Elahere For Platinum Resistant Ovarian Cancer
- Elahere is a new option for treatment of platinum-resistant ovarian cancer, a type of cancer that has become resistant to traditional chemotherapies containing the chemical, platinum.
- In studies, the drug increased survival by 33% and slowed the progression of the disease by 35%.
- A free test know as immunohistochemistry test can determine if Elahere is likely to work by determining if the cancer cells have too much of the folate protein which drives platinum resistance.
- Elahere tends to be well tolerated by may cause side effects including serious eye problems.
As the first and only approved treatment for this type of hard-to-treat ovarian cancer, it has been shown to extend survival by 33% and slow the progression of the disease by 35% compared to standard chemotherapy treatment.
Read MoreThe benefits of Elahere
The US Food and Drug Administration gave Elahere full approval based on the final results of the phase 3 MIRASOL Study which compared Elahere with standard chemotherapy in patients with platinum-resistant ovarian cancer who had already undergone up to three different treatments.
The trial, involving 453 patients, primarily looks at how long patients live without their cancer worsening. It also examines overall survival and response to treatment.
Final results showed:
- It reduced the chances of death compared to chemotherapy by 33%. Patients taking Elahere lived for an average of 17 months compared to about 13 months for the patients on chemotherapy.
- It reduced the chance of the cancer progressing by 35%. Patients on Elahere went nearly 6 months without their cancer spreading compared to 4 months for the patients on chemotherapy.
- More than 40% of patients taking Elahere saw their tumors shrink — and for 5% they disappeared completely.
- Elahere was also better tolerated than chemotherapy. Very few patients in the study had to stop taking it because of side effects.
The bottom line is that Elahere provides an effective new option for patients with folate receptor alpha positive tumors. These patients previously had very limited options. Elahere has changed that.
How does Elahere work?
Elahere is a type of drug known as an antibody-drug conjugate (ADCs).
Elahere attaches itself to the FRα on the cancer cells so it can effectively block the protein and stop it from getting signals that tell them to grow and spread.
Consequently, these cancer cells lose their ability to multiply rapidly, slowing down their aggressive expansion.
By blocking FRα, Elahere also disrupts the cancer cells’ ability to absorb folate. This weakens the cancer cells and also helps slow their spread.
“It has been a big advance for patients with platinum resistant disease to have this medicine that maybe can help have more of a chance for them to respond to and also maybe help prolong their life more than or at least prolong the time to the next recurrence more than other drugs,” Dr. Crispens says.
Potential Side Effects:
Elahere tends to have fewer side effects than many other chemotherapy drugs but it is not entirely free of side effects. A big concern doctors look out for is how it can damage eyesight. Some common eye problems that occur during Elahere treatment include:
- Blurred vision
- Dry eyes
- Light sensitivity
- Eye pain
- Vision changes
- Uveitis (eye inflammation)
“What’s different is going to be the focus on the eye toxicities,” Dr. Crispens cautions. “So before starting treatment and every odd numbered cycle through cycle seven the patient needs to go to an ophthalmologist or an optometrist and have an eye exam to be sure they’re not developing that inflammation.”
If you experience any eye problems, your doctor might recommend artificial tears to keep the eyes most and topical steroids to reduce inflammation
In severe cases, your doctor might temporarily stop Elahere until your eyes clear up.
Once improvement occurs, they might resume treatment at the same or a lower dose.
If the eye problems become very serious, they might recommend discontinuing Elahere altogether.
Another potentially serious side effect is lung inflammation, also known as pneumonitis, which can be severe or even life-threatening. Let your doctor know if you have new or worsening symptoms like trouble breathing, shortness of breath, cough, or chest pain.
Elahere may also cause nerve problems. Numbness, tingling, or weakness in the hands and feet are caused by a condition called peripheral neuropathy.
Other side effects seen with Elahere include:
- Fatigue
- Elevated liver enzymes
- Nausea or abdominal pain
- Reduced red or white blood cell counts
- Diarrhea or constipation
- Lower blood albumin levels
- Reduced blood magnesium levels
Women who are pregnant or breastfeeding or plan to get pregnant should definitely discuss the risks of taking Elahere.
Related: Women with Recurrent Ovarian Cancer Are Living Longer on PARP Inhibitors
How to know If you are a good candidate for Elahere
Dr. Crispens explains that a test can help determine if Elahere is likely to have benefit for a patient.
“So tumor testing for folate receptor alpha is basically done by doing some tests for the protein on the cell surface,” she says. “It’s a very specific test something called immunohistochemistry where they can basically take an antibody put it on the slide that has the cancer on it or a slice of the cancer on it and see what percentage the cells are folate receptor alpha positive and that’s how they determine eligibility for Elahere.”
Dr. Crispens goes on to say that eligibility for Elahere depends on having exceptionally high levels (exceeding 75%) of the FRα protein. If there is not very much of the protein, Elahere is less likely to work.
While research suggests that roughly 80% of both new and recurring ovarian cancers might have this protein, only around 35-40% of cancers resistant to platinum treatment exhibit such high levels.
Your doctor will consider Elahere if your ovarian cancer has returned after 1-3 prior platinum-based chemotherapy treatments that did not show benefit, indicating platinum resistance.
Your doctor can order an immunohistochemistry (IHC) test at no cost if:
- You have ovarian, fallopian tube, or peritoneal cancer
- You get your treatment in the US or a territory
- You haven’t had this test before
- Your doctor says it medically necessary
Two companies offer a free IHC test in Nashville and elsewhere in the US:
- FR-ASSIST program: Partnered with NeoGenomics and ImmunoGen, your oncologist can request a free test.
- Labcorp FR-ASSIST™ program: Offers a free FOLR1 IHC test for eligible patients.
This is not a standard test that most doctors order automatically.
“Folate receptor alpha testing probably can come into play at recurrence. It’s certainly not something you need in primary therapy,” Dr. Crispens says.
If your ovarian cancer does come back, it’s certainly worth having a conversation with your doctor to see if testing can help expand your treatment options.
Related: Changing Landscape Of Ovarian Cancer Treatment
When should I consider a clinical trial?
If your doctor finds that you are not a good candidate for Elahere or it stops working, your doctor may want you to consider joining a clinical trial, a type of study that follows patients on experimental drugs to see if they are safe and effective.
Many therapies go through clinical trial before being approved by the government for wider use.
“I would certainly very much encourage patients to consider clinical trials if they have access and they’re eligible because they may have access to drugs that they would not otherwise have access to,” Dr. Crispens says.
Two drugs are currently in clinical trials for platinum-resistant ovarian cancer:
- Farletuzumab uses a kind of protein known as an antibody to target FRα and stop the tumor from growing and spreading. Like Elahere, it is an ADC.
- STRO-002 is an investigational antibody-drug conjugate (ADC) that combines an antibody with a potent toxin to find the FRα-positive cancer cells and then poison them.
If a clinical trial makes sense for you, your doctor can help you identify and apply for the one nearest you.
Related: SurvivorNet Clinical Trial Finder
Questions for your doctor
- Is my cancer platinum resistant?
- Should I be tested to see how much FRα is present in my cancer cells?
- Am I a good candidate for Elahere?
- What are the potential side effects of Elahere, and how can they be managed?
- Will testing and treatment be covered by insurance or some type of financial assistance program?
- Should I consider a clinical trial?
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