New Option For Ovarian Cancer Recurrence
- Elahare is an antibody drug conjugate. This kind of new anti-cancer drugs, known as “biological missiles,” is leading a new era of targeted cancer therapy.
- As of today, Elahare is the first and only FRα-targeted treatment for platinum-resistant ovarian cancer.
- To be eligible to receive Elahere, the tumor must test positive for folate receptor-alpha AND the patient must have not responded to or are no longer responding to treatment with platinum-based chemotherapy AND have received 1 to 3 prior types of chemotherapy.
- Elahare is an given by infusion (IV or a port) every 3 weeks. Each infusion typically takes anything from 1 to 3 hours.
However, a new drug called Elahere (generic name mirvetuximab soravtansine) may offer hope to patients with such resistant cancers.
Read MoreFolate Receptor Ovarian Cancer
Ovarian cancer cells commonly carry folate receptor alpha (FRα) protein on their surface. Up to 80% of new and recurrent ovarian cancers may carry this protein. Generally, FRα levels tend to be high in more aggressive ovarian cancers.
What is Folate Receptor?
Folate receptors are like “doors” on the surface of cells. They let in a vitamin called folate (also known as vitamin B9) which is crucial for the growth and division of cells, both healthy and cancerous ones. In ovarian cancer with folate receptors, there are more of these receptors on cancer cells than on normal cells.
This is important because it allows doctors to use special treatments that specifically target and fight the cancer cells, while leaving the healthy cells unharmed. It’s like attacking the bad guys without hurting the good guys. This targeted therapy can be really helpful in treating ovarian cancer effectively.
How Does Elahare Kill Cancer Cells?
Elahare is an antibody-drug conjugate. This kind of new anti-cancer drugs, known as a “biological missile,” is leading a new era of targeted cancer therapy.
Dr. Lyons explains: “what that means is that the antibody part of the drug conjugate binds to the folate receptor on the tumor cells, and then that gets taken up into the tumor cell. And then the drug that it is conjugated with is the part that actually kills the tumor cells, by affecting the tumor cells ability to divide.”
To summarize:
- Elahare attaches to the outside of the cancer cell
- After binding to FRα, Elahare is taken into the cell
- Elahare releases a strong cancer-killing drug inside the cancer cell
- The cancer-killing drug can also impact other nearby cells that may be cancerous
Dr. Lyons also explains that Elahare is given as an IV infusion, every three weeks, typically in the hospital or in the outpatient chemotherapy infusion center (similar to the place where you received your upfront chemotherapy). She also adds that it shouldn’t be painful and it would typically last anywhere from one to three hours.
Who Can Receive Elahere?
Before you start treatment, your doctor will test your tissue sample to confirm that your cancer over- expresses FRα. To do this, your doctor can use tumor tissue stored from an earlier biopsy or surgery or take a new sample.
To be eligible to receive Elahere, a woman would have to be on platinum therapy that has failed or for whom it did not work. So, to be eligible, patients must:
- test positive for folate receptor-alpha (FRα) AND
- have not responded to or are no longer responding to treatment with platinum-based chemotherapy AND
- have received 1 to 3 prior types of chemotherapy.
“Although we have Elahere now, which is a fantastic opportunity for patients with platinum resistant ovarian cancer. It’s really important to remember that only about 30 – 35% of people will actually be positive for the folate receptor alpha. If you’re not positive, then you’re not a candidate for Elahere. But there are other chemotherapy options available specifically, single chemotherapy plus bevacizumab,“ adds Dr Lyons.
“Practice-changing” Results
“Now we’ve shown that Elahere is better than the available therapies. We have longer progression-free survival, which means the patients are living longer without their cancer progressing. And most importantly, we have demonstrated that patients are living longer,” Anna Berkenblit, Chief Medical Officer at biotech company Immunogen, which sponsored the MIRASOL trial, told SurvivorNet. “This is unprecedented and it is practice changing.”
The findings indicate that patients with ovarian cancer should speak to their doctors about testing for the FRα protein and see if they are eligible for this ground-breaking new treatment.
Dr. Ursula A. Matulonis, chief of the Division of Gynecologic Oncology at Dana-Farber and Co-Principal Investigator of the SORAYA study, expressed excitement at Elahere’s potential after the accelerated approval.
“This accelerated approval of mirvetuximab soravtansine for recurrent, platinum resistant, folate receptor alpha positive recurrent ovarian cancer is incredibly meaningful for patients who have this cancer,” she said. “There have been no approved therapies for platinum resistant ovarian cancer since 2014, so today’s action by the FDA is a very significant milestone.”
FDA granted accelerated approval for Elahere, in November of 2022, for adult patients with folate receptor alpha positive, platinum-resistant ovarian cancer patients.
What’s the Data?
SORAYA evaluated the benefit and safety of Elahere in 106 patients with folate receptor alpha (FRα)-high, platinum-resistant ovarian cancer who have received one to three prior systemic therapies. It was a phase III study, meaning that it offers the highest level of evidence in medicine.
However, it must be noted that this drug was not compared to any other drug in the trial. Rather, the ability of this drug to cause a clinically meaningful response, termed objective response rate (ORR), in the patients was thoroughly evaluated using standardized criteria.
The duration of this response (DOR) and progression-free survival (PFS) were also evaluated. PFS is the length of time a patient can live without a worsening of their disease.
The results of the SORAYA trial were promising enough that the drug was given emergency approval by the FDA and the MIRASOL trial added to that, making a full FDA approval likely.
The MIRASOL trial, meant to further evaluate the safety and efficacy of the drug, looked at how it performed compared to giving chemotherapy alone in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer.
In the trial, more than one-third of patients (36%) receiving Elahere (who had previously been treated with a drug called bevacizumab) experienced improved progression-free survival and more than one-fourth (26%) experienced improved overall survival.
In another, smaller group of patients who had not previously been treated with bevacizumab, progressional free survival was 34% better and overall survival was 49% better than when patients received standard chemotherapy.
There is also some hope that the new drug can be used when ovarian cancer is diagnosed in earlier stages.
“It is also worth noting that ongoing studies are evaluating moving the drug to being used in earlier stages of the disease,” said Dr. Kathleen Moore, Associate Director of Clinical Research at the Stephenson Cancer Center at the University of Oklahoma, who presented the MIRASOL findings.
Questions to Ask Your Doctor
- Is my cancer platinum sensitive?
- Has my cancer been tested for the FRα protein?
- Can/should you order an immunohistochemistry (IHC) test?
- What additional tests might I need?
- Am I eligible for Elahere?
- What side effects should I be aware of?
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