ASH: Gilead preps filing for anito-cel on iMMagine-1 data

Gilead Sciences' Kite unit has showcased three new CAR-T therapies at ASH, headed by multiple myeloma candidate anitocabtagene autoleucel (anito-cel) which is being prepared for a filing and potential launch in 2026.

The BCMA-targeted CAR-T could be a competitor to Johnson & Johnson and Legend Biotech's already approved Carvykti (ciltacabtagene autoleucel) and Bristol-Myers Squibb's Abecma (idecabtagene vicleucel) if approved for marketing.

At ASH, Kite presented the results of the iMMagine-1 trial of anito-cel, which met expectations of strong efficacy with an overall response rate (ORR) of 96%, with 74% of patients achieving a stringent complete response (sCR) or complete response (CR), and 95% of patients testing negative for minimal residual disease (MRD). The CAR-T was being tested in patients who had received at least three prior lines of therapy.

Close attention was paid to the safety data from the study, and in particular rates of neurotoxicities, which have been held up as one way for anito-cel to differentiate itself from its rivals, which are respectively approved as second- and third-line options for multiple myeloma.

At the moment, Carvykti is growing faster than Abecma on what is viewed as superior efficacy data, including a higher complete response rate, with quarterly sales currently running above $500 million.

iMMagine-1 showed a rate of neurotoxicity of 8%, and no cases of delayed neurotoxicities like Parkinsonism and neuropathies or immune effector cell-associated enterocolitis (IEC-EC), which are both recognised side effects with J&J and Legend's CAR-T and can happen weeks or months after treatment.

"These data are compelling and are an important advancement for patients living with multiple myeloma," said lead investigator Krina Patel of MD Anderson Cancer Center.

"We rely on therapies that deliver continued meaningful efficacy, a predictable safety profile, and reliable manufacturing," she added." Anito-cel demonstrates that it could become a significant new treatment option in our efforts to improve outcomes for patients."

Anito-cel uses technology developed by Kite's partner Arcellx that is designed to enable high CAR expression, with quick release from the BCMA target, to minimise toxicity. Kite's hope is that its profile will make it suitable for use in outpatient or even community settings.

Bicistronic CAR-Ts

ASH also gave Kite the opportunity to reveal new data on a pair of its so-called 'bicistronic' CAR-Ts, which are designed to target two antigens at the same time. That is a new area of CAR-T therapy that was also explored at ASH in the DURGA-1 study of AstraZeneca's multiple myeloma candidate AZD0120.

Kite reported the results of two CD19 and CD20-directed CAR-Ts – codenamed KITE-753 and KITE-363 – that also include co-stimulatory domains designed to boost their efficacy, reduce cancer cell escape from treatment, and prevent relapse. They can also be produced more quickly than conventional CAR-Ts.

The two studies, both in patients with relapsed/refractory large B-cell lymphoma (LBCL), showed high rates of complete response with KITE-753 (79%) and KITE-363 (70%-plus), with an encouraging safety profile and no dose-limiting toxicities.

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