the day after the first Newcastle Disease Virus application. This is harmless and can be easily treated.

How many patients have been treated to date? What are the results?

Over the last years, we have treated over 2.000 patients with different types of tumors at the IOZK. Each treatment was optimized according to the individual patient’s needs.

Due to the high degree of personalization of the treatment, it is difficult to compare the progression of the disease and the patient data. Thus it is not possible to conduct a statistical analysis regarding the effectiveness of the treatment, as we are not performing a clinical trial. However, there is ongoing international research on immunotherapies that shows very promising results.

For example, in 2018, an international study on the aggressive brain tumor glioblastoma showed that the overall survival of patients who received a dendritic cell vaccine was doubled when compared to the standard therapy. From our experience with patients with glioblastoma, we know that the IOZK Immunotherapy increases overall survival in a similar order of magnitude.

The more specific research methods are becoming, the clearer it is, that tumors are very different regarding their biological behavior and the reaction to certain therapies. Depending on the genetic profile, considerable differences can be found within the same type of cancer: breast cancer is not simply breast cancer. Traditional studies on the effectiveness are based on comparing large groups of patients receiving different treatments. The more we know about the differences within the same type of cancer, the more difficult it is to conduct such studies and the statistical results are questionable.

The IO-VAC® vaccine: What is meant by “advanced therapy medicinal product”?

The vaccine IO-VAC® is classified as an advanced therapy medicinal product (ATMP). ATMPs are divided into three product groups: somatic cell therapy products, gene therapy products, and tissue engineered products.

IO-VAC® is a somatic cell therapy with tissue-engineered components (tumor components) in combination with an oncolytic virus. The medicinal product consists of the patient’s own living dendritic cells (DCs) and a viral oncolysate (VOL). The cells used are generated from the patient’s blood samples, processed in the laboratory (their function is modified) and subsequently administered to the patient.

For more information see: The vaccine IO-VAC®

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