Transcript
Today, I want to highlight what I see as one of the most transformative signals from ASH 2025 for relapsed/refractory myeloma: the movement of BCMA CAR-T into earlier lines of therapy. A lot of us are familiar with using cilta-cel already in the second line for a certain subset of patients. But what we learned from the phase 2 iMMagine-1 registrational study, which includes anito-cel, is that there are very high response rates with this new BCMA CAR-T target. The results were very impressive. Despite the patients being heavily pre-treated—most of them had 3 or more prior lines—the overall response rates landed in the mid-90% range, and about two-thirds to three-quarters of the patients achieved a complete or stringent complete response. That’s remarkable depth in this population.
How it really stands out, though, is from a safety standpoint. There was really no signaling for neurotoxic events. And unfortunately, in our previous BCMA CAR-T products, we have some of that experience. So now we’re talking about being able to use a BCMA CAR-T in earlier lines of therapy with almost no neurotoxicity safety signals. We saw that cytokine release syndrome does occur, but overwhelmingly, it’s low grade, and it’s manageable with the familiar protocols we have from our other BCMA CAR-T products.
So why is the potential use of anito-cel practice changing? First, the results support a continued shift of safely using CAR-T in earlier lines. We definitely no longer think about CAR-T as a last rescue option, and I think the eventual use of anito-cel will allow us to broaden the population of patients with whom it should be used. And then second, there’s the safety profile because of this. So we can say confidently that delayed movement disorders or cranial nerve toxicities haven’t been seen, and that matters a lot to patients and families, especially when you’re talking about using this in earlier lines. And third, this changes what we as advanced practice providers (APPs) need to be prepared for. Being able to safely use a very effective CAR-T product in earlier lines means that we need to be aware of earlier referrals, earlier discussions about next lines of therapy and the potential of CAR-T, and continue to identify appropriate patients in this space. From a practical perspective, I think this means we need to continue to strengthen our workflows. There’s been a lot of work done in the pre-, post-, and return to community practice CAR-T space. We need to continue to work on these referral pathways, organize potential patients for it sooner, and then make sure we have systems in place for monitoring the effects of CAR-T, such as cytopenias, infections, what the revaccination schedule looks like, and then long-term survivorship after CAR-T.
The real-world lesson from all the BCMA CAR-Ts is that access doesn’t end with infusion, right? We like to say it’s a one-and-done treatment, but really, patients return home to their community practices or their referring providers and they still need supportive care, they need their counts monitored, and they need to be followed closely. As APPs, we are the ones largely managing these patients in the communities.
The bottom line here is that anito-cel reinforces that CAR-T is no longer a last resort. If the results from iMMagine-1 hold up with longer follow-up, CAR-T will continue to become a routine part of early myeloma therapy. As APPs, I think it’s our job to get ready for this shift, both operationally, clinically, and in the way we guide patients through shared decision-making.
