New Breyanzi approval comes at a timely moment for Allogene

Allogene’s confirmation last week that it had started enrolling patients into a study testing cemacabtagene ansegedleucel in chronic lymphoblastic leukaemia came just a day before US approval in this setting of Bristol Myers Squibb’s rival anti-CD19 Car-T therapy Breyanzi. Though cema-cel is allogeneic while Breyanzi is autologous the coincidence is a happy one: it could refocus attention on CLL as a Car-T target, many years after being initially studied, only to be deprioritised in favour of acute leukaemias and non-Hodgkin’s lymphoma. The cema-cel trial in question is Alpha-2, which initially focused on third-line DLBCL, but which now includes a planned cohort of 12 CLL patients relapsed/refractory after at least two therapy lines including a BTK and a BCL-2 inhibitor. The baseline set by Breyanzi’s updated label is a 20% rate of complete responses, but notably the number is worse if all leukapharesed patients are included. It’s here that an allogeneic product could have an edge: not only do CLL patients tend to have poor-quality T cells, undermining the potential of an autologous therapy, an off-the-shelf product could avoid long waits between apheresis and treatment, when patients risk progressing. Allogene promises initial data by the end of the year.

Summary of registrational Transcend CLL 004 study (NCT03331198) result

Source: updated Breyanzi US prescribing information.