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NICE Recommends First Personalised Immunotherapy

The National Institute for Health and Care Excellence (NICE) has recommended the first personalised immunotherapy treatment for routine use in the NHS, with hundreds of people with an aggressive form of lymphoma set to benefit.

Diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) are aggressive subtypes of non-Hodgkin lymphoma.

Around 5500 people are diagnosed with DLBCL each year in England. It is an aggressive disease that progresses quickly and is the most common type of high-grade non-Hodgkin lymphoma (NHL). It can develop at any age, but most people diagnosed with DLBCL are 65 or over.

The condition does not respond well to chemotherapy; outcomes for people with refractory or relapsed disease are poor, and survival is limited, explained NICE.

Life-Extending Treatment

There is currently no standard treatment for relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma after two or more systemic therapies. Best supportive care usually includes salvage chemotherapy, given after the cancer has not responded to other treatments.

Axicabtagene ciloleucel (Yescarta, Kite) is a chimeric antigen receptor T-cell (CAR-T) therapy, a personalised cancer immunotherapy where a patient’s own immune cells are collected and modified so that they attach to and kill cancer cells. It is administered as a one-off intravenous infusion.

A total of 318 people received the treatment through the Cancer Drugs Fund (CDF) between December 2018 and October 2021 in England. Data collected over 36 months showed the median overall survival of people having axicabtagene ciloleucel was 28.5 months, and 45% of people were alive after 3 years. It was estimated that the median overall survival on best supportive care, which is salvage chemotherapy, is around 6.4 months.

NHS England's director of specialised commissioning and interim commercial medicines director, John Stewart, said: "This advanced therapy has been commissioned through the Cancer Drugs Fund since 2018, allowing evidence to be collected that confirms its benefits for patients facing this aggressive form of lymphoma."

Delight With Pioneering Treatment Recommendation

NICE said that new evidence, including data from a clinical trial and from people having axicabtagene ciloleucel through the CDF, "suggested that people having axicabtagene ciloleucel live longer than people having chemotherapy and have longer before their condition gets worse".

After reviewing the evidence NICE's independent appraisal committee felt that axicabtagene ciloleucel met NICE's criteria to be considered a life-extending treatment at the end of life.

"Taking this into account, the cost-effectiveness estimates for axicabtagene ciloleucel are within what NICE considers an acceptable use of NHS resources," NICE said.

The final draft guidance recommended axicabtagene ciloleucel within its marketing authorisation for routine use in the NHS to treat relapsed or refractory DBLCL or PMBCL in adults after two or more systemic therapies. This was incumbent on the company providing axicabtagene ciloleucel according to the commercial arrangement, underlined NICE.

It is estimated that just over 450 people in England will be eligible to receive this new treatment.

Helen Knight, director of medicines evaluation, at NICE, said she was "delighted" that the pioneering treatment had been recommended. "The evidence from its use in the CDF and clinical trials shows it can offer an effective treatment, helping people live longer and with a better quality of life," she said.

Asked to comment by Medscape News UK, director of services at Lymphoma Action, Dallas Pounds, said the charity was "pleased to receive the news" that NICE had recommended the treatment.

"It offers an innovative and exciting option for people with two forms of high-grade aggressive lymphoma after other treatments have been unsuccessful, and that is great news for the lymphoma community," she said.