Allogene posts encouraging trial cut

Allogene Therapeutics said its lead lymphoma study cleared an early hurdle, and its stock surged after the company posted interim data on April 13. (biospace.com) The company said 7 of 12 patients given cemacabtagene ansegedleucel, or cema-cel, became minimal residual disease negative by Day 45, versus 2 of 12 patients assigned to observation. That was a 41.6 percentage-point gap in the planned interim futility analysis of the Phase 2 ALPHA3 trial in first-line consolidation large B-cell lymphoma. (biospace.com) Allogene also said circulating tumor DNA in blood fell a median 97.7% from baseline in the cema-cel arm and rose a median 26.6% in the observation arm at the first Day 45 assessment. The company reported no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease, treatment-related serious adverse events, or treatment-related hospitalizations in this readout. (biospace.com) Minimal residual disease is the small number of cancer cells that can remain after standard treatment, like embers left after a fire. ALPHA3 uses a blood-based circulating tumor DNA test to find those embers after six cycles of first-line chemoimmunotherapy and then randomizes patients to either watch-and-wait care or a one-time cema-cel infusion. (allogene.com) Large B-cell lymphoma is often treated first with R-CHOP or similar chemoimmunotherapy, but Allogene says about 1 in 3 patients relapse after first-line treatment. The company designed ALPHA3 as a 240-patient study to test whether treating high-risk patients before an obvious relapse can prevent recurrence. (allogene.com; sec.gov) The treatment itself is an allogeneic chimeric antigen receptor T-cell therapy, meaning the cells come from healthy donors rather than being made from each patient’s own immune cells. Allogene says that off-the-shelf approach is meant to avoid the manufacturing delays that come with autologous, patient-specific cell therapy. (allogene.com; fiercebiotech.com) ALPHA3 is also testing whether that model can move cell therapy beyond major academic hospitals. Allogene said more than 60 trial sites are active, including centers outside the United States, and about one-third of screening activity and cema-cel infusions in this interim dataset came from community cancer centers, including sites new to chimeric antigen receptor T-cell therapy. (sec.gov; biospace.com) Investors treated the update as a major test for Allogene’s platform. Nasdaq halted the shares for news pending before the open, and the stock later traded at $3.56, up 31.1% by 12:03 p.m. Eastern, after touching $4.46 earlier in the session; BioSpace reported a gain of more than 50% in premarket trading. (marketbeat.com; biospace.com) The next question is whether clearing residual disease translates into patients staying in remission longer. Allogene said enrollment is expected to finish by the end of 2027, with an interim event-free survival analysis planned for mid-2027 and the primary event-free survival analysis in mid-2028. (biospace.com) For now, the April 13 readout gives Allogene a cleaner answer to the question it set up in ALPHA3: whether an off-the-shelf cell therapy can be used as a seventh cycle after first-line treatment instead of waiting for lymphoma to return. (sec.gov; allogene.com)