Dive Brief:
- An experimental therapy from Allogene helped eliminate signs of cancer better than standard treatment in a Phase 3 trial in first-line large B-cell lymphoma, results suggesting the biotechnology company may have found a role to use donor-derived cell therapy against the deadly blood cancer.
- After 45 days of treatment, seven of the 12 patients given Allogene’s therapy in the study were negative for “minimal residual disease,” meaning that diagnostic tests could no longer detect signs of cancer. By comparison, only 2 of 12 placebo recipients hit that mark, a roughly 42-percentage-point difference that clears an important bar published literature has suggested is crucial for delaying a relapse.
- The results come from an early “futility” analysis. Allogene is enrolling 220 people in the study and expects to report in 2027 results showing whether treatment staved off cancer’s return. Company shares climbed about 30% early Monday, but still trade well below levels Allogene reached in 2020.
Dive Insight:
Allogene spun out of Pfizer’s cell therapy work in 2018 with plans to prove that donor-derived, or “allogeneic” cell therapies could prove a more convenient alternative to their personalized CAR-T counterparts. But like many of its peers, Allogene suffered several setbacks along the way. It’s lost most of its market value since going public.
In 2024, though, Allogene came up with a new way to show allogeneic treatments might have an important role to play in lymphoma. Rather than position cema-cel in settings where CAR-T therapies like Breyanzi and Yescarta are available, it set its sights earlier, testing the treatment in people who are at risk of relapse after receiving a widely used drug regimen known as R-CHOP.
Monday’s study results are an important early step towards validating Allogene’s choice. The therapy significantly exceeded the 25- to 30-point difference, compared to placebo, on minimal residual disease that investors and analysts had been looking for. The treatment also wasn’t associated with severe occurrences of the kind of immune or neurological side effects often associated with personalized cell therapies.
Half of the patients in the cema-cel arm experienced neurological side effects such as headache and dizziness that were judged to be “low grade.” Two had mild infections, such as a urinary tract infection or COVID-19, according to Allogene.
“These interim data suggest that an off-the-shelf CAR-T may be able to intervene during that important window before clinical relapse to eliminate residual disease and make earlier intervention feasible in routine clinical practice,” Zachary Roberts, Allogene’s chief medical officer, said in a statement, calling the data “encouraging.”
Personalized, or autologous CAR-T treatments, are largely given at specialized centers. Allogene aims to show that its donor-derived treatment could be more accessible to those who receive care at community cancers. A third of study participants were infused at these centers, which “bodes well for broad adoption,” wrote William Blair analyst Sami Corwin in a client note.
Roger Song, an analyst at Jefferies, added in a separate note that cema-cel could become a $3 billion asset for Allogene “that is currently underappreciated.” Song has previously predicted that cema-cel could bring in peak global revenues of $1.1 billion per year.
