Yi Lin MD, PhD, discusses the impact of the phase 1b/2 CARTITUDE-1 study of ciltacabtagene autoleucel for the treatment of relapsed or refractory multiple myeloma.
Yi Lin MD, PhD, a hematologist/oncologist, consultant, Division of Hematology, Department of Internal Medicine, enterprise leader, Cancer Regenerative Medicine, Biotherapeutics, and Biomanufacturing, Mayo Clinic Comprehensive Cancer Center, associate medical director, Center for Regenerative Biotherapeutics, and consultant, Division of Experimental Pathology and Laboratory Medicine, Department of Laboratory Medicine and Pathology, discusses the impact of the phase 1b/2 CARTITUDE-1 study (NCT03548207) of ciltacabtagene autoleucel (cilta-cel; Carvykti) for the treatment of relapsed or refractory multiple myeloma.
In the study, cilta-cel treatment led to a longer median progression-free survival (PFS) compared with standard of care.
0:07 | As you know, this is a very exciting time for the field of multiple myeloma, we're having more and more treatment options, including immunotherapy options, which are some of the most exciting ones, just seeing the response rate and even the PFS duration for many of these patients. So, we're certainly very glad to see so cilta-cel has been FDA approved.
0:31 | In the first year in transition to clinical practice, there were a lot of challenges with manufacturing access for this in the practice. But in a very recent months, we're seeing some improvements. So, we hope that will translate into more access for our patients. What we are seeing now with clinical trial results that were reported at ASCO are also very exciting. [This was a] randomized control study comparing cilta-cel with other standard of care therapy options for myeloma patients in earlier line settings. And that also matters primary end point of showing that patients who received cilta-cel had longer PFS. And so, we're anticipating that FDA will review that and either, you know, by the end of this year beginning next year, hopefully we'll have a decision on if the CAR T can move into earlier-line setting for these patients.
1:42 | There are ongoing trials for cilta-cel also now in the frontline setting, we're seeing some very encouraging signals for how this CAR T is performing, both for patients who have very early relapse after first-line therapy or not the most ideal response to first-line therapy, or even as part of the first-line therapy. So, there is plan to open a randomized control study as well to formally compare cilta-cel with standard of care treatment options, even in the frontline setting.