Gilead’s CAR T-cell therapy heralds a paradigm shift in B-cell lymphoma

Pharma News: Peter Mac is at the fore of two major clinical trials which assessed CAR T-cell therapy as a treatment for aggressive B-cell lymphoma.

These Phase III trials, presented at the recent global American Society of Haematology (ASH) conference, assessed different CAR T-cell therapies – Yescarta in the ZUMA-7 trial, Kymriah in the BELINDA trial – and each involved patients whose aggressive B-cell lymphomas were progressing within a year of receiving a first-line treatment.

Gilead’s Yescarta (axicabtagene ciloleucel) was found to offer “significant improvements, as compared with standard care” with 83% of the CAR T-treated patients responding to the therapy compared to 50% who received the standard second-line treatment. The event-free survival at two years was 41% and 16% respectively.

“Results from the ZUMA-7 trial herald a paradigm shift: axi-cel [Yescarta] should be a new standard for patients with second-line relapsed/refractory large B-cell lymphoma,” said Dr Frederick Locke, Moffitt Cancer Centre in Tampa, the lead study author of the trial.

Novartis’ Kymriah (tisagenlecleucel) was “not superior to the standard salvage therapy” though “additional studies are needed to assess which patients may obtain the most benefit from each approach”.

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Associate Professor Michael Dickinson, Lead of the Aggressive Lymphoma disease group within Clinical Haematology at Peter MacCallum Cancer Centre and Royal Melbourne Hospital, recruited patients into either trial was a co-author on both papers.

“These trials have given us important information about the potential benefits of CAR-T-cell therapy in aggressive B-cell lymphoma, and avenues for future research, in a patient group for which prognosis is poor and we need additional clinical options,” Associate Professor Dickinson said.

Peter Mac performed Australia’s first CAR T-cell clinical trial in 2007 and has since pioneered this therapy, and is Australia’s only onshore manufacturer of CAR-T products.