A Major Approval: ELAHERE gets OK for certain ovarian cancers
- Ovarian cancer is a serious disease which often has poor outcomes. Fortunately, more effective treatment options continue to be developed.
- The FDA recently approved a targeted therapy called ELAHERE for epithelial ovarian cancer that is folate receptor alpha positive and platinum-resistant.
- Epithelial refers to where the cancer develops (the surface layer of the ovary), while platinum-resistant means the cancer progressed after platinum-based chemotherapy, and folate receptor alpha positive means this type of receptor is present on cancer cells.
- ELAHERE is a combination of an antibody for folate receptor alpha (which is expressed in high amounts on a majority of ovarian cancer cells) and a microtubule inhibitor.
- The approval is the result of MIRASOL, a phase 3 clinical trial, which demonstrated improvements in overall survival, disease progression, and response to therapy when comparing ELAHERE to standard chemotherapy.
For patients with folate receptor alpha positive, platinum-resistant ovarian cancer, ELAHERE represents new hope after FDA approval, and gives patients the chance for longer survival compared with the previous standard treatment.
Read MoreWhat is ELAHERE?
ELAHERE is the brand name for the medication known as mirvetuximab soravtansine-gynx, developed by a company called ImmunoGen, Inc. It is a combination of medication (or conjugate) — including an antibody and a small molecular inhibitor known as an antibody drug conjugate.Antibodies are developed by your body to specifically target and bind foreign materials so the immune system can attack and remove that specific target only. Antibody drug conjugates use a similar mechanism where the antibody attacks the cancer cell only and delivers the pay load, or conjugate, directly to the tumor cell.
This is a highly specific mechanism which aims to reduce side effects to surrounding normal tissue. The antibody in Elahere (mirvetuximab) is targeted towards a receptor called folate receptor alpha (FRa) which is a protein present on a large portion of ovarian cancers. By using an antibody, the drug only targets cells that express the receptor the antibody recognizes. In this case it is the folate receptor alpha present on ovarian cancer cells. The antibody functions as a carrier for the other drug in Elahare, soravtansine, to be released directly at the cancer cell. This is called an anti-body drug conjugate and represents a targeted form of cancer therapy.
The small molecular inhibitor (soravtansine) is a medication that binds to a specific protein in the cell to stop it from functioning. ELAHERE targets microtubules, which are necessary for cell division, cell structure, movement, and a whole host of other critical functions.
Both of the drugs together work to kill cancer cells. The brilliance of this mechanism is it allows the drug to bind specifically to cancer cells or cells expressing the folate receptor alpha through the antibody component of the drug and delivers the small molecule directly to the tumor, which kills the cancer cell. This form of targeted therapy potentially saves patients from side effects over traditional approaches like chemotherapy, which can kill healthy cells in addition to the cancerous ones.
The use of antibody drug conjugates has become more common in recent years and is offering new hope for various types of cancers. Overall, these medications target the cells that express the receptor to the antibody and spare healthy tissue surrounding the cells that do not have that receptor. This represents another step forward in targeted therapy.
The Path to Approval
ELAHERE, just like any other medication that is prescribed or given to a patient, has a specific guideline for when it is used. These guidelines or rules are developed by the manufacturer of the drug — and the FDA can either approve or reject the use of the medication.
In order for a medication to get approved by the FDA rigorous testing needs to take place which can often last years. Initially, when a new drug is developed in the lab it undergoes testing to answer basic questions about the efficacy and safety of the drug. Once the drug is felt to be safe and effective it moves to the next phase of clinical research where the drug is used on people. During this time severe toxicity or side effects that occur are recorded and followed.
One of the last phases of clinical trial testing is called a phase 3 clinical trial, where the new drug is compared to the current standard of care to see if it is better than what we already have.
Who can get ELAHERE?
ELAHERE was approved for use in folate receptor alpha positive, platinum-resistant epithelial ovarian cancer.
Epithelial ovarian cancer is the most common type of ovarian cancer, accounting for about 90% of ovarian cancers. Epithelial, refers to the origin of the cancer, which is the surface layer of the ovary.
In ovarian cancer, a majority of patients (up to 90%), express folate receptor alpha, which is a receptor that binds folate, a molecule important for normal cell growth and function. Folate receptor alpha is present at a much higher rate on cancer cells than normal tissue, making it a good target for cancer treatment.
Platinum-resistant ovarian cancer refers to chemotherapy. Typically chemotherapy that uses platinum (cisplatin and carboplatin) is part of the treatment for ovarian cancers. If patients have undergone multiple rounds of chemotherapy and the disease progresses, then it is considered platinum-resistant.
To simplify, ELAHERE is for ovarian cancer patients that express a folate-receptor target and still have disease progression after prior treatment with chemotherapy.
What Did the Trial Show?
A phase 3 clinical trial called MIRASOL tested ELAHERE as compared to standard chemotherapy in 453 patients. The patients were platinum-resistant (having received prior chemotherapy), had epithelial ovarian cancer, and were folate receptor alpha positive on testing.
Approximately half of the patients received ELAHERE while the other half received chemotherapy. The medications were continued until the ovarian cancer progressed or there were too many side effects from the treatment.
When comparing the group treated with ELAHERE to those treated with chemotherapy, ELAHERE patients survived for 3.8 months longer (16.5 months vs. 12.7 months). Additionally, ELAHERE patients went longer without the disease progressing (5.6 months vs. 4 months), and the cancer had a better overall response to ELAHERE (42% vs. 16%).
Based on all of these results demonstrating ELAHERE to be superior to standard chemotherapy, it was approved by the FDA.
What are the Side Effects?
Like all cancer treatments, there is the potential for side effects with ELAHERE and it’s important to report any changes to your doctor.
Some common side effects include:
- Elevated lab values for AST and ALT (enzymes found in the liver)
- Fatigue
- Blurry vision
- Nausea
- Diarrhea
- Abdominal pain
- Numbness in the hands and feet
- Musculoskeletal pain
If you or a loved one has has ovarian cancer and think you might be a candidate for ELAHERE, the risks vs. benefits should be discussed thoroughly with your medical team.
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