In the first study to report real-world outcomes from ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR)-T therapy for multiple myeloma, patients experienced efficacy and safety results similar to those seen in clinical trials, according to results published in Blood . Of 236 patients who received cilta-cel infusions at 16 U.S.
medical centers in 2022, 89% saw their cancer respond to the treatment and 70% had a complete response, meaning there was no detectable cancer after the treatment. These numbers are comparable to the results of the phase II CARTITUDE-1 trial that led to cilta-cel's approval by the U.S.
Food and Drug Administration (FDA), which showed a 98% response rate and an 83% complete response rate. Most notable and encouraging, according to researchers, was that over half of the patients included in the new study would have been ineligible to participate in CARTITUDE-1. "Even though in the real world a majority of patients are not as fit in terms of performance status, organ function, or baseline blood counts as they were in the clinical trial that led to FDA approval [of this therapy], these patients can do very well," said Surbhi Sidana, MD, the study's lead author and associate professor at Stanford University School of Medicine.
"We saw very high response rates that appeared to be durable, despite over half of the patients not meeting [the trial's] eligibility criteria. The response rates and time until progression of myeloma or death du.