We also presented at the American Society of Hematology an analysis done by the CIBMTR looking at the vein-to-vein time of patients treated with CAR T-cell therapy, axicabtagene ciloleucel CAR T-cell therapy, as a standard of care for large B-cell lymphoma. Our interest was to find out if patients had a longer time to their infusion of CAR T from when their cells were collected, their apheresis for manufacturing was done, the time to infusion, if those patients had better or worse outcomes.
Essentially what we found in a very large number of patients, over 1,000 patients, is that patients who had a longer vein-to-vein time were more likely to be older and are more likely to have comorbidities. For patients who had a vein-to-vein time of at least 40 days they had more prior treatments and they were more likely to have received bridging therapy. What we don’t know is if the bridging itself caused them to have a longer time to infusion or if their aggressive disease mandated that they get bridging so they had a longer infusion time or if the manufacturing process itself took a long time. We do know that the average time to manufacture for axi-cel is very short, around 18 days, so that’s unlikely to be the cause but we don’t have that data available.
Essentially what we found is that progression free survival at 24 months was lower for patients with a vein-to-vein time of 40 days or longer. So those patients had a worse outcome if it took longer to get them their CAR T-cells; whether they had aggressive disease mandating bridging or the manufacturing time was longer, we don’t fully understand. That worse outcome was similar for overall survival.
That said, for patients who did have a partial response or a complete response, regardless of their vein-to-vein time, they had similar outcomes. So for those who did get a response they did similarly well.
So more work to be done but we found in the real world that over 84% of patients with relapsed/refractory large B-cell lymphoma received axi-cel within five weeks after leukapheresis; those patients who were getting it more than 40 days from leukapheresis did have worse outcomes and more work has to be done to figure out why.
I thank you for your attention.