GAVRETO was studied to see if it was safe and effective in treating adults with RET+ metastatic non–small cell lung cancer (mNSCLC)
Clinical study background for GAVRETO:
What was measured in the clinical study?
- How many adults had their tumors shrink by at least 30% (a partial response) or completely disappear (a complete response)*
- How long their response to treatment lasted
*It is important to know that a complete response (which means all tumors have responded completely and disappeared) does not mean the cancer has been cured.
Who was included in the clinical study?
114 adults with RET+ mNSCLC, including:
27 adults who never had cancer treatment before
87 adults who had at least 1 cancer treatment in the past
of those 87 adults,
8 adults had tumors that spread to the brain. None had received radiation therapy within 2 months before the start of the study.
RET+=rearranged during transfection positive.
GAVRETO was effective in treating adults with RET+ mNSCLC
GAVRETO was approved based on the results shown below. However, the clinical study is ongoing to confirm benefit of GAVRETO.
In 27 adults who had never received cancer treatment before GAVRETO:
70%
saw their tumors shrink or disappear*
(19 out of 27 adults)
And of those adults who had tumor shrinkage, 58% (11 out of 19 adults) saw their response to treatment last for up to 6 months or longer.†
*It is important to know that a complete response (which means all tumors have responded completely and disappeared) does not mean the cancer has been cured.
In 87 adults who had received cancer treatment before GAVRETO‡:
57%
saw their tumors shrink*
(50 out of 87 adults)
And of those adults who had tumor shrinkage, 80% (40 out of 50 adults) saw their response to treatment last for up to 6 months or longer.†
*It is important to know that a complete response (which means all tumors have responded completely and disappeared) does not mean the cancer has been cured.
In 8 adults who had received cancer treatment before GAVRETO and had tumors that spread to the brain:
50%
saw their brain tumors shrink*
(4 out of 8 adults)
Among the 87 adults with RET+ mNSCLC who had cancer treatment in the past and received GAVRETO during the clinical study, 8 adults had tumors that spread to the brain before the study. No one received radiation therapy to the brain within 2 months before participating in the clinical study.
And of those adults who had tumor shrinkage, 75% (3 out of 4 adults) saw their response to treatment last for up to 6 months or longer.†
Please note that these results were only observed in a limited number of patients.
*It is important to know that a complete response (which means all tumors have responded and completely disappeared) does not mean the cancer has been cured.
†While the effects of treatment have lasted at least 6 months, the study is still ongoing.
‡Treatments received by patients before GAVRETO included chemotherapy, immunotherapy, multikinase inhibitors, or other systemic therapies.
Everyone responds to treatment differently
It is helpful to know what side effects you might experience.
-
A type of cancer treatment that targets specific types of cancer cells.
-
The most common type of lung cancer, named after the way cancer cells look under a microscope.
-
A type of cancer that forms in the thyroid and is a less common type of thyroid cancer.
-
Thyroid cancer that has spread to nearby tissue or distant parts of the body.
-
A test performed by your healthcare provider to identify the gene(s) that may impact the way a tumor grows, spreads, or reacts to certain treatments.
-
RET stands for rearranged during transfection, and it’s a type of gene that everyone has within their cells. In specific types of cancer cells, the RET gene is abnormal.
-
The molecules inside cells that carry genetic information and pass it from one generation to the next.
-
May be in the form of fusions or mutations; these genes drive the uncontrolled growth of cells, leading to cancer.
-
RET positive (RET+) stands for rearranged during transfection positive, and the term RET+ is used to describe cancer caused by abnormal RET genes.
-
A molecule or gene measured in tissue, blood, or other bodily fluids that can help determine the type of disease you have, how aggressive it is, and the best treatment.
-
Biomarker testing that is performed by your doctor that includes testing for all of the biomarkers recommended by current guidelines.
-
Standard chemotherapy aims to stop the growth of cancer cells by blocking all rapidly dividing cells. Chemotherapy may be given by mouth, injection, or infusion, or put directly on the skin. This depends on the type and stage of cancer being treated.
-
A type of cancer treatment that helps your immune system fight cancer.
-
A type of lung cancer driven by abnormal RET genes that has spread to other parts of the body.
-
A butterfly-shaped organ that makes hormones to help regulate your heart rate, metabolism, blood pressure, and body temperature.
-
A substance produced by glands in the body that regulates the activities of different cells and organs.
-
A type of targeted therapy that targets multiple types of cancer cells.
-
A type of thyroid cancer driven by abnormal RET genes that has spread to nearby tissue or distant parts of the body.
-
A type of cancer that forms in the thyroid and is the most common type of thyroid cancer.
-
A treatment that shrinks or kills thyroid cells. It is used to treat certain types of thyroid cancer.
-
When cancer spreads to other parts of the body.
-
A piece of DNA that gives the cells in your body instructions to perform certain functions.
-
When a gene breaks off and reattaches to another gene.
-
Any change in a cell’s DNA sequence.
-
When cancer has spread to other parts of the body.
-
May be in the form of fusions or mutations; these genes drive the uncontrolled growth of cells that leads to cancer.
-
All tumors have responded to a treatment and completely disappeared. This does not mean the cancer has been cured.
-
Tumors have responded to a treatment and shrunk in size by at least 30%.