Elahere approved in EU as treatment for ovarian cancer
AbbVie's mirvetuximab soravtansine therapy OK'd for hard-to-treat patients
AbbVie’s Elahere (mirvetuximab soravtansine) has been approved in the European Union to treat adults with advanced ovarian, fallopian tube, or primary peritoneal cancer whose tumors are resistant to platinum-based chemotherapy, and have progressed while on, or after, one to three lines of previous treatment regimens.
With this approval from the European Commission, Elahere can now be used for the treatment of tumors that express high amounts of a protein called folate receptor-alpha, or FR-alpha. Patients are selected for treatment based on a diagnostic test that is now CE-marked, AbbVie announced in a company press release.
According to AbbVie, “Elahere represents the first treatment to demonstrate an overall survival benefit in a Phase 3 trial in platinum-resistant ovarian cancer compared with chemotherapy.”
For Roopal Thakkar, MD, AbbVie’s chief scientific officer and executive vice president of research and development, Elahere “provides a much needed clinically meaningful option for patients who receive the heartbreaking news their ovarian cancer has returned, fearing what’s next in their treatment journey after they’ve developed platinum-resistance.”
Elahere was fully approved in the U.S. for the same indication earlier this year, with a decision by the U.S. Food and Drug Administration that came only a few months after the therapy had been granted accelerated approval. Conversion to that full approval had been supported by data from a confirmatory Phase 3 clinical study called MIRASOL (NCT04209855).
Treatment approved for patients with platinum-resistant ovarian cancer
Epithelial ovarian cancer — the most common type of ovarian cancer — fallopian tube cancer, and primary peritoneal cancer all form in the same type of tissue and can be treated in the same way. These cancers often are diagnosed at an advanced stage, when they are more difficult to treat.
According to Clara Mackay, CEO of the World Ovarian Cancer Coalition, a global advocacy organization, “in Europe, ovarian cancer is three times more deadly than breast cancer.”
“Ovarian cancer can be devastating, taking women away from precious moments with their family, disrupting careers and the many other important contributions that women make to society,” Mackay said.
Patients with late-stage ovarian cancer are usually treated with surgery and platinum-based chemotherapy. However, over time, many become resistant to this treatment. Further, options for platinum-resistant ovarian cancer have been limited, often causing side effects that reduce quality of life.
New therapies for treating ovarian cancer are overdue, says Toon Van Gorp, MD, PhD, a professor of gynecological oncology at the University of Leuven in Belgium.
“It’s been 10 years since a new treatment for platinum-resistant ovarian cancer was approved in the EU, and now oncologists have an effective, new, targeted treatment option for these patients,” Van Gorp said.
First developed by ImmunoGen before being acquired by AbbVie, Elahere is an antibody-drug conjugate for infusion into the bloodstream. It’s comprised of an antibody that targets the FR-alpha receptor on the surface of ovarian cancer cells and is chemically attached to DM4, a toxic molecule.
DM4 is attached to the antibody via a breakable linker. When the antibody binds to the FR-alpha receptor, Elahere is taken in by the tumor cells. The linker breaks open and DM4 is released inside the tumor cells, causing them to die by disrupting their microtubules — a network of long, hollow cylinders that give cells their shape and serve as tracks for the transport of molecules.
It’s been 10 years since a new treatment for platinum-resistant ovarian cancer was approved in the EU, and now oncologists have an effective, new, targeted treatment option for these patients.
As in the U.S., approval of Elahere in the EU drew on data from 453 adults with difficult-to-treat ovarian cancer who took part in the MIRASOL study. In it, treatment with Elahere reduced by 35% the risk of tumor progression or death compared with standard chemotherapy.
Patients treated with Elahere every three weeks via intravenous, or into-the-vein, infusion also survived longer than those who were on standard chemotherapy (median 16.5 vs. 12.8 months), a difference that translated into a 33% reduction in the risk of death.
This approval makes Elahere the first antibody-drug conjugate available in the European Union, as well as in Iceland, Liechtenstein, Norway, and Northern Ireland, that specifically targets FR-alpha in platinum-resistant ovarian cancer, according to the company.
According to Mackay, “having new innovative options allows us to work toward a world where everyone living with ovarian cancer has the best chance of survival and the best quality of life possible, no matter where they live.”
Roche’s Ventana FOLR1 test can be run at diagnosis or as soon as platinum-based chemotherapy stops working to test for the presence of FR-alpha, also known as FOLR1, and identify patients who may benefit from treatment with Elahere. The diagnostic test is also cleared by the FDA for use in the U.S.
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