The director of Clinical Research in Hematologic Malignancies at Levine Cancer Institute discussed overall response rate and stringent complete responses in the CARTITUDE-1 trial.
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CancerNetwork spoke with Saad Z. Usmani, MD, MBA, FACP, of the Levine Cancer Institute in Charlotte, North Carolina, at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting about the overall response and complete response rates of patients with relapsed/refractory multiple myeloma treated with ciltacabtagene autoleucel (cilta-cel) from the CARTITUDE-1 trial.
At the 12.4-month follow-up at [the American Society for Hematology Annual Meeting], the overall response rate was 97% and the stringent [complete response (CR)] rate was 67%. At that time, because of the follow up period, the 12-month [progression-free survival (PFS)], and overall survival (OS)] rates were reported at 77% and 89%. With this further follow-up, what we’re finding is an overall response rate of 98%. The response rate has improved because we have another evaluable patient and the responses have deepened, so a stringent CR rate of 80.4% was observed. The median time to best response and median time to CR or better were 2.6 months. The median duration of response for the whole population—again, because of not having enough follow-up, you have to take this with a grain of salt—the median duration of response is 21.8 months and I suspect that with subsequent follow-up, that may actually improve because most of the patients are [in] stringent CR, and the duration of response in those patients hasn’t been reached.
The 18-month PFS and OS rates are 66% and 81%. With the follow-up, the PFS and OS continue to be quite impressive. We did not see any new safety signals. As we know with CAR T-cell therapy, most of the [adverse] effects tend to happen earlier in the course and since patients are not on any ongoing treatment, their quality of life continues to improve and that’s what we saw here.