FDA gives fast track edge to ovarian cancer combo therapy now in testing
Lunresertib plus zedoresertib aims to treat hard-to-manage cancers
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The U.S. Food and Drug Administration (FDA) has granted fast track status to a combination of lunresertib and zedoresertib — two therapies in development by Debiopharm — as a potential treatment for certain people with hard-to-manage ovarian cancer.
The FDA awards this designation to experimental therapies that have the potential to address unmet needs in the care of serious diseases, with the aim of speeding the development of important new medications. With this status, Debiopharm will get access to perks such as more frequent communication with the FDA during the drug development process.
“The FDA’s decision to grant Fast Track designation for this combination therapy validates our synthetic lethality approach to treating high-unmet-need cancers,” Esteban Rodrigo Imedio, MD, executive medical director of oncology at Debiopharm, said in a company press release detailing how the two treatments each work.
According to the developer, lunresertib is a first-in-class therapy.
The new designation specifically covers the use of lunresertib and zedoresertib in people with ovarian cancer that has failed to respond or has come back following first-line platinum-based chemotherapy, and whose tumors harbor certain genetic alterations, namely CCNE1 amplification or a deleterious mutation in either FBXW7 or PPP2R1A.
Early trial results show disease control for most patients
Debiopharm is now running a Phase 1 clinical trial dubbed MYTHIC (NCT04855656) that’s testing the combination of lunresertib and zedoresertib in people with various types of solid tumors.
Early results, announced this month, showed that most of the 54 evaluable participants experienced disease control, meaning that their cancers either stayed the same size or got smaller.
Among the subset of participants with platinum-resistant ovarian cancer carrying any of the noted mutations, 80% experienced tumor shrinkage following treatment with the lunresertib-zedoresertib combo. The Phase 1 study is still recruiting participants at sites across the U.S., Canada, and Europe, with one study center each in the U.K. and Denmark.
[FDA fast track designation] highlights the potential of combining lunresertib and zedoresertib to provide a meaningful new clinical option for patients with … ovarian cancer who have exhausted platinum-based therapies.
Ovarian cancer is a type of gynecological cancer marked by the uncontrolled growth of cells around the ovaries. Rapidly-dividing cancer cells are constantly making copies of their DNA, and as they rush through the process, they often make mistakes. DNA repair mechanisms can help to fix those mistakes, which could otherwise kill the cancer cell.
Lunresertib and zedoresertib are both designed to interfere with DNA repair mechanisms, leaving cancer cells vulnerable to this damage and ultimately killing them. Lunresertib, also known as Debio2513, specifically blocks the activity of the protein PKMYT1, while zedoresertib (also known as Debio 0123) targets the protein WEE1.
Imedio said that the FDA’s decision to grant fast track designation “highlights the potential of combining lunresertib and zedoresertib to provide a meaningful new clinical option for patients with biomarker-selected ovarian cancer who have exhausted platinum-based therapies.”
