Dr Siegel on the Importance of Real-World Data in Patients With Multiple Myeloma

David Samuel Dicapua Siegel, MD, medical oncologist, chief, Myeloma Division, John Theurer Cancer Center, Hackensack University Medical Center, discusses the importance of utilizing real-world evidence when making treatment considerations, specifically in the treatment of patients with relapsed/refractory multiple myeloma, emphasizing the need for real-world investigations in this patient population.

Transitioning from clinical trials to real-world applications poses a complex challenge for patients with relapsed/refractory multiple myeloma, Siegel begins. Clinical trials are bound by strict eligibility criteria, resulting in a highly selected participant pool, Siegel says. Conversely, real-world data offer a more inclusive perspective, he states. In the realm of myeloma management, the focus has shifted toward CAR T cells and T-cell engagers, with 2 main commercially available products–idecabtagene vicleucel (ide-cel; Abecma) and ciltacabtagene autoleucel (cilta-cel; Carvykti)–gaining prominence, Siegel explains. Notably, ide-cel received FDA approval in March 2021 and cilta-cel was granted FDA approval in February 2022, both for the treatment of adult patients with relapsed/refractory multiple myeloma following 4 or more prior lines of therapy.

Real-world outcomes with ide-cel and cilta-cel echo findings from the pivotal clinical trials, affirming the remarkable efficacy of both therapies, he expands. In the real-world setting, ide-cel exhibits slightly lower effectiveness than cilta-cel, a finding which aligns with clinical trial observations, Siegel states. However, ide-cel boasts the advantages of lower toxicity and enhanced applicability vs cilta-cel, ensuring a higher likelihood of successful product manufacturing and expedited delivery to patients, he emphasizes. Siegel goes on to say that these factors are crucial for a subset of patients facing time constraints, for whom the risk of manufacturing failure or prolonged waiting periods, as seen with ide-cel, is not feasible.

Although real-world data support these observations, making direct comparisons between ide-cel and cilta-cel remains a challenge, he continues. Patients with more severe conditions tend to opt for the product with greater manufacturing reliability and shorter turnaround time, raising ongoing questions that require comprehensive exploration, Siegel concludes.