Imlygic - Talimogene Laherparepvec

What is Imlygic - Talimogene Laherparepvec and what is it used for?

Imlygic is a cancer medicine used to treat adults with melanoma (a form of skin cancer) that cannot be surgically removed and has spread to other parts of the body (except for bones, lungs, brain and other internal organs).

Imlygic is a type of advanced therapy medicine called a "gene therapy product", which is a type of medicine that works by introducing genes into the body's cells. It contains the active ingredient talimogene laherparepvec.

How is Imlygic used - Talimogene Laherparepvec?

Treatment with Imlygic should be started and given under the supervision of a doctor experienced in treating cancer.

Imlygic is available as a solution for injection in two different concentrations. It is given by injection into melanomas. The lowest concentration of Imlygic is used to administer the first dose, while the highest concentration is used for the subsequent doses. The second dose is administered three weeks after the first dose and the treatment is continued every two weeks for at least six months, unless the doctor believes that the patient is not receiving any benefit from the medicine. The volume of medicine to be injected depends on the size of the tumor and the number of tumors to be treated. For more information, see the summary of product characteristics (included with EPAR).

How does Imlygic - Talimogene Laherparepvec work?

The active ingredient in Imlygic, the talimogene laherparepvec, is a type of gene therapy called "oncolytic virus". It derives from the weakened herpes simplex virus 1 (the cold sores virus). This virus has been modified to infect melanoma cells and multiply within them. Imlygic uses the internal organization of melanoma cells to multiply, overwhelm and eventually kill tumor cells. Although Imlygic can enter healthy cells, it is not designed to multiply within them.

Furthermore, Imlygic induces the production of a protein called GM-CSF by the infected melanoma cells. This protein stimulates the patient's immune system (the body's natural defenses) to recognize and destroy melanoma cells.

What benefits of Imlygic - Talimogene Laherparepvec have been shown in studies?

Imlygic was examined in a main study involving 436 patients with inoperable melanoma that had spread to other parts of the body (except for bones and brain). The 24-month study compared Imlygic and GM-CSF injected subcutaneously. The main measure of effectiveness was the percentage of patients who responded to the treatment by maintaining this response for at least six months, before their health deteriorated or the need for another therapy. Treatment response was defined as a reduction of at least 50% of melanoma signs. Taking into consideration the subgroup of patients in the study (249 patients) who did not present with widespread lung disease or other internal organs, 25% (41 of 163) of patients treated with Imlygic had a prolonged response to treatment compared to 1% approximately (1 in 86) of patients treated with GM-CSF.

What are the risks associated with Imlygic - Talimogene Laherparepvec?

The most common side effects with Imlygic (which may affect more than 1 in 4 people) are tiredness, chills, pyrexia (fever), nausea, flu-like illness and pain at the injection site. These side effects were largely mild or moderate in severity. The most common serious side effect (which affected about 2 people in 100) was cellulite (infection of the upper layers of the skin). Imlygic contains a herpes virus that can reactivate later, causing herpes infections such as cold sores. In patients who have a weak immune system (eg, HIV patients), Imlygic can cause a more widespread disease. Imlygic must not be used in patients with a severely compromised immune system, as the possible reactivation of the virus could cause herpes infection to spread to other parts of the body. For the full list of limitations and side effects reported with Imlygic, see the package leaflet.

Why has Imlygic - Talimogene Laherparepvec been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) has highlighted that Imlygic is a therapy based on an innovative mechanism of action that could be a valid addition to existing therapies for inoperable advanced stage melanoma, a sector with need unsatisfied medical records. Patients with inoperable melanoma spread to other parts of the body (except bones, brain and lungs) have shown prolonged reduction of melanoma after treatment with Imlygic, but it is not yet known whether this benefit will result in greater survival. Regarding safety, Imlygic was relatively well tolerated and the side effects were largely mild or moderate. The CHMP therefore considered that the benefits of Imlygic outweigh the identified risks and recommended that they be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Imlygic - Talimogene Laherparepvec?

A risk management plan has been developed to ensure that Imlygic is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imlygic, including the appropriate precautions to be followed by healthcare professionals and patients.

The company has implemented a controlled distribution program at qualified centers to ensure compliance with the requirements for low-temperature storage and handling and to control distribution to patients. As part of this program, the medicine will only be provided to physicians who have received the appropriate educational material on the risk of herpes infection, especially in patients with compromised immune systems, on the risk of transmitting the virus to health professionals or other close subjects contact with the patient (accidental exposure) and the necessary precautions to be taken for the administration and disposal of the product. Patients will also receive educational material and a patient's medical alert card with information on the risks associated with the medicine and how to avoid accidental exposure to Imlygic.

The company will also conduct three studies to further characterize the benefits and risks of Imlygic, including a study of Imlygic in patients with advanced melanoma that can be surgically removed.

Further information is available in the summary of the risk management plan.