Looking forward, Andrzej Jakubowiak, MD, PhD, anticipates CAR T-cell therapy with ciltacabtagene autoleucel will establish its place across various indications for multiple myeloma.
In an interview with CancerNetwork® at the 63rd American Society of Hematology Annual Meeting & Exposition, Andrzej Jakubowiak, MD, PhD, director of the Myeloma Program at University of Chicago Medicine, who presented data regarding the benefits of CAR T-cell therapy with ciltacabtagene autoleucel (cilta-cel) in subgroups of patients with relapsed/refractory multiple myeloma treated in CARTITUDE-1 trial (NCT03548207), spoke about how the treatment has the potential to impact the treatment landscape.
We are evaluating cilta-cel, which was used in CARTITUDE-1 and a number of ongoing studies. CARTITUDE-2 [NCT04133636] for example, has cohorts with high-risk patients on earlier lines of therapy, so this particular question [regarding who benefits with cilta-cel treatment] is further addressed in those particular subgroups of patients with earlier lines of therapy. A number of other studies are in progress, including evaluation of cilta-cel in newly diagnosed patients, both transplant candidates, which is at the drawing board [as] something we may potentially evaluate, and there is [an ongoing] study in newly diagnosed patients who are not transplant candidates. There are some other studies in progress and being planned.
There is a high anticipation that cilta-cel will be approved in the early part of . The PDUFA [Prescription Drug User Fee Act] date is February 28, 2022, which we are anticipating will bring availability of this treatment to patients on who meet criteria which will be defined by the FDA. At the moment [in 2021], it is not yet approved. It will be [continually evaluated] in clinical trials, some of which are in progress, and some being planned as well as in commercial use once this CAR T-cell therapy is approved
As a physician who is treating myeloma and who has a lot of patients with disease events without any other options, I am very anxiously awaiting approval of this drug because I see that I can potentially use this treatment in patients who otherwise will be left without any treatment. [The potential] is so dramatic that I cannot express it more clearly. We really need this type of treatment, and this is one which we are anticipating most for this patient population, with high response rates and high complete responses. [In the overall patient population], progression-free [survival] has not been reached at 2 years and is exceeding 60% for patients who achieve stringent complete response, which was about 80% [or more].
Jakubowiak A, Usmani SZ, Berdeja J, et al. Efficacy and safety of ciltacabtagene autoleucel in patients with relapsed/refractory multiple myeloma: CARTITUDE-1 subgroup analysis. Blood. 2021;138(suppl 1):3938. doi:10.1182/blood-2021-146069