In an early clinical trial in the U.S., most women with hard-to-treat ovarian cancer given a low dose of cell therapy candidate liraltagene autoleucel, known for short as lira-cel, lived longer than they were expected to, according to new data announced by developer Anixa Biosciences.
In fact, one woman’s survival extended more than two years following treatment, per the company.
“Although these patients were treated at doses we believe are below the optimal therapeutic range, we are encouraged by the number of individuals who have lived far longer than expected,” Amit Kumar, PhD, chairman and CEO of Anixa, said in a company press release.
The company also announced that, thus far in the small study, no dose-limiting toxicities have been reported — in other words, the data indicate that all doses tested can be given to people without unreasonable safety risks. That finding will allow Anixa to test the therapy at higher doses.
According to the developer, this positive safety profile may in part be due to the way lira-cel is being administered. The therapy is given via intraperitoneal delivery, or directly into the abdominal cavity, rather than being infused into the bloodstream, which may help limit systemic toxicities, per Anixa.
The Phase 1 clinical trial (NCT05316129), sponsored by the Moffitt Cancer Center in Florida, was originally designed to test doses of lira-cel ranging from 100,000 to 10 million cells per kilogram of body weight. But with the positive safety data thus far, the trial has now been given a green light to expand, and test higher doses up to 1 billion cells/kg.
“The absence of dose-limiting toxicities observed thus far has given us the flexibility to safely explore higher dose levels than originally planned,” said Robert Wenham, MD, principal investigator of the trial at Moffitt. “With regulatory approval now in place, the program is positioned to advance into higher-dose evaluation under the amended protocol. This amendment allows us to further evaluate both safety and potential therapeutic benefit as the study advances.”
Trial testing lira-cell still recruiting in Florida
The early study is open to adults whose ovarian cancer did not respond to standard therapy and has progressed after two or more prior treatments. Participants will first undergo a round of chemotherapy to eliminate their existing immune cells, a process known as lymphodepletion, and then will receive treatment with lira-cel. Eligible women are still being recruited at Moffitt in Tampa.
Lira-cel is an autologous CAR T-cell therapy, a type of cell therapy in which T-cells, a type of immune cell, are collected from the patients undergoing treatment. These cells are then engineered in a lab to equip them with a chimeric antigen receptor or CAR, which essentially is a human-made molecular weapon that directs the cells to attack a specific target. With lira-cel, T-cells are specifically equipped with a CAR that targets follicle-stimulating hormone receptor (FSHR), a molecule expressed by cells in and around the ovaries.
According to Anixa, 12 patients have so far received low doses of lira-cel in the ongoing Phase 1 study. Based on these patients’ cancer stage at the time of entering the trial, the median expected survival time was only about three or four months. Four of the patients died at or before the expected time, and one was treated recently and is still alive.
2 trial participants still alive after 1 year
For the other seven, survival times were significantly longer than expected. One woman survived more than two years following treatment, and another three — two of whom are still alive — survived longer than a year. There were also two patients who died at 11 or eight months after treatment, and one who is still alive eight months after treatment, according to Anixa.
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