Dr Mikkael Sekeres: ASH 2023 to Foster Discussion of Timely Themes, the Latest Data in Hematology

Mikkael A. Sekeres, MD, chief of the Division of Hematology at Sylvester Comprehensive Cancer Center, University of Miami, and chair of the American Society of Hematology (ASH) Committee on Communications, discusses the themes of the upcoming ASH Annual Meeting & Exposition 2023, taking place December 9-12 in San Diego, CA.

Transcript

Can you briefly speak to the themes of ASH 2023 and their importance in the space right now?

There are a number of themes that emerge in the annual meeting every year, and with over 7000 abstracts, it's no surprise that it's hard to actually choose which themes we're going to focus on. A big one is focusing on health equity in hematology, and there are a number of ways that's being done. And I wanted to highlight a couple of abstracts that really focus on health equity, if that's okay. One abstract is comparing the efficacy in clinical trials vs effectiveness in real-world treatments for multiple myeloma, which is a population-based cohort study. And this area of looking at how people actually do on a drug fascinates me. Part of the reason is that I served on and chaired the Oncologic Drugs Advisory Committee at the FDA, so we saw the data that were coming in for drugs that were looking for FDA approval, and you realize that the people being enrolled onto these clinical trials are like Olympic athletes. And then when we're sitting 3 feet away from a person in our exam room, we always struggle with how well a person who has multiple comorbidities is going to do on the same drug where those comorbidities were excluded from clinical trials. In fact, in this study, patients in the real world had a 44% faster time to relapse and 75% worse overall survival with the same exact myeloma regimens as patients who are enrolled on the clinical trials. So I think it emphasizes that we have to probably modulate the expectations of our patients when they're going on to a drug, particularly if they have multiple comorbidities. Those are aspects of treatment that particularly affect vulnerable populations, and that's why we consider that in the health equity aspect.

Another study that I really loved looked at psychiatric and substance use disorders in patients who had newly diagnosed acute myeloid leukemia (AML) treated with standard regimens of therapy that we give to anyone with AML, and it found that those patients who had either psychiatric diagnoses or substance use disorders had significantly worse treatment response and survival—even controlling for age, disease related factors, organ function, and other things—than people who don't have those aspects of their being that they have to deal with. So, it again identifies a vulnerable population we might not have thought of otherwise.

In terms of clinical practice impact, what research are you excited to see at ASH 2023?

When I look at what is either going to change practice or confirm the way we're approaching practice, there are a couple of abstracts that come to mind.

The first is a late-breaking abstract that looked at 4 drugs to treat multiple myeloma versus 3 drugs. The 4 drugs are daratumumab, bortezomib, lenalidomide, and dexamethasone vs those drugs without the daratumumab—and this trial clearly showed a significant improvement in progression-free survival for patients who got the 4 drugs, as opposed to those who got the 3 drugs. This is already the way that we're practicing in the US. This randomized phase 3 trial confirms that benefit and probably will allow for the 4 drug regimen to get approved in other parts of the world. So, that's an example of where I think it's more practice confirming.

Another area where it's practice confirming are a couple of trials that had abstracts that combined ibrutinib and venetoclax vs ibrutinib alone in lymphoid malignancies. One of these looked at patients who have relapsed or refractory mantle cell lymphoma, and another of these studies looked at the combination in patients who had previously untreated chronic lymphocytic leukemia. And in both cases, the combination of ibrutinib plus venetoclax provided benefit to patients in terms of progression-free survival compared to ibrutinib alone. So [with] combination therapies coming of age, some people would actually argue non-chemotherapy approaches, non–classic chemotherapy approaches to treating lymphoid malignancies are now the standard of care.

Is there anything else you would like to highlight ahead of this year's meeting?

In general, the American Society of Hematology Annual Meeting is the biggest event in hematology of the year. And this year, we're anticipating the largest attendance ever combined, and we'll probably be getting pretty close to 30,000 people live in San Diego, so it's a great meeting, there's a lot of energy around it. In addition to the scientific sessions, there are also educational or spotlight sessions. I always like to go to the ASH-FDA sessions on new drugs. I like those because you have a representative from the FDA presenting the data that led to a drug's approval, and then you have a clinician who says, "Okay, we've got this new drug, how are we really going to use it? How are we going to use it on label, how are we going to use it off label, and what side effects are we really going to see on our patients that we're going to worry about?" I love that because it's a very practical aspect of how we think about how we're going to use new drugs. There's also a spotlight session on donor risks and social justice, which I think is going to be addressing the LGBTQ+ population and their ability to donate blood and what some of the issues are around that.

So, always cool stuff, always something to see at the annual meeting. Our biggest obstacle is always choosing what it is we're going to go to at any given time.