Dr Phull on the Rationale for the Retrospective Analysis of CAR T-Cell Therapy in R/R Myeloma

“It's important to see how [clinical trial data] compare to our real-world outcomes in our [patients with] multiple myeloma in the clinic that we're seeing every day, now that [the CARTITUDE-1 and KarMMA-1] trials have really matured, and we have a lot of long-term data on them.”

Pooja Phull, MD, hematologist/oncologist, John Theurer Cancer Center, Hackensack University Medical Center, discusses the rationale for assessing ciltacabtagene autoleucel (cilta-cel; Carvykti) and idecabtagene vicleucel (ide-cel; Abecma) in real-world patients with relapsed/refractory multiple myeloma.

Within the past few years, CAR T-cell therapy has helped improve the treatment paradigm for patients with multiple myeloma in the short and long term, Phull begins. She notes that follow-up data from the phase 1b/2 CARTITUDE-1 (NCT03548207) and phase 2 KarMMA-1 (NCT03361748) trials have now matured, which provides a clearer picture of the respective long-term data.

Of note, the CARTITUDE-1 trial evaluated cilta-cel in heavily pretreated patients with relapsed/refractory multiple myeloma. At a median follow-up of 33.4 months, the median duration of response (DOR), progression-free survival (PFS), and overall survival were 33.9 months (95% CI, 25.5-not estimable [NE]), 34.9 months (95% CI, 25.2-NE), and not reached, respectively, according to final results of the study.

The KarMMA-1 study investigated ide-cel in patients with relapsed/refractory multiple myeloma. At a median follow-up of 13.3 months, 73% of patients (n = 94/128) experienced a response, of which 33% had a complete response or better. Notably, the median DOR, PFS, and OS were 10.7 months (95% CI, 9.0-11.3), 8.8 months (95% CI, 5.6-11.6), and 19.4 months (95% CI, 18.2-NE), respectively.

Therefore, the retrospective analysis helped shed light on real-world data compared with known data from the 2 respective trials, Phull explains. She emphasizes that many patients with relapsed/refractory multiple myeloma in the real-world setting often do not meet the eligibility criteria that are expected for clinical trials. Nevertheless, it’s crucial to compare these data to understand the effect of these CAR T-cell therapies in the real-world setting, Phull concludes.