Study backs safety of Gilead CAR-T as outpatient therapy

CAR-T therapies can achieve remarkable efficacy in the treatment of haematological cancers, but the risk of side effects means that the cell infusions are almost always administered to in-patients under close supervision in clinics.

Now, new real-world data from the use of Gilead Sciences/Kite Pharma’s Yescarta (axicabtagene ciloleucel) in outpatients suggests those restrictions may no longer be necessary, allowing them to be delivered outside of designated treatment centres.

That could improve access to the therapies and the use of hospital resources, overcoming bottlenecks that restrict their use, and may become more acute as CAR-Ts move into earlier lines of cancer therapy and into new applications like autoimmune diseases.

CAR-T treatment poses a risk of serious toxicities, including cytokine release syndrome (CRS), encephalopathy, and neurotoxicity, which in some cases can be life-threatening, although, these have become less problematic as clinical teams have become more experienced and adept at managing them.

The new analysis – reported at the ongoing 6th European CAR T-cell Meeting in Valencia, Spain – was based on a literature review of data from more than 300 patients treated with CAR T-cell therapy from 10 observational studies conducted at nine centres in the US that treated some of their patients on an outpatient basis.

There were variations in the way outpatient Yescarta treatments were handled, but generally involved close monitoring of patients for at least the first 14 days post-infusion, either in or close to treatment centres and sometimes with the aid of wearable devices or telemedicine.

The results showed post-infusion hospital admission rates for patients receiving CAR T-cell therapy in an outpatient setting were 50%-92% overall and 23%-85% within three days of infusion, with fever the most common reason for hospitalisation and the average length of stay seven to 14 days.

The data shows that a sizeable proportion of them could avoid admission altogether, and suggests that those who were admitted spent no longer in hospital than those cared for as in-patients.

CRS was seen in 57% to 92% of patients, with 2% to 5% severe cases of grade 3 or higher. Neurotoxicity, meanwhile, occurred in 29% to 54% of patients, with grade 3 or higher observed in 5% to 20%. Mortality was 0% to 29%, and most cases were due to disease progression.

“These findings provide important insights for treating physicians and healthcare authorities on the use of CAR T-cell therapy in the outpatient setting,” said Dominique Tonelli, head of medical affairs for Australia, Canada, and Europe (ACE) at Kite.

“This is important to support stretched healthcare systems around the world and helps ensure that patients in need of further treatment options get the care they need,” she added.

Yescarta was first approved in 2017 and is used to treat large B-cell lymphoma and follicular lymphoma, both forms of non-Hodgkin lymphoma (NHL).

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