Hi everyone. My name is Rahul Banerjee. I'm an assistant professor of medicine at the Fred Hutchinson Cancer Center in Seattle. I'm here at the 2024 Ash meeting in sunny San Diego, and I'll be presenting a poster later this week about, driving restrictions after Car-T therapy. So, in brief, many of you are familiar with Car-T therapy, and it's been a paradigm changing, technology for many of our patients with many blood cancer, not just myeloma, but also lymphoma, B-cell ALL, and so forth.

In the early days of Car-T, there was a lot we didn't know about Car-T therapy. And so the FDA set a restriction that patients following Car-T therapy should not drive for eight weeks or operate heavy machinery for eight weeks following Car-T therapy which is separate from the four week requirement for CRS monitoring. Cytokine release syndrome monitoring, where patients are asked to stay close to the Car-T center.

It's eight weeks thereafter, and it might have made sense in 2016, but it's now been perpetuated in every single package insert, including both of the myeloma Car-T products, Ide-cell, which is ABECMA and cilta-cel, which is CARVYKTI. If you look by the book the package insert the FDA guidance says you should not drive or operate heavy machinery for eight weeks following Car-T therapy.

We wanted to look at that because, you know, in real life, I my patients, they're confused, right? Because after four weeks I tell them, alright, four weeks, you know, Car-T has passed, you're free to go home, but you can't drive for four more weeks. And one it just seems weird. And two, again, it can create disparities, right? Patients, I know this many of them have had to move mountains to get family caregivers, loved ones to be around to support them in the Car-T period. And now they're done, but they're not really done because for another month they're after they can't drive. And that's how they work. That's how they get grocery. It's how they do so much.

So we did a two part study through the US Multiple Myeloma Immunotherapy Consortium, which is a group of at least 14, maybe 15, now centers around the US that we pooled our data to for the benefit of our patients. And we did two things. One, we actually looked at our outcomes and saw between weeks 5 to 8. So after the first four weeks for that second four week period, what does happen to the patients that might put them at risk of driving versus not?

And we did an expert survey of all car t prescribing physicians within the consortium to get a sense of what we think. Again, the caveat I'll add is by the book, you know, I'm not telling anyone to do what's not in the FDA package or it's kind of off label, but I think it's important that we actually look at this because this is what gets the FDA, hopefully to change how they're approaching things and brief out of over 600 patients we analyzed across all the centers.

Only five of them had some sort of event that possibly could put them at risk of impaired driving between weeks five through eight, for example, infections, you know, confusion or neurotoxicity or so forth, I would argue. And then most of those cases, for example, even if someone had an infection between week 5 to 8 after my after Car-T therapy, that doesn't immediately mean they can’t start driving immediately.

It means that to see their doctor and talk about things, I would argue, and many of you would agree, that, you know, you know yourself, right? And so if you're not able to drive, something's wrong. You feel off. You're not going to be driving thereafter. But again, less than 1% of these patients out of over 600 patients analyzed had some sort of impairment at that time period.

Unsurprisingly, our physicians agreed. We interviewed our physicians, and the vast majority of them agreed with driving restrictions between weeks one through four after Car-T therapy, our patients are at risk of cytokine release syndrome, which is fevers. They are at risk of neurotoxicity, which can lead to confusion. Many patients after Car-T therapy in the first four weeks are quite fatigued.

They're quite exhausted. And I get it. Weeks 5 to 8 not so much. And so in and of itself, what does this do? Not much because again, the FDA package insert is something we have to talk about with our patients every single time. However, we as a myeloma field are going to take this to the FDA and say, look, evidence of change has changed.

Times have changed. Let's make this, you know, easy. Evidence-Based solution to help our patients quality of life as they rebuild their lives after Car-T therapy.