We feel really fortunate this year to be able to present data from our IMAGINE-1 pivotal phase two trial for patients with relapsed/refractory multiple myeloma. Importantly, this is a study that has been enrolling these patients and we’ve finished completion of enrollment as well as dosing of the patients. The updated data that we’ll be presenting will be on 98 patients who have at least one month of follow-up and 86 patients who have at least two months of follow-up for safety and efficacy respectively. In that group of patients, the median follow-up time is nine and a half months, and we’re happy to report that 97% of the patients have already demonstrated a response by IMWG criteria as assessed by the investigators on the trial. Of those 62% of the patients are in complete response and we do expect the complete response rate to change over time.
What we’ve seen with CAR-T studies is that complete response rates tend to deepen as patients have more follow-up. So the appropriate comparator is to look at the number of patients incomplete response at that amount of follow-up time. When thinking about comparing it to other studies, for instance, with that complete response rate, we’ve looked at things like progression-free survival rates at six months and 12 months, and those are looking consistent with what we saw in our phase one trial. So those are all very encouraging things. Importantly though, that comes also with looking at the safety profile, and this is one of the things we think may be a differentiator for a needle cell compared with other products that are available presently. Importantly, when we’re thinking about the number of patients who have cytokine release syndrome, for instance, what we’ve seen is that over 80% of the patients have either grade one CRS or no CRS at all, which are quite manageable in academic medical centers, so that’s very encouraging.
We also look at Immune effector cell-associated neurotoxicity syndrome (ICANS) or neurotoxicity related to the expansion of those immune cells and only 9% of the patients have ICANS on this study and there’s only one grade three event in those. So taken together, those are really nice numbers, but it’s also important that this group of patients, none of them have experienced delayed neurotoxicity. Things like Parkinsonism, cranial nerve Palsies, Guillain-Barré, which have been reported with some other products that are targeting BCMA, and so we think that could be a major differentiator for this product compared to those that are on the market today. Finally, we are really excited because this is in partnership with Kite, and Kite has a long history of manufacturing CAR T-cells and turning them around in a pretty short interval to get back to patients very reliably, and we expect that when this product hits commercial, they will actually manufacture at about the same pace that we’ve seen with Yescarta and Tecartus, which is somewhere in the range of two to three weeks from what we’ve seen with those products. It’ll roll out first in Imagine three, which is a randomized phase three study that has already begun enrollment and that is randomized in second through fourth line patients against standard of care. So overall, we’re really excited by where the program is. We’re excited by the partnership and we’re looking forward to bringing this product to the market in 2026 for patients.
