How can real world data be used to guide treatment decision making?

How can real-world data be used to guide treatment decision making? Real-world data can be very helpful to guide treatment decision making in terms of four drugs that are already approved, how can we use them better? So several examples of this that I can think of for a patient with myeloma, many of you know the drug Bortezomabrabelcade, which can cause neuropathy. So that's a good example where real-world data shows that once per week dosing works just as well as twice per week dosing with fewer side effects. Another example from my research that I've done actually with SWAW, which is a big cooperative group, that was trial data, but we're looking at in the real-world setting as well, is that dexamethasone dosing. So patients who have lower dexamethasone dosing do just as fine. That would be a good example where is Bortezomababelcade a new drug in myeloma? Nope. Is dexamethasone a new drug in myeloma? No. So what real-world data is doing is saying, look, now that we know that these drugs exist and now that we know that there's heterogeneity in practice, because some doctors use twice weekly, some use once weekly, for dexamethasone some are on 40 milligrams weekly, some 20 milligrams weekly, we actually kind of embrace the heterogeneity in myeloma treatment to actually identify this is the best path. Based on all these different treatment paradigms that are out there, this one is associated with the best outcomes and the fewer side effects. And so that's an example of real-world data, real-world evidence that I would then take back to my patient in the next clinic room and say, well, we now know that dexamethasone 40 milligrams forever is not necessary. So let's lower your dexamethasone or let's make your Bortezomab lower or let's stop the Bortezomab. There is like that. Can real-world data be used to lead to cures? First part of the question is, you know, how do you define cure? It sounds really simple that a cure means the myeloma is gone. I would argue that it would mean the myeloma is gone, but you're also able to live your day-to-day life without thinking about the myeloma in terms of toxicities from the myeloma itself, side effects from the myeloma or side effects from the treatment that you've received for the myeloma. So I think one good example of where real-world data are very, very helpful is in terms of improving how we deliver care to minimize side effects. You're right that we're not going to retrospective real-world data looking back is not going to discover a cure for myeloma necessarily, but it'll mean that when we get to that cure with DNA-based phase one studies of new drugs, we're able to do it in a better way for more patients with fewer side effects. A good example of that would be the drug Bortezomab that many of you know as Velcade. So Velcade was FDA approved almost over 25 years ago, I think now. It has a lot of history for it. It is a proteasome inhibitor. It is a medication that works quite well against myeloma. It has been shown to improve outcomes in myeloma, not cure, but dramatically improve lengths of remission in several randomized trials. Its big side effect is neuropathy. So a good example of how real-world data, I think right here, right now, is changing how we care for our patients is historically Bortezomab, this drug Velcade, was dosed twice per week, Monday, Thursday, Monday, Thursday, or Tuesday, Friday, Tuesday, Friday. That's just how the trials were designed, you know, again, 25 years ago, over two decades ago, and it's kind of stuck that way in all the trials since then. So all these new trials looking at all these cutting edge new therapies, you know, for the little venetic clacks, which is a precision medicine drug in the Bellini study, the Bortezomab, that the new wonder drug was combined with, was still given twice per week, even though we found with real-world data that twice weekly Velcade, twice weekly Bortezomab has higher risk of neuropathy, a higher risk of tingling in the fingers and toes that can be quite painful, quite detrimental to the quality of life compared to once weekly Bortezomab. So myself and my colleague, Dr. Grubach Skor from UT Southwestern, have really been working on this using actually real-world data where in two forms, one, we actually surveyed physicians about how they do Bortezomab and what they see is happening, and physicians overwhelmingly prefer once per week Bortezomab. And then we actually used real-world data from a health source called Flatiron that looked at over 2,500 patients and looked at them. And there we found that once weekly Bortezomab, patients who received once weekly Bortezomab did equally as well as twice weekly Bortezomab and required fewer medications for neuropathy, fewer pain medications, fewer visits to neurology and so forth. And that would be a good example where real-world data is very meaningfully improving outcomes for our patients because we're taking those data to say, look, once weekly dosing does just as well for patients, fewer side effects, this should be the standard of care, not just for patients who might see in practice, but for future clinical trials as well. But we're taking this to the FDA. We're taking this to drug companies. We're saying, look, look at our data here. We understand that 20 years ago, the trials used to use twice per weekly Bortezomab. But with this real-world data, we know that once weekly Bortezomab is better for our patients, our loyalty as physicians is not to the trial protocol, and 20 years ago, it's to our patients. And so once weekly Bortezomab is the way to go. So I think that's along with an answer of saying that, do I expect real-world data to lead to the cure for myeloma? No, I don't want to overstate that. I think we absolutely need real prospective clinical trials, new substances, new investigational antibodies and bispecific therapies and CAR-T and so forth are all wonderful tools to have. But all those tools are given with our traditional therapies. And how do we optimize how our traditional therapies are given? Real-world data.