Gilead’s CAR-T therapy marks first breakthrough in 30 years

Pharma News: Gilead’s CAR-T therapy has emerged as a game-changer for patients battling early relapsed or refractory large B-cell lymphoma (LBCL), a form of blood cancer. The results of the Phase 3 ZUMA-7 study have unveiled a significant increase in overall survival (OS) when compared to the current standard treatment involving high-dose chemotherapy plus autologous stem cell transplant (HDT/ASCT).

Yescarta (axicabtagene ciloleucel [axi-cel]) has become the first treatment in nearly three decades to demonstrate a noteworthy improvement in survival rates for this particular patient population. These findings were unveiled at the prestigious 2023 International Conference on Malignant Lymphoma (ICML) meeting last week.

The ZUMA-7 trial analysed patients with relapsed or refractory LBCL, focusing on the potential of Gilead’s Yescarta as a curative treatment in comparison to the standard regimen. With a median follow-up of four years (47.2 months), the study found that a single treatment with Yescarta resulted in increased overall survival (p-value = 0.0168) compared to the traditional standard of care. The risk of death was reduced by 27.4%, equating to a remarkable 38% relative improvement in overall survival (OS) for patients with LBCL who had experienced early relapse or refractory disease within a year of completing their initial therapy.

Professor Michael Dickinson who is the Lead of Aggressive Lymphoma stream, Haematologist at the Peter MacCallum Cancer Centre and co-author of the ZUMA-7 trial, expressed his enthusiasm regarding these findings. He highlighted the rarity of demonstrating overall survival advantages with newer health technologies, particularly in the field of diffuse large B-cell lymphoma treatment.

“It puts to bed the question about how active these CAR-T treatments are and how promising they are when put up against chemotherapy,” Professor Dickinson emphasised.

In Australia, the funding of CAR T-cell therapies is provided jointly by the Government and the States and Territories, in line with arrangements agreed to in the 2020 – 2025 Addendum to the National Health Reform Agreement. Yescarta became the second CAR-T therapy to receive funding in Australia after its announcement in August 2021.

The current standard of care for this patient population typically involves a multi-step process culminating in a stem cell transplant. It starts with chemoimmunotherapy, followed by high-dose chemotherapy and, if the patient is able to tolerate further treatment, ultimately leads to a stem cell transplant. The ZUMA-7 study revealed that while less than 40% of patients managed to complete their stem cell transplant under the traditional approach, an impressive 94% of patients in the Yescarta group successfully underwent the procedure.

The ground-breaking results from the ZUMA-7 study represent a significant leap forward in the treatment of early relapsed or refractory LBCL. This remarkable achievement marks a pivotal milestone in the development and utilisation of T cell redirecting treatments, solidifying their position in lymphoma treatment.

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