Allogene pins CAR-T hope on first-line use, autoimmune expansion
2024-01-05
免疫疗法细胞疗法临床研究临床1期
Allogene is pulling back on studies of its allogeneic CAR-T cell product in later-line settings for non-Hodgkin lymphoma and instead placing its bets on a new trial as a first-line consolidation treatment. The company is also joining the rush to move CAR-T therapies into autoimmune disease with a planned study in lupus.
The strategy - unveiled Thursday - will see Allogene deprioritise the mid-stage ALPHA2 and EXPAND trials of cemacabtagene ansegedleucel (cema-cel; previously ALLO-501A) in third-line large B-cell lymphoma (LBCL), citing its potential in the first-line setting to render later-line treatment obsolete. Meanwhile, the new study, dubbed ALPHA3, will investigate cema-cel in around 230 patients who have minimal residual disease (MRD) at the end of first-line therapy.
Allogene noted that although first-line treatment with chemotherapy is curative for many patients with LBCL, around a third who initially respond will relapse. The drugmaker suggested that in ALPHA3, the CD19-directed therapy will be given as a one-time, off-the-shelf treatment immediately upon discovery of MRD following six cycles of chemotherapy, taking advantage of data indicating that administration of CAR-T therapies to patients with low disease burden improves both safety and efficacy outcomes.
Allogene suggested that if positive, the ALPHA3 trial will allow it to “leapfrog” other personalised CAR-T therapies in development. “Until now, CAR-T development has been defined by how autologous CAR-Ts are made and used,” remarked Allogene CEO David Chang, adding that its allogeneic CAR-T platform “allows us to do what no autologous CAR T has done before.”
JMP Securities analysts that while ALPHA3 represents a new opportunity for cema-cel, the primary endpoint of event-free survival could take years to enrol and evaluate, giving the study an “uncertain timeline.” The analysts expect recruitment to begin in the second half of 2024.
The company has also kicked off a new arm of the ALPHA2 study to explore the use of cema-cel in patients with chronic lymphocytic leukaemia; enrolment is expected to start this quarter. Allogene suggested that its off-the-shelf approach in this disease may overcome limitations with personalised approaches, where T-cell dysfunction and high circulating tumour burden make the isolation of functional T-cells for autologous CAR-T manufacturing difficult.
Allogene also plans to start a Phase I study of ALLO-329 in lupus in early 2025. The company hopes that the design of the CD19-targeted CAR-T therapy will allow for “reduced or chemotherapy-free conditioning,” something that is seen as key to success in the autoimmune market where the risk tolerance of patients is very different to those with cancer.
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