Hi, I'm Barry Paul from Atrium Health Levine Cancer Institute in Charlotte, North Carolina, and I'm going to talk about my abstract today, looking at idecabtagene vicleucel in patients with suboptimal responses to upfront transplant.

So this is defined by patients who went through induction chemotherapy and then went through an autologous stem cell transplant and had a response that was not up to a very good partial response or better. These would be patients who had a partial response or stable disease; patients who progressed after transplant were not eligible.

We assessed their response between 70 and 110 days after transplant. If they had unfortunately achieved a suboptimal response, they were eligible for enrollment. The patients who enrolled would get one dose of either idecabtagene vicleucel or Idel-cel, and then they were followed serially after that. It was investigator discretion whether or not to add maintenance therapy with lenalidomide.

So, eight patients out of the 32 patients who enrolled did get lenalidomide monotherapy as maintenance therapy. Of the 32 patients that enrolled, 31 patients were infused with Ide-cel. The follow-up that we have right now is 55 months. At 55 months, we do not have PFS data mature, but the 48 months PFS rate is 67%, which is very, very good in patients who did not achieve an optimal response to transplant.

Typically, patients who get a partial response to transplant would get about 18 months to 24 months of benefit. So the fact that we have more than doubled that already is very encouraging. The toxicities were manageable. The MRD negativity rate was quite good. Even the patients who did not get the lenalidomide maintenance are doing quite well. We have not had any overall survival signal yet. Everyone is still alive at this time.

So, they could get it up to six months post-transplant? Again, they were screened between 70 and 110 days. So roughly three months. Then, at that time, if they were eligible and wanted to enroll, they could go through apheresis and get their CAR-Ts manufactured, and then they could be infused.

The infection signal hasn't been that bad. There’s been a substantial amount of grade one infections. About 60% of patients have had grade one or grade two infections, but only 16% of patients have had grade three or grade four infections. These patients are prophylaxed at the institutional discretion. Almost all of these patients are getting IVIG and PJP prophylaxis, things like that, to prevent infections. But again, the grade three-four infection rate was only about 16%, which is quite good.

I actually don't know the answer to what the manufacturing failure rate was, but I will tell you that the expansion of the T-cells, which we did look at, was quite good. So, these patients who did get their T-cells infused had excellent T-cell expansion and seemed to have good T-cell activation, assuming that their response is continuing to mature.