The Tandem 2023 meeting that is currently being held in Orlando, Florida was full of very, very important results that were presented in the late abstract session. I had the honor presenting on behalf of all the investigators the results of KarMMa-3, which was a randomized trial of a BCMA-directed CAR-T therapy called ide-cel against standard, conventional chemotherapy.
This was for patients who had had two to four lines of treatment...
The Tandem 2023 meeting that is currently being held in Orlando, Florida was full of very, very important results that were presented in the late abstract session. I had the honor presenting on behalf of all the investigators the results of KarMMa-3, which was a randomized trial of a BCMA-directed CAR-T therapy called ide-cel against standard, conventional chemotherapy.
This was for patients who had had two to four lines of treatment. I think it’s important for the listeners to recognize that the current approval for ide-cel is for patients beyond fourth line of treatment. The important thing was that these patients had to have been exposed to the three major classes of drug, IMiDs, proteasome inhibitors, and CD38 monoclonal antibodies.
The results in this randomized trial, which was a 2:1 randomization, showed a clearer superiority for ide-cel therapy in this patient group. One, complete remission rates was five times higher. Two, progression-free survival was significantly better for the ide-cel group, and it was 13 months versus four months. The data for survival is still not mature enough so that was not presented, but the important thing was that the safety profile of ide-cel in this situation is similar to the safety profile of ide-cel in patients more advanced.
What it tells us, and this is, “Why is this important?,” will your listeners or your readers ask, it’s important because now with quadruplet therapies and with monoclonal antibodies being approved earlier in the course of the disease, more and more patients are now being refractory and triple-exposed earlier in their disease journey. So what KarMMa-3 was able to do was to show that patients who were triple class refractory, triple-class exposed and were within two to four lines of prior therapy, would have a significant benefit. Moreover, the benefit was across all risk categories: high-risk cytogenetics, high [inaudible] stage three, and tumor burden. So we really think that this is a game changer, and because of that, it was recently published in The New England Journal of Medicine.