Survival data from a follicle-stimulating hormone receptor-targeted CAR-T therapy in recurrent ovarian cancer are adding to a limited evidence base for cell therapy in a disease where options after second-line treatment remain scarce.
Anixa Biosciences (Nasdaq: ANIX), based in San Jose, California, reported updated survival observations from its ongoing Phase I trial of liraltagene autoleucel (lira-cel), an autologous CAR-T therapy targeting the follicle-stimulating hormone receptor (FSHR), in patients with recurrent ovarian cancer. The data, presented May 7, 2026, at the International Society for Cell & G ene Therapy annual meeting, showed that multiple patients have survived beyond the expected median of three to four months based on disease stage and prior treatment history, the company said.
Among patients treated to date, one survived 28 months following treatment, three survived greater than one year at 18, 17, and 17 months respectively, and four additional patients survived 11, 11, 8, and 7 months respectively. Three of the patients who reached 18, 17, and 11 months remain alive, and one additional more recently treated patient is also currently alive, according to the company. On the safety side, no dose-limiting toxicities have been observed across the first three dose cohorts, and there have been no instances of immune effector cell-associated neurotoxicity syndrome or significant cytokine release syndrome. All doses have been administered by the intraperitoneal route, and all significant adverse events reported to date were characterized as unrelated to lira-cel.
The Phase I trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety and tolerability, determine the maximum tolerated dose, and assess preliminary evidence of clinical activity. The data presented reflect an interim readout from an ongoing dose-escalation study; no formal efficacy analysis has been reported, and the patient numbers across individual cohorts were not disclosed. The trial is being conducted in collaboration with Moffitt Cancer Center. The next planned cohort is expected to evaluate a dose approximately three times higher than the previous cohort and will incorporate lymphodepletion with cyclophosphamide and fludarabine, which the company said may support CAR-T cell expansion and persistence.