Vaccine plus Keytruda bests standard care for hard-to-treat ovarian cancer
New trial data show combo using Tedopi slows disease progression
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The experimental cancer vaccine Tedopi (OSE2101), when given in combination with the approved injection therapy Keytruda (pembrolizumab), outperforms standard-of-care treatment in delaying disease progression in people with difficult-to-treat, chemotherapy-sensitive ovarian cancer.
That’s according to newly announced top-line data from a large European trial, shared by Ose Immunotherapeutics, the developer of the immunotherapy Tedopi. The data showed that the two-treatment combo worked better than available options at slowing cancer progression among trial participants.
“These results provide further clinical evidence supporting the potential of Tedopi in difficult-to-treat cancers such as ovarian cancer,” Marc Le Bozec, CEO of Ose, said in a company press release reporting the positive results from the Phase 2 TEDOVA clinical trial (NCT04713514).
Ovarian cancer is a form of gynecological cancer marked by the abnormal growth of cells around the ovaries. First-line treatment generally involves platinum-based chemotherapies, but this type of cancer usually becomes very aggressive.
Keytruda, which is already approved to help treat certain individuals with ovarian cancer, works by blocking molecular signals that cancer cells use to avoid the immune system, thus unleashing the body’s own defenses to more effectively attack the cancer. Keytruda is sold by Merck.
An investigational vaccine, Tedopi is designed to trigger the immune system to attack specific molecular markers expressed on some cancer cells. The therapy has previously shown positive results in a clinical study of people with advanced pancreatic cancer. Ose is also developing it as a potential treatment for certain forms of lung cancer.
Longer survival seen in patients given Tedopi-Keytruda combo
TEDOVA tested the experimental therapy in 185 people with platinum-sensitive ovarian cancer. The trial, sponsored by the nonprofit clinical research group Arcagy-Gineco, enrolled participants at 40 study centers across Europe.
All participants had either progressed following treatment with standard ovarian cancer therapies called PARP inhibitors and bevacizumab, or were not eligible for those standard treatments.
Participants in the Phase 2 study were divided into three groups. One group received standard-of-care treatments with available therapies. A second group received Tedopi as monotherapy (on its own), while a third group was treated with Tedopi in combination with Keytruda.
The study’s main goal was to determine whether Tedopi plus Keytruda would outperform standard of care in extending progression-free survival (PFS), the time patients remain alive without signs of their cancer worsening.
The results showed that the median PFS was significantly longer in the Tedopi plus Keytruda group than in the standard care group (4.1 vs 2.8 months). The risk of disease progression or death was also significantly lower, by 28%, with Tedopi plus Keytruda compared with Tedopi alone.
“The data highlight both the clinical activity of Tedopi as monotherapy and its strong synergy in combination with [Keytruda] in heavily pretreated patients,” Le Bozec said.
[This study] brings the [first] proof of concept for a vaccine strategy in [ovarian cancer], and actually the [first] positive trial in platinum sensitive [ovarian cancer] in years!
Side effects and other safety issues, including immune-related events, were more common when Tedopi was given in combination with Keytruda.
Alexandra Leary, MD, PhD, lead investigator of the TEDOVA study, noted that people with ovarian cancer “treated with platinum sensitive relapse post bevacizumab and PARP-inhibitors represent an unmet medical need with a progression free survival (PFS) of less than [three] months post platinum-based chemotherapy.”
“In this difficult to treat setting, the combination of [Tedopi] and [Keytruda] as maintenance [treatment] significantly improved PFS,” said Leary, an oncologist specializing in gynecological cancers who also serves as chair of the Gineco group.
Leary, who will be presenting detailed trial results at a conference later this week, said this study “brings the [first] proof of concept for a vaccine strategy in [ovarian cancer], and actually the [first] positive trial in platinum sensitive [ovarian cancer] in years!”
