Hematologic Highlights from ASCO 2025: CARTITUDE-1 and STARGLO

Following the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Pharmacy Times^® met with Matthew Lei, PharmD, BCOP, clinical pharmacy specialist, lymphoma, Massachusetts General Hospital, Boston, to discuss key abstracts featuring hematologic data. He highlighted the CARTITUDE-1 trial (NCT03548207) and STARGLO trial (NCT04408638) and described how the findings can set a benchmark for future research in the multiple myeloma and lymphoma spaces. Additionally, Lei acknowledged certain challenges that may arise with these treatments, such as the increased risk of infections and other toxicities.

Pharmacy Times: Can you introduce yourself?

Matthew Lei, PharmD, BCOP: My name is Matt. I'm a pharmacist that specializes in lymphoma at Massachusetts General Hospital in Boston.

Pharmacy Times: Can you discuss some key hematologic research that was presented at this year’s ASCO Annual Meeting?

Lei: To start us off, I think one notable abstract that was presented was the 5-year survival follow-up from the CARTITUDE-1 trial (NCT03548207). I think that data readout was notable because it did show that a single infusion of ciltacabtagene autoleucel (cilta-cel, Carvykti; Janssen Biotech) in patients who had relapsed/refractory multiple myeloma [had the] potential for a durable, long-term remission. Whether that translates to a cure is a little bit early, but it does show a potential that nearly a third of patients may benefit for quite a long time from a single infusion. I think this now sets a benchmark [and sets one] for trials going forward, and I think it also allows us to be able to say, "Okay, this is possible," and previously, we didn't have evidence to show this.

And one of the limitations of cilta-cel in a broad-use patient population—given its current approval in second-line and refractory patients—is the potential for more concerning long-term toxicities, or later toxicities, in terms of the neurotoxicities, and also the more readily described, as of late, enterocolitis that can be associated with cilta-cel. And so, I think with this data readout, I think there's growing excitement in being able to translate this benefit to a broader patient population, as well as moving it up in early lines of therapy. Granted, though we'll have to be able to mitigate the potential toxicities and select the appropriate patients thereof.

Another abstract of interest that was represented at ASCO—specifically in patients with large B cell lymphoma—was the phase 3 STARGLO trial (NCT04408638). And so, in [this] trial, patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after 2 prior lines of therapy were randomized to either glofitamab (Columvi; Genentech)-GemOx (Glofit-GemOx) or rituximab (R, Rituxan; Genentech)-GemOx, and this was the 2-year survival update for this trial. And so, with the updated 2-year data, we see that similar median progression-free survival and CR rates, and what is notable is that after the 2-year follow-up, most patients were still in a CR. And so, the CR rate with Glofit-GemOx was 58.5% versus 25.3% with R-GemOx, and it does show that with a follow-up, there is durability to CRs with Glofit-GemOx. And it'll be exciting to see whether or not this regimen will go back to FDA review after additional data that was recommended at the Oncologic Drugs Advisory Committee (ODAC) meeting.

I think this also challenges how we look at both inclusion and CCN as it relates to FDA ODAC review and also FDA approvals. I think what is notable, at least from the US perspective, is that with both epcoritamab (Epkinly; AbbVie)-GemOx and Glofit-GemOx, index and CCN are recommended regimens in this space in the second-line [setting] that might impact treatment selection and also informed consent, as if a patient were to enroll on trial, and there's a perfectly good second-line option, how would patients go through that decision-making process, which is quite complex? And also, [this] begs into question that if a regimen is not FDA-approved or voted against at the ODAC meeting, should a National Comprehensive Cancer Network (NCCN) recommendation be withdrawn? And so, I think it brings up a lot of conversations around both regimens that are going to be voted for inclusion in NCCN based on early data readouts and also how that is viewed upon by—at least from a US perspective—the FDA.

Pharmacy Times: When implementing these innovations into practice, what challenges do you foresee, and how can we overcome them?

Lei: I think potential challenges with the inclusion of, for example, glofitamab and also, for epcoritamab and early lines of therapy, at least for DLBCL, and in the very near future, second-line for follicular lymphoma, are that the overall patient population that has access to these therapies will increase, and so, are institutions set up to be able to handle the number of patients? And also, when you have various TCEs across the disease state groups, there are going to be disease state and also line of therapy nuances to toxicity management as well. And so, it's just a lot of things that you keep track of from either the pharmacists' perspectives or from the providers, the APPs, the RNs, or even our administrative staff with scheduling. It's quite a complex workload, and so, even being able to operationalize it will have institutional challenges, but also, even from a patient perspective as well, there's a bunch of nuance, again, depending on the disease, state, and line of therapy. And so, how do patients stay informed and also receive that level of education required to go through that therapy and feel supported?

I think that, along with the toxicities with T cell engagers—in this context, CD20xCD3 bispecific antibodies—while there's a lot of focus on cytokine release syndromes (CRS) and immune cell effector neurotoxicity syndrome (ICANS), [another] notable toxicity is going to be the risk for infection. Although most of the infectious morbidity and potential mortality is associated with the periods of initial treatment, the risk could also remain, especially when you have either extended treatment durations or a treat-until-progression timeframe. And so, for patients, to be able to adequately educate and inform them, to report and contact their health care provider with any signs and symptoms of infection, but also to ensure that any recommended guideline-based infection monitoring and also prophylaxis are implemented. And so, I think along with the risk of CRS and ICANS, we should also just be aware of the risk for infections, and also sometimes, uncommon infections, especially in patients receiving these types of therapies.