NHS Funds Breakthrough CAR-T Therapy Breyanzi for Lymphoma Treatment in Spain

Bristol Myers Squibb (BMS) has announced the authorization of funding by the National Health System (NHS) for the CAR-T therapy lisocabtagen maraleucel (liso-cel), marketed as Breyanzi, which will be available from April 1st for the treatment of diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL), the two most common subtypes of lymphoma.

The funding includes second-line indications for patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMLB), and grade 3B follicular lymphoma (FL3B) who have relapsed within 12 months of completing first-line treatment or who are refractory to it. It has also been approved for fourth-line or later treatment for adults with relapsed or refractory follicular lymphoma.

Breyanzi will be available from April 1st in Spain for the treatment of diffuse large B-cell lymphoma and follicular lymphoma, following authorization of funding by the National Health System

Breyanzi is seen as a response to unmet clinical needs

Dr. Alejandrio Martin, hematologist at the Hematology Service of the University Hospital Complex of Salamanca, has highlighted that the arrival of lyso-cel (Breyanzi) in Spain is a crucial advance for treating diffuse large B-cell lymphoma and follicular lymphoma, pathologies for which it is estimated that in 2026 more than 4,000 and 2,500 new cases will be diagnosed, respectively.

“Although we have made great progress in treatments in recent years, the initial treatment is still chemotherapy combined with bispecific antibodies, and in a significant proportion of patients, it will not be successful. This creates a significant clinical need, as the prognosis for these patients will worsen considerably,” Martín explained.

Dr. Anna Sureda, head of the Clinical Hematology Service at the Catalan Institute of Oncology, has emphasized that CAR-T therapies are a “very intelligent” strategy, as they allow for the elimination of tumor cells exclusively, minimizing toxicity for the patient.

The Breyanzi therapy involves extracting and genetically modifying the patient’s own T lymphocytes and then reinfusing them, activating a massive immune response that destroys the tumor cells. “We are dealing with a personalized therapy that not only destroys malignant cells but also preserves healthy tissue,” Dr. Sureda highlighted.

Efficacy and safety of the Breyanzi therapy

Liso-cel (maketed as Breyanzi) has shown promising results in clinical trials, as seen in the Transform study for diffuse large B-cell lymphoma, where the therapy demonstrated a significant improvement in event-free survival (EFS) compared to standard treatment. Long-term results (34 months) showed a median EFS of 29.5 months in patients treated with Liso-cel, compared to 2.4 months in the control arm. The complete remission rate was 75% , with durable remissions in 40% to 50% of patients.

In the case of follicular lymphoma, the Transcend FL trial demonstrated an overall response rate of 97.1% and a complete response rate of 94.2% in third-line patients. Furthermore, 70% of patients maintained complete remission at three years.

The toxicity profile for Breyanzi is favorable, with a low incidence of serious adverse effects such as cytokine release syndrome and neurobiological toxicities. This profile allows for outpatient treatment to be considered for certain patients, which could improve their quality of life by allowing them to receive treatment at home, provided they have adequate family support and live near a healthcare facility that offers this service.

During the press conference, both Dr. Alejandro Martín and Dr. Anna Sureda highlighted Spain’s important role in hematological research. They both emphasized that the major challenge is ensuring that these therapeutic innovations reach patients quickly and equitably.

The CAR-T lymphocyte therapy Breyanzi is supported by leading Spanish centers, such as Vall d’Hebron Hospital, Hospital Clínic de Barcelona, ​​Virgen del Rocío Hospital in Seville, Hospital de Salamanca, Gregorio Marañón Hospital and 12 de Octubre Hospital in Madrid, which have been fundamental in the clinical trials that led to the approval of this therapy in Spain.

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(Featured image by Marek Studzinski via Unsplash)

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First published in iSanidad. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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