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Cilta-Cel Yields 100% ORR in Patients With Early Relapse of Multiple Myeloma

Niels van de Donk, MD, PhD, professor, Amsterdam University Medical Centers, discussed positive findings from cohort B of the CARTITUDE-2 study.

"Cilta-cel has now shown efficacy in early relapse and end stage patients... Because of the high efficacy of cilta-cel in high-risk populations and end stage myeloma, cilta-cel is not only moving to 1 to 3 prior lines, but there are also now several studies that will soon start enrolling patients in the first line. We hope to see that cilta-cel is really superior to autologous stem cell transplant and will improve the clinical outcomes of newly diagnosed myeloma patients.”

Ciltacabtagene autoleucel (cilta-cel; Carvykti; Janssen) yielded deep and durable responses, including a 100% overall response rate (ORR), in patients with multiple myeloma (MM) and early relapse after initial therapy, according to data from cohort B of the phase 2 CARTITUDE-2 study (NCT04133636).

These data were presented at the 2022 American Society of Clinical Oncology (ASCO) meeting, held June 3-7, 2022, held both virtually and in Chicago, Illinois by Niels van de Donk, MD, PhD, professor, cancer immunology and hematology, Amsterdam University Medical Centers.

Cohort B of CARTITUDE-2 has infused 19 patients, mostly male (74%) with a median age of 58.0 years (range, 44-67), as of January 2022. Patients had a median follow-up of 13.4 months (range, 5.2-21.7) and 79% had received prior autologous stem cell transplant.

Investigators found that ORR was 100.0%, complete response rate was 90%, very good partial response rate was 95%, and 12-month progression free survival rate was 90%. The median time to first response was 0.95 months (range, 0.9–9.7) and median time to best response was 5.1 months (range, 0.9-11.8). Almost all minimal residual disease-evaluable patients (n = 14/15; 93%) achieved MRD 10-5 negativity. Median duration of response was not reached and 12-month event-free rate was 88.9%.

READ MORE: Exploring New Paths for CAR T-Cell Therapy Research in Multiple Myeloma

Cilta-cel had a predictable and manageable safety profile. Grade 3/4 adverse events (AEs) included neutropenia (n = 17), anemia (n = 9), thrombocytopenia (n = 5), lymphopenia (n = 6), and leukopenia (n = 5). Most patients (84%) experienced cytokine release syndrome. Most cases were mild, excepting 1 grade 3/4 case, and all cases resolved. The median time to onset of CRS was 8 days (range, 5–11).

One grade 1 case of immune effector cell-associated neurotoxicity syndrome did occur as well as 1 case of a grade 3 movement and neurocognitive treatment-emergent AE with symptoms of parkinsonism. One death occurred due to progressive disease at day 158 after cilta-cel infusion. Pharmocokinetic analyses revealed that peak CAR-T cellexpansion occurred on day 13.1 (range, 8.96–209.9) and median persistence was 76.9 days (range, 40.99–221.8).

CGTLive spoke with van de Donk to learn more about the unmet needs in this cohort population and the new findings from the study. He discussed ongoing and future research with cilta-cel, including bringing the therapy up to early lines of treatment.

To read more coverage of ASCO 2022, click here.

van de Donk NWCJ, Agha ME, Cohen AD, et al. Biological correlative analyses and updated clinical data of ciltacabtageneautoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, in patients with multiple myeloma (MM) and early relapse after initial therapy: CARTITUDE-2, cohort B. Presented at: 2022 ASCO Annual Meeting, June 3-7, 2022. Poster #453.