ASH 2024 | HRQoL in patients with R/R CTCL treated with lacutamab in the TELLOMAK trial

So this year at the ASH we presented the quality of life data from a clinical trial called TELLOMAK. So TELLOMAK is a Phase II multi-cohort international clinical trial that enrolls patients with Sézary syndrome and mycosis fungoides which are together the two most common types of CTCL. Sézary syndrome is rare, about five percent of all the CTCLs, but it’s very aggressive and patients have a poor survival. Mycosis fungoides, on the other hand, represents about 50 to 60 percent of all CTCL and it has a greater spectrum of clinical activity and progression. So some patients are early stage, some patients, as I mentioned, are kind of a more advanced stage. And regardless, however, there is a significant need for new drugs in both diseases and TELLOMAK enrolled two different cohorts, one cohort specifically for Sézary syndrome and then a number of additional cohorts for mycosis fungoides based on the expression of a marker called KIR3DL2. 

So TELLOMAK essentially is a trial exploring monotherapy with a drug called lacutamab, which is a monoclonal antibody targeting KIR3DL2. And as I mentioned, you know, the trial has already completed accrual, efficacy and safety data were presented both for Sézary syndrome last year at ASH and for mycosis fungoides at this year’s ASCO. And what we presented this year are the quality of life data as well as the translational science that were presented as a poster on Saturday. 

So regarding the quality of life data… First of all, quality of life is a very important endpoint for CTCL patients because they have a multitude of skin symptoms that really kind of affect profoundly their well-being, both in terms of personal as well as the social well-being of patients. And so quality of life is very heavily impacted and any therapy that, in addition to having, you know, direct antitumor efficacy really needs to prove that there is an improvement in quality of life. 

So we measure quality of life using two validated instruments. One for itching specifically, that is called visual analog scale, VAS, that essentially ranks the patient’s symptoms in terms of itching from one being the least degree of itch to 10 being the worst possible itch. The second tool was something called Skindex-29, which is a composite global quality of life assessment tool, which is a survey that is given to the patients to compile. And it measures symptoms over the previous four weeks according to three different domains. One of them is symptoms, one of them is emotional, and the other one is functional, and then the scores are sort of, there’s a median in terms of the score that is composed out of those three. 

What we saw at baseline… First of all, all patients on the TELLOMAK were given surveys to complete longitudinally during the course of the trial, and we had a very high completion of the surveys. So, 80% of the surveys were completed, so we have a very high density data set for the quality of life. What we observed was that at baseline the vast majority of the patients had severe scores on both the Skindex-29 and the VAS scale and that with treatment starting at week five, so very early on during the treatment for both Sézary syndrome and mycosis fungoides, the scores came down significantly. And all the way to week 45 and all the way to week 81. For some patients at week 81, the severity, we had no patients with severe scores, and they all came down to mild or moderate scores. 

So this study really kind of proves that the quality of life on patients on lacutamab is clearly improved and the duration is durable – these improvements lasted during the treatment. Even more importantly, we score patients based on response, of course, so we didn’t see any major difference in terms of the ultimate improvement in quality of life between responders and non-responders, excluding progressors, so patients with stable disease had a very similar downtrend in the severity of their quality of life scores, except for being delayed. So, you know, the responders had a faster improvement and the patients who had stable disease had a slower improvement. At the end, they all improved.

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