Cilta-cel Shows Deep and Durable Responses for R/R Multiple Myeloma

Partners | <b>Tennessee Oncology</b>

Jesus G. Berdeja, MD, director of multiple myeloma research at Sarah Cannon Research Institute and hematology specialist at Tennessee Oncology, discusses the results of the CARTITUDE-1 trial for chimeric antigen receptor T-cell therapy with the newly-approved agent ciltacabtagene autoleucel for relapsed/refractory multiple myeloma.

Jesus G. Berdeja, MD, director of multiple myeloma research at Sarah Cannon Research Institute and hematology specialist at Tennessee Oncology, discusses the results of the CARTITUDE-1 trial (NCT03548207) for chimeric antigen receptor (CAR) T-cell therapy with the newly-approved agent ciltacabtagene autoleucel (cilta-cel; Carvykti) for relapsed/refractory multiple myeloma.

CARTITUDE-1 treated 97 patients with a median of 6 prior lines of therapy for multiple myeloma with 0.75 x 106 cells per kg, which Berdeja says is low compared with the dose of idecabtagene vicleucel (ide-cel; Abecma). At 18 months median follow-up, there was an overall response rate (ORR) of 98% and a stringent complete response (sCR) rate of 80.4%, with 94.8% of patients achieving a very good partial response or better. Berdeja says these results for a heavily pretreated population are comparable with those of frontline treatment for patients with multiple myeloma.

Progression-free survival (PFS) was not reached at 2 years, suggesting that the median PFS will be over 2 years, while Berdeja says patients like this population normally have a PFS of only a few months. Considering both the depth of response and duration of response, he says these results are very impressive.

Based on these results, cilta-cel was approved by the FDA in February 2022 for patients with relapsed/refractory multiple myeloma who had received 4 or more prior therapies including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

TRANSCRIPTION:

0:08 | CARTITUDE-1 is the study for cilta-cel in relapsed/refractory patients with [multiple] myeloma. These were heavily pretreated patients with a median lines of therapy of 6. These patients underwent treatment with a relatively low dose of CAR T [cells] compared to other products. I think it was point 0.75 x 106 per kg, which is roughly about 50 to 70 million CAR T cells compared to ide-cel, for example, which went up to 450 million CAR T cells. So, the results are spectacular and unprecedented.

Again, in this relapsed/refractory population, the expectation for new drugs is that if we see a response rate of 20% to 30%, that that's an active drug. That's often [why] drugs in the past have been approved in [multiple] myeloma.So, the overall response rate of 98% seen with cilta-cel is quite impressive. Those are the kind of responses that we see in the frontline population. And furthermore, it was the depth of response that was even more impressive, with almost 80% of patients having complete remission or better. Again, those are very impressive results.

1:30 | I think what's even more impressive thus far is that when we looked at the 2-year mark, the median PFS had not been reached, which tells us that the median PFS will be over 2 years. Again, something that we never see this late in patients with myeloma. These patients in general have a median PFS of just a few months. So, there’s lot more to come from this trial as it becomes more mature, but that's what's making this very impressive—not only the response rates, the depth of the response, but the durability of those responses.