Elahere approved in Canada for hard-to-treat ovarian cancer
Therapy shown to improve survival for gynecological cancer patients
The gynecological cancer therapy Elahere (mirvetuximab soravtansine) is now approved in Canada for adults with platinum-based, chemotherapy-resistant, ovarian, fallopian tube, or primary peritoneal cancer who have already received 1-3 treatment regimens.
With this approval by Health Canada, Elahere can now be used to treat patients with tumors that produce high amounts of a protein called folate receptor-alpha (FR-alpha).
Abbvie, which markets the therapy, said in a company press release that this decision establishes Elahere as “a potential new standard of care” for individuals with treatment-resistant FR-alpha-positive ovarian cancer.
“Elahere has been shown to extend the survival of patients and offers a much-needed new option for those facing this form of gynecological cancer, which has the lowest survival rate in Canada,” said Shannon Salvador, MD, an associate professor at McGill University in Montreal and the president of the Society of Gynecologic Oncologists of Canada.
“This approval marks a critical advancement in the treatment of advanced ovarian cancer,” Salvador said.
Epithelial ovarian cancer — the most common type of ovarian cancer — fallopian tube cancer, and primary peritoneal cancer all develop in the same tissue type and are treated in the same way.
Because their symptoms tend to be nonspecific, these gynecological cancers are often diagnosed at an advanced stage, making them more challenging to treat. While late-stage ovarian cancer is typically treated with platinum-based chemotherapy and surgery, many patients eventually become resistant to such treatment.
“Platinum-resistant ovarian cancer is a challenging disease with limited effective therapies and a poor prognosis,” said Salvador, also the director of the gynecologic oncology subspecialty residency program at McGill.
Elahere already approved in US, EU for treatment-resistant cancer
Elahere, approved in the U.S. and the European Union for this same indication, is composed of two parts: a toxic molecule called DM4 linked to an antibody that binds to the FR-alpha receptor on the surface of ovarian cancer cells. With antibody binding, Elahere is taken up by the tumor cells, and DM4 is released, killing the cell.
According to Rami Fayed, vice president and general manager of Abbvie Canada, “this new treatment is the first in over a decade for this type of ovarian cancer and marks a major milestone for patients.”
Health Canada’s approval of Elahere was supported by data from the now-completed Phase 3 MIRASOL (NCT04209855) clinical trial. A total of 453 adults with platinum-resistant FR-alpha-positive ovarian cancer were enrolled, and randomly assigned to standard chemotherapy or Elahere, given as an infusion into the bloodstream every three weeks.
The study’s main goal was progression-free survival — the time lived without cancer progression. Secondary measures were overall survival and the objective response rate, which is the proportion of patients with a predefined reduction in tumor size over a period of time.
The results showed that Elahere outperformed standard chemotherapy in reducing the risk of disease progression or death by 35%, according to Abbvie. The therapy also reduced the risk of death by 33%, which the company called “a statistically significant and clinically meaningful reduction.”
The approval of Elahere in Canada is not only welcome news for women in our community, but also a critically needed update to their care. … This decision gives them another treatment option and can help improve outcomes for those who are no longer responding to surgery and chemotherapy.
The objective response rate was also markedly higher in Elahere-treated patients (42% vs. 16%). Moreover, 1 in 20 patients (5%) achieved a complete response, or no signs of residual cancer. This compared with none given standard chemotherapy.
About one-quarter of the participants experienced a serious adverse reaction, most commonly pleural effusion, or fluid around the lungs (3%), abdominal pain (3%), intestinal obstruction (2%), ascites, or fluid in the abdomen (2%), and small intestinal obstruction (2%).
The therapy’s approval was welcomed by advocacy organizations in Canada.
“The approval of Elahere in Canada is not only welcome news for women in our community, but also a critically needed update to their care,” said Tania Vrionis, CEO of Ovarian Cancer Canada. “This decision gives them another treatment option and can help improve outcomes for those who are no longer responding to surgery and chemotherapy.”
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